biotecMAX™ October/September/August/July 2020 insight

https://seekingalpha.com/symbol/INCY

Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

To learn more about Lilly, please visit us at lilly.com

For additional information on Incyte, please visit Incyte.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-has-significant-effect-on-recovery-time-most-impactful-in-covid-19-patients-requiring-oxygen-301148840.html

Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen

October 8, 2020 DownloadPDF Format (opens in new window)Further results from NIAID-sponsored ACTT-2 Trial Presented Today

INDIANAPOLIS , Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY)

https://investor.incyte.com/press-releases/press-releases/2020/Baricitinib-has-Significant-Effect-on-Recovery-Time-Most-Impactful-in-COVID-19-Patients-Requiring-Oxygen/default.aspx

Olumiant is a prescription medicine used to treat adults with moderately to severely active rheumatoid arthritis (RA) who have tried at least one other medicine called a tumor necrosis factor (TNF) antagonist that did not work well enough or could not be tolerated. The medicine comes in a tablet and is taken orally.

Cologuard®

Exact Sciences and Pfizer Extend and Amend Cologuard® Promotion Agreement

Wed October 7, 2020 6:11 AM|PR Newswire|About: EXAS, PFEPR Newswire

MADISON, Wis. and NEW YORK, Oct. 7, 2020 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (PFE)

For more information about Cologuard, visit www.cologuardtest.com.

In addition, to learn more, please visit us on www.pfizer.com

For more information, please visit the company's website at www.exactsciences.com,

View original content to download multimedia:http://www.prnewswire.com/news-releases/exact-sciences-and-pfizer-extend-and-amend-cologuard-promotion-agreement-301147497.html

https://seekingalpha.com/symbol/EXAS

https://www.exactsciences.com/innovative-science/the-pipeline

Exact Sciences And Pfizer Extend And Amend Cologuard® Promotion Agreement

10/07/2020Successful collaboration will continue to support Cologuard adoption through 2022

MADISON, Wis. and NEW YORK, Oct. 7, 2020 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE)

https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2020/Exact-Sciences-and-Pfizer-Extend-and-Amend-Cologuard-Promotion-Agreement/default.aspx

Cologuard is intended to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older.

Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL)

Lilly and Dexcom team up on new program to help improve diabetes management

Wed October 7, 2020 6:30 AM|PR Newswire|About: DXCM, LLYPR Newswire

INDIANAPOLIS and SAN DIEGO, Oct. 7, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and DexCom, Inc. (DXCM)

https://www.lyumjev.com/

Those interested in learning more about Dexcom CGM or getting started on the Dexcom G6 should visit Dexcom.com.

People with diabetes and their HCPs who have questions about Lyumjev can visit www.Lyumjev.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 a.m. to 8 p.m. ET.

For more information, call 1-800-545-5979 or go to www.Lyumjev.com or www.humalog.com

Please see Lyumjev Full Prescribing Information including Patient Prescribing Information

Please see Humalog Full Prescribing Information including Patient Prescribing Information

https://seekingalpha.com/symbol/DXCM

https://investor.lilly.com/news-releases/news-release-details/lilly-and-dexcom-team-new-program-help-improve-diabetes

Lilly and Dexcom team up on new program to help improve diabetes management

October 7, 2020

We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/

View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-and-dexcom-team-up-on-new-program-to-help-improve-diabetes-management-301147221.html

https://seekingalpha.com/news/3620364-lilly-teams-up-dexcom-for-diabetes-management

Lyumjev: A fast-acting mealtime insulin Lyumjev, pronounced: (LOOM-jehv) Sound high icon Lyumjev provides proven A1C reduction in adults with type 1 and type 2 diabetes It is designed to reduce blood sugar spikes that happen naturally after a meal Fast-acting insulins like Lyumjev control after-meal blood sugar, similar to how natural insulin works after meals in people without diabetes

OPDIVO ® (nivolumab)

Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

Wed October 7, 2020 6:59 AM|Business Wire|About: BMY

CheckMate -816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery

Positive results mark the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy versus chemotherapy as neoadjuvant therapy in a Phase 3 trial in resectable non-small cell lung cancer

Opdivo-based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

Phase 3 clinical trial, CheckMate-816, evaluating the combination of Opdivo (nivolumab) and chemo administered before surgery in patients with resectable non-small cell lung cancer.

OPDIVO ® (nivolumab)

https://news.bms.com/news/corporate-financial/2020/Opdivo-nivolumab-Plus-Chemotherapy-Shows-Statistically-Significant-Improvement-in-Pathologic-Complete-Response-as-Neoadjuvant-Treatment-of-Resectable-Non-Small-Cell-Lung-Cancer-in-Phase-3-CheckMate--816-Trial/default.aspx

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer

ADVANCED LUNG CANCER

NON-SMALL CELL LUNG CANCER

SMALL CELL LUNG CANCER

OPDIVO for people who have had prior treatments for small cell lung cancer

Choose your condition:

Advanced Lung Cancer
Advanced Kidney Cancer
Advanced Liver Cancer
Colorectal Cancer (MSI-H/dMMR)
Advanced Esophageal Squamous Cell Cancer
Melanoma
Head and Neck Squamous Cell Cancer
Advanced Bladder Cancer
Classical Hodgkin Lymphoma

Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

10/07/2020CATEGORY:

Corporate/Financial News

CheckMate -816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery

Opdivo-based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201007005273/en/

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer BACK ADVANCED LUNG CANCER NON-SMALL CELL LUNG CANCER OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1 OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer OPDIVO for people who have had prior treatments for non-small cell lung cancer SMALL CELL LUNG CANCER OPDIVO for people who have had prior treatments for small cell lung cancer Choose your condition: Advanced Lung Cancer Advanced Kidney Cancer Advanced Liver Cancer Colorectal Cancer (MSI-H/dMMR) Advanced Esophageal Squamous Cell Cancer Melanoma Head and Neck Squamous Cell Cancer Advanced Bladder Cancer Classical Hodgkin Lymphoma

Palynziq® (pegvaliase-pqpz) Injection

BioMarin, Pioneer in Rare Disease Treatments for Phenylketonuria (PKU), Receives FDA Approval of Label Expansion to Allow Maximum Dose of 60 mg for Palynziq® (pegvaliase-pqpz) Injection for Treatment of Adults with PKU

Wed October 7, 2020 8:31 AM|PR Newswire|About: BMRN

BioMarin 15+ Years of Commitment to PKU Community Through Long-Term Study of Existing Approved Therapies and Ongoing Efforts to Develop New Treatments

PR Newswire

SAN RAFAEL, Calif., Oct. 7, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

Palynziq® (pegvaliase-pqpz) Injection

https://www.palynziq.com/hcp/

https://www.palynziq.com/

INDICATION

PALYNZIQ® (pegvaliase-pqpz) Injection is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 µmol/L on existing management.

PALYNZIQ® (pegvaliase-pqpz) Injection for PKU

https://www.biomarin.com/products/palynziq/#:~:text=Indication,dL)%20on%20their%20current%20treatment.

To learn more about PKU and PAH deficiency, please visit www.PKU.com.

For additional information, please visit www.BMRN.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/biomarin-pioneer-in-rare-disease-treatments-for-phenylketonuria-pku-receives-fda-approval-of-label-expansion-to-allow-maximum-dose-of-60-mg-for-palynziq-pegvaliase-pqpz-injection-for-treatment-of-adults-with-pku-301147358.html

https://seekingalpha.com/symbol/BMRN

INDICATION PALYNZIQ® (pegvaliase-pqpz) Injection is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 µmol/L on existing management.

ZEPOSIA® (ozanimod)

Health Canada Approves ZEPOSIA®, an Oral Treatment for Relapsing Remitting Multiple Sclerosis

Wed October 7, 2020 8:00 AM|Canada Newswire|About: BMY

Bristol Myers Squibb's medication provides a new oral treatment option for Canadians living with the neurological disease

MONTREAL, Oct. 7, 2020 /CNW/ - Bristol Myers Squibb

ZEPOSIA® (ozanimod)

https://www.zeposia.com/

INDICATION

ZEPOSIA® (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if ZEPOSIA is safe and effective in children.

Please see full Prescribing Information, including Medication Guide.

For more information, please visit https://www.bms.com/ca/en.

For more information about Bristol Myers Squibb, visit us at BMS.com

INDICATION ZEPOSIA® (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if ZEPOSIA is safe and effective in children. Please see full Prescribing Information, including Medication Guide.

REGN-COV2 investigational antibody

Oct 7, 2020

Regeneron seeks FDA emergency clearance for COVID-19 therapy

Robert Langreth, Bloomberg News

Regeneron seeks FDA emergency use nod for COVID-19 therapy

Oct. 7, 2020 10:55 PM ET|About: Regeneron Pharmaceuticals, ... (REGN)|By: Carl Surran, SA News Editor

https://seekingalpha.com/news/3620656-regeneron-seeks-fda-emergency-use-nod-for-covidminus-19-therapy

Pres. Trump received the antibody cocktail last Friday after becoming sick with the coronavirus, and lauded Regeneron's treatment in a video posted on Twitter today, saying he would authorize its emergency use and make it available to Americans for free.

https://www.regeneron.com/pipeline

A POWERFUL RESEARCH AND
DEVELOPMENT ENGINE

September 29, 2020 at 4:01 PM EDT Back REGENERON'S REGN-COV2 ANTIBODY COCKTAIL REDUCED VIRAL LEVELS AND IMPROVED SYMPTOMS IN NON-HOSPITALIZED COVID-19 PATIENTS TARRYTOWN, N.Y., Sept. 29, 2020 /PRNewswire/ -- Greatest improvements in patients who had not mounted their own effective immune response prior to treatment Plan rapidly to discuss results with regulatory authorities Regeneron to host investor and media webcast to discuss results at 4:30 pm ET today Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

Islatravir in Combination With Doravirine

Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection

Save

October 8, 2020 6:45 am EDT

Treatment With Islatravir and Doravirine Maintained Viral Suppression and No Viral Resistance was Identified

Company Also Presenting Phase 1/1b Results for MK-8507, a New Investigational Once-Weekly Oral HIV Agent; Company Advances MK-8507 to Phase 2

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced Week 96 data from the Phase 2b trial (NCT03272347) evaluating the efficacy and safety of islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO™), in treatment-naïve adults with HIV-1 infection.

Merck HIV combo regimen shows sustained benefit in mid-stage HIV study

Oct. 8, 2020 7:45 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3620729-merck-hiv-combo-regimen-shows-sustained-benefit-in-mid-stage-hiv-study

Week 96 data from a Phase 2b clinical trial evaluating Merck's (NYSE:MRK) islatravir, an oral nucleoside reverse transcriptase translocation inhibitor, combined with Pifeltro (doravirine)

https://www.merckconnect.com/doravirine/clinical-efficacy/pifeltro-lipid-profile/

Islatravir in Combination With Doravirine

About Islatravir (MK-8591)

Islatravir (formerly MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, as well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single investigational agent, across a variety of formulations.

Indications

Indications for PIFELTRO and DELSTRIGO:

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

Indications Indications for PIFELTRO and DELSTRIGO: PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

GENOTROPIN® (somatropin)

https://seekingalpha.com/pr/18036104-pfizer-announces-positive-phase-3-top-line-results-for-weekly-investigational-long-acting

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005030/en/

GENOTROPIN® (somatropin)

https://www.genotropin.com/

INDICATIONS

GENOTROPIN is a prescription product for the treatment of growth failure in children:

Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD)
With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor
Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA)
With a genetic condition called Turner syndrome (TS)
With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause

GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

announce positive results from a Phase 3 clinical trial evaluating weekly injections of somatrogon compared to daily injections of Genotropin (somatropin) in children aged three to less than 18 years with growth hormone deficiency (GHD).

For more information, visit http://www.OPKO.com.

About Somatrogon©

https://www.opko.com/what-we-do/our-research/somatrogon

In addition, to learn more, please visit us on www.pfizer.com

PFIZER ANNOUNCES POSITIVE PHASE 3 TOP-LINE RESULTS FOR ONCE-WEEKLY INVESTIGATIONAL LONG-ACTING HUMAN GROWTH HORMONE TO TREAT CHILDREN WITH GROWTH HORMONE DEFICIENCY

Thursday, October 08, 2020 - 06:45am

– Results demonstrated improved treatment burden with once-weekly injection –

NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK)

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-phase-3-top-line-results-once

https://seekingalpha.com/symbol/OPK

INDICATIONS GENOTROPIN is a prescription product for the treatment of growth failure in children: Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD) With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA) With a genetic condition called Turner syndrome (TS) With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

Veklury® (remdesivir)

Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)

Thu October 8, 2020 3:00 AM|Business Wire|About: GILD

– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU and EEA –

– Greatly Expanded Supply of Veklury Expected to Meet European Real-Time Demand and Stockpiling Needs in October –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences (GILD)

Veklury® (remdesivir)

please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

For more information on Gilead’s response to the coronavirus outbreak, please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201008005332/en/

Gilead Sciences signs joint procurement agreement with EC for remdesivir

Oct. 8, 2020 3:36 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3620668-gilead-sciences-signs-joint-procurement-agreement-ec-for-remdesivir

https://www.fiercepharma.com/pharma/gilead-sciences-remdesivir-reduces-covid-19-mortality-new-analysis?mkt_tok=eyJpIjoiTnpKbFl6VTBNVEF5WmpVeiIsInQiOiJrTDlQdHNDbGVTTm1WMGJqR1QzYW5qbEpCWWVZcHFOaUpHWUFKZHZma1BGc2dvbk4rNjBJUWd5QjhaOVJWRXJCTHpORzFwSkMrbFg5NncrVjh4YUZHWGd5SStrOThyeTdtdHI4NlRtMmJkNHJwS2xJdk13T0hEUmpKeXhFaFpibWF2dlYzdWRFMnlkZ3hoWlU2dzd4K3c9PSJ9&mrkid=15444103

Gilead Sciences' remdesivir cuts COVID-19 death risk in patients on low-flow oxygen

by Eric Sagonowsky | Oct 9, 2020 9:13am

October 08, 2020

Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)

– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU and EEA –

– Greatly Expanded Supply of Veklury Expected to Meet European Real-Time Demand and Stockpiling Needs in October –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences (Nasdaq: GILD) and the European Commission

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/gilead-sciences-signs-joint-procurement-agreement-with-the-european-commission-for-veklury-remdesivir

Innovation

An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences

Daniel O’Day - October 08, 2020

https://stories.gilead.com/articles/an-open-letter-from-our-chairman-and-ceo-oct-8

October 08, 2020 Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19 -- Final Day 29 Data Show Superior Efficacy of Veklury Compared with Placebo in Hospitalized Patients Receiving Standard of Care -- -- Overall, Treatment with Veklury Resulted in Five Days Faster Recovery and Reduced Disease Progression Compared with Placebo -- -- Veklury Reduced Mortality by 70 Percent at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc Analysis -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- The New England Journal of Medicine(NEJM) today published the final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled, Phase 3 ACTT-1 trial of Gilead’s (Nasdaq: GILD) investigational antiviral Veklury® (remdesivir) for the treatment of adults hospitalized with mild-moderate or severe COVID-19.

Nivatrotamab, a humanized bispecific anti-GD2 antibody

Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA

Wed October 7, 2020 9:00 AM|GlobeNewswire|About: YMAB

NEW YORK, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (YMAB)

Nivatrotamab, a humanized bispecific anti-GD2 antibody

https://ymabs.com/

https://seekingalpha.com/symbol/YMAB

Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA

NEW YORK , Oct. 07, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, todayRead moreOct 07, 2020

About the Y-mAbs development pipeline of therapies

LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb)

Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs

Wed October 7, 2020 8:30 AM|PR Newswire|About: AMGN, LLY

- New data show combination therapy met primary and secondary endpoints, reducing viral load, symptoms and hospitalizations; EUA request to follow

- Plan to initiate a large open-label pragmatic study in COVID-19 outpatients in October

- Media and investor call to be held at noon EDT today

PR Newswire

INDIANAPOLIS, Oct. 7, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)

positive preliminary results in a mid-stage study, BLAZE-1, evaluating its anti-SARS-CoV-2 neutralizing antibodies in COVID-19 patients with mild-to-moderate illness, Eli Lilly (NYSE:LLY)

LY-CoV555 monotherapy

The BLAZE-1 clinical trial (NCT04427501) continues to enroll a confirmatory cohort of higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19, testing the ability of the antibody combination to reduce the number of patients with persistent high viral load and reduce COVID-related hospitalizations.

To learn more about Lilly, please visit us at www.lilly.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-provides-comprehensive-update-on-progress-of-sars-cov-2-neutralizing-antibody-programs-301147631.html

https://seekingalpha.com/pr/18036107-lilly-announces-arrangement-for-supply-of-potential-covidminus-19-antibody-therapy-for-low

Lilly Announces Arrangement for Supply of Potential COVID-19 Antibody Therapy for Low- and Middle-Income Countries

Thu October 8, 2020 6:45 AM|PR Newswire|About: LLY

INDIANAPOLIS, Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and the Bill & Melinda Gates Foundation,

For more information, visit www.therapeuticsaccelerator.org

View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-announces-arrangement-for-supply-of-potential-covid-19-antibody-therapy-for-low--and-middle-income-countries-301148217.html

Lilly Announces Arrangement for Supply of Potential COVID-19 Antibody Therapy for Low- and Middle-Income Countries

October 8, 2020

https://investor.lilly.com/news-releases/news-release-details/lilly-announces-arrangement-supply-potential-covid-19-antibody

Lilly doublet therapy for COVID-19 reduced hospitalizations in mid-stage study

Oct. 8, 2020 11:19 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3620846-lilly-doublet-therapy-for-covidminus-19-reduced-hospitalizations-in-mid-stage-study

Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs October 7, 2020

biotecMAX™ October/September/August/July 2020 insight

VIR-7831 (GSK4182136)

Vaccine Candidate BNT162b2

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19

Tue October 6, 2020 8:18 AM|GlobeNewswire|About: GSK, VIR

Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in
Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021
If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19
Patient enrollment underway; website live at https://vircovid19study.com/

SAN FRANCISCO and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR) and GlaxoSmithKline plc (GSK)

For more information, please visit www.vir.bio.

https://seekingalpha.com/symbol/VIR

For further information please visit www.gsk.com/about-us.

https://www.vir.bio/pipeline/#focus

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19 10/06/20 at 8:18 AM EDT PDF Version Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021 If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19 Patient enrollment underway; website live at https://vircovid19study.com/ SAN FRANCISCO and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK)

Vaccine Candidate BNT162b2

BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2

Tue October 6, 2020 5:01 AM|GlobeNewswire|About: BNTX

Rolling review accepted by the EMA based on available preclinical and clinical data for BNT162b2 to date
BioNTech (NTGN) and Pfizer will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study

NEW YORK and MAINZ, GERMANY, October 6, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (BNTX) (Nasdaq: BNTX)

For further information about the ongoing Phase 3 trial, visit www.ClinicalTrials.gov using the number NCT04368728.

www.Pfizer.com

For more information, please visit www.BioNTech.de.

https://seekingalpha.com/symbol/BNTX

BIONTECH AND PFIZER INITIATE ROLLING SUBMISSION TO EUROPEAN MEDICINES AGENCY FOR SARS-COV-2 VACCINE CANDIDATE BNT162B2 Tuesday, October 06, 2020 - 07:00amEDT Rolling review accepted by the EMA based on available preclinical and clinical data for BNT162b2 to date BioNTech and Pfizer will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study NEW YORK and MAINZ, GERMANY, October 6, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)

ZEJULA (niraparib)

Vaccine Candidate BNT162b2

Investigational KRAS G12C Inhibitor Sotorasib

ZEJULA is approved in Canada for first-line maintenance treatment of women with advanced ovarian cancer Français

MISSISSAUGA, ON, Oct. 5, 2020 /CNW/ - ZEJULA (niraparib) is now approved in Canada for the monotherapy maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapyi.

ZEJULA (niraparib)

https://www.zejula.com/en

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

https://seekingalpha.com/news/3619905-canada-oks-expanded-use-of-glaxos-zejula-in-ovarian-cancer

https://www.gsk.com/en-gb/products/our-prescription-medicines/#

Indication ZEJULA is a prescription medicine used for the: maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with: a certain "BRCA" gene mutation, or gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that ZEJULA is right for you.

Investigational KRAS G12C Inhibitor Sotorasib

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

Investigational KRAS G12C Inhibitor Sotorasib

Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer

Mon October 5, 2020 4:30 PM|PR Newswire|About: AMGN

Safety and Tolerability Similar to Previously Reported Phase 1 Results in Patients with Non-Small Cell Lung Cancer

PR Newswire

THOUSAND OAKS, Calif., Oct. 5, 2020 /PRNewswire/ -- Amgen (AMGN)

Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC)

To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com.

For more information, visit www.amgen.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-announces-positive-topline-phase-2-results-for-investigational-kras-g12c-inhibitor-sotorasib-in-advanced-non-small-cell-lung-cancer-301145947.html

https://seekingalpha.com/symbol/AMGN

Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer Durable Anticancer Activity Observed in Patients Whose Cancer Had Progressed Despite Prior Treatment With Chemotherapy and/or Immunotherapy Safety and Tolerability Similar to Previously Reported Phase 1 Results in Patients with Non-Small Cell Lung Cancer THOUSAND OAKS, Calif., Oct. 5, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

Gilead Presents Biktarvy® Findings From Switch Studies & Analysis of Real-World BICSTaR Study At HIV Glasgow 2020

Mon October 5, 2020 6:00 AM|Business Wire|About: GILD, GLD

-- People Living With HIV Switching to Biktarvy from Boosted PI-Based Regimens Achieved Sustained Viral Suppression up to 156 Weeks --

-- Ongoing Switch Study in Population Aged 65 Years and Older Shows Biktarvy Sustains Viral Suppression Through 72 weeks --

-- Clinical and Patient Reported Outcomes in People Living With HIV on Biktarvy Treatment in the international BICSTaR Study Demonstrated Consistent Therapeutic Effectiveness and Long-term Safety Profile in Real-World Practice Settings --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) (Nasdaq: GLD)

https://seekingalpha.com/pr/18030340-gilead-presents-biktarvy-findings-from-switch-studies-analysis-of-real-world-bicstar-study

For more information about Gilead, please visit the company’s website at www.gilead.com,

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005394/en/

October 05, 2020

Gilead Presents Biktarvy® Findings From Switch Studies & Analysis of Real-World BICSTaR Study At HIV Glasgow 2020

-- People Living With HIV Switching to Biktarvy from Boosted PI-Based Regimens Achieved Sustained Viral Suppression up to 156 Weeks --

-- Ongoing Switch Study in Population Aged 65 Years and Older Shows Biktarvy Sustains Viral Suppression Through 72 weeks --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc.

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/gilead-presents-biktarvy-findings-from-switch-studies--analysis-of-realworld-bicstar-study-at-hiv-glasgow-2020

https://www.biktarvy.com/

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

https://seekingalpha.com/news/3619711-gileads-biktarvy-shows-sustained-long-term-benefit-in-range-of-studies

What is BIKTARVY®? BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 55 pounds. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Aimovig® (erenumab-aooe)

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

Novartis announces five-year data that reinforce the safety and efficacy profile of Aimovig® (erenumab-aooe) in adult patients with episodic migraine

Sat October 3, 2020 4:05 AM|PR Newswire

Aimovig has the longest duration of safety and efficacy trial data for any anti-CGRP pathway therapy

Five-year open-label extension study shows patients continued to experience a sustained benefit; Aimovig maintained a consistent safety profile

PR Newswire

EAST HANOVER, N.J., Oct. 3, 2020 /PRNewswire/ -- Novartis

Aimovig® (erenumab-aooe)

https://www.aimovig.com/

About the Open Label Extension Phase of the Phase 2 Study in Episodic Migraine Prevention (NCT01952574)

Results from the five-year, open-label treatment period of a Phase 2 study

Please see Aimovig® full Prescribing Information.

For more information, please visit https://www.novartis.us.

View original content to download multimedia:http://www.prnewswire.com/news-releases/novartis-announces-five-year-data-that-reinforce-the-safety-and-efficacy-profile-of-aimovig-erenumab-aooe-in-adult-patients-with-episodic-migraine-301145144.html

https://seekingalpha.com/symbol/NVS

Novartis announces five-year data that reinforce the safety and efficacy profile of Aimovig® (erenumab-aooe) in adult patients with episodic migraine

Oct 03, 2020

Results presented at the Migraine Trust Virtual Symposium highlight long-term benefit of Aimovig
Aimovig has the longest duration of safety and efficacy trial data for any anti-CGRP pathway therapy
Five-year open-label extension study shows patients continued to experience a sustained benefit; Aimovig maintained a consistent safety profile

EAST HANOVER, N.J., Oct. 3, 2020 /PRNewswire/ -- Novartis today announced that results reinforcing the long-term safety and efficacy profile of Aimovig® (erenumab-aooe) in patients with episodic migraine (EM) are being presented at the Migraine Trust Virtual Symposium. Results from the five-year, open-label

https://www.novartis.us/news/media-releases/novartis-announces-five-year-data-reinforce-safety-and-efficacy-profile-aimovig

https://seekingalpha.com/symbol/AMGN

Novartis/Amgen Aimovig shows positive effect in patients with episodic migraine

Oct. 5, 2020 12:01 AM ET|About: Novartis AG (NVS)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3619662-novartis-amgen-aimovig-shows-positive-effect-in-patients-episodic-migraine

Approved Use Aimovig® is a prescription medicine used for the preventive treatment of migraine in adults.

Opdivo® (nivolumab) + Yervoy® (ipilimumab)

BMN-307, an investigational gene therapy for the treatment of phenylketonuria.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

Fri October 2, 2020 4:12 PM|Business Wire|About: BMY

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2

Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1

Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Announces-Update-on-CheckMate--915-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Versus-Opdivo-in-Resected-High-Risk-Melanoma-Patients/default.aspx

For more information about Bristol Myers Squibb, visit us at BMS.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005481/en/

Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients

10/02/2020

CATEGORY:

Corporate/Financial News

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://www.opdivo.com/about-opdivo/how-the-combination-works-combinationtherapy

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

10/02/2020

CATEGORY:

Corporate/Financial News

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2

Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1

Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://news.bms.com/news/corporate-financial/2020/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab--Yervoy-ipilimumab-as-the-First-and-Only-Immunotherapy-Treatment-for-Previously-Untreated-Unresectable-Malignant-Pleural-Mesothelioma/default.aspx

How do OPDIVO® (nivolumab) and YERVOY® (ipilimumab) team up to fight cancer differently than chemotherapy? OPDIVO + YERVOY works by helping your immune system to fight cancer. It does this by combining 2 immunotherapy medications that work in different but complementary ways. Together, OPDIVO and YERVOY can help your immune system launch a response against cancer that's greater than when either medication is used alone.

BMN-307, an investigational gene therapy for the treatment of phenylketonuria.

BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307

Fri October 2, 2020 8:31 AM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., Oct. 2, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

To learn more about PKU and PAH deficiency, please visit www.PKU.com.

For additional information, please visit www.biomarin.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/biomarin-pioneer-in-phenylketonuria-pku-and-gene-therapy-receives-fda-fast-track-designation-for-pku-investigational-gene-therapy-bmn-307-301144678.html

https://seekingalpha.com/symbol/BMRN

https://www.biomarin.com/products/pipeline

BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 3072nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU CommunityOct 2, 2020

https://investors.biomarin.com/2020-10-02-BioMarin-Pioneer-in-Phenylketonuria-PKU-and-Gene-Therapy-Receives-FDA-Fast-Track-Designation-for-PKU-Investigational-Gene-Therapy-BMN-307

Pipeline BioMarin is actively developing promising first-in-class or best-in-class therapies to treat rare genetic diseases, which mostly affect children.

CRYSVITA® (burosumab)

BMN-307, an investigational gene therapy for the treatment of phenylketonuria.

CRYSVITA® (burosumab)

Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults

Fri October 2, 2020 8:00 AM|Business Wire|About: KNBWY, KYKOY

More people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH, a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3

TOKYO--(BUSINESS WIRE)-- Kyowa Kirin Co., Ltd. (KYKOF) (TSE: 4151, Kyowa Kirin)

CRYSVITA® (burosumab)

https://www.crysvita.com/hcp/

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Kyowa Kirin International
http://www.international.kyowa-kirin.com / www.kyowakirin.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005246/en/

https://seekingalpha.com/symbol/KYKOF

Kyowa Kirin is developing the med in collaboration with Ultragenyx (NASDAQ:RARE).

https://seekingalpha.com/symbol/RARE

https://seekingalpha.com/symbol/KNBWY

https://www.kyowakirin.com/what_we_do/index.html#anc-pipeline

Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults

Fri October 2, 2020 8:00 AM|Business Wire|About: KNBWY, KYKOY

TOKYO--(BUSINESS WIRE)-- Kyowa Kirin Co., Ltd. (KYKOF) (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) has approved CRYSVITA® (burosumab)

https://seekingalpha.com/pr/18029249-kyowa-kirin-announces-european-commission-ec-approval-of-crysvita-burosumab-for-treatment-of

View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005246/en/

Indication CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23)–blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

avalglucosidase alfa

elivaldogene autotemcel (eli-cel, Lenti-D™)

CRYSVITA® (burosumab)

EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease

Fri October 2, 2020 1:00 AM|GlobeNewswire|About: SNY

EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease

Avalglucosidase alfa, an investigational enzyme replacement therapy for patients with Pompe disease, reaches its first important regulatory milestone
Pompe disease affects an estimated 50,000 people worldwide
Submission based on positive data from two trials including both infantile-onset and late-onset Pompe disease patients
Regulatory approval in Europe anticipated in the second half of 2021
Milestone builds on company’s 20+ year commitment to the Pompe disease community
Avalglucosidase alfa receives Promising Innovative Medicine designation in UK, adding to U.S. Breakthrough Therapy designation received earlier this year

PARIS – October 2, 2020 –The European Medicines Agency (EMA)

EMA accepts Sanofi's marketing application for avalglucosidase for Pompe disease

Oct. 2, 2020 1:24 AM ET|About: Sanofi (SNY)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3619273-ema-accepts-sanofis-marketing-application-for-avalglucosidase-for-pompe-disease

https://seekingalpha.com/symbol/SNY

October 02 2020 EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease

elivaldogene autotemcel (eli-cel, Lenti-D™)

bluebird bio Announces European Medicines Agency’s Acceptance of Marketing Authorization Application (MAA) for elivaldogene autotemcel (eli-cel, Lenti-D™) Gene Therapy for Cerebral Adrenoleukodystrophy (CALD)

Fri October 2, 2020 5:00 AM|Business Wire|About: BLUE

European Medicines Agency will evaluate eli-cel MAA under accelerated assessment

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE)

For more information about bluebird bio-sponsored studies visit: www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov.

For more information, visit bluebirdbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005065/en/

EMA accepts bluebird bio's marketing application for eli-cel gene therapy for neurodegenerative disorder

Oct. 2, 2020 5:28 AM ET|About: bluebird bio, Inc. (BLUE)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3619291-ema-accepts-bluebird-bios-marketing-application-for-eli-cel-gene-therapy-for

https://seekingalpha.com/symbol/BLUE

https://www.bluebirdbio.com/our-science/pipeline

bluebird bio Announces European Medicines Agency’s Acceptance of Marketing Authorization Application (MAA) for elivaldogene autotemcel (eli-cel, Lenti-D™) Gene Therapy for Cerebral Adrenoleukodystrophy (CALD)

European Medicines Agency will evaluate eli-cel MAA under accelerated assessment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 2, 2020-- bluebird bio, Inc. (Nasdaq: BLUE)

http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-european-medicines-agencys-acceptance-0

product candidates

Zeposia® (ozanimod)

elivaldogene autotemcel (eli-cel, Lenti-D™)

Bristol Myers Squibb to Host Virtual Investor Event to Discuss Results from Phase 3 True North Trial Evaluating Zeposia® (ozanimod) in Ulcerative Colitis at UEG Week 2020

Fri October 2, 2020 6:59 AM|Business Wire|About: BMY

NEW YORK--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)

Zeposia® (ozanimod)

https://www.zeposia.com/

For more information about Bristol Myers Squibb, visit us at BMS.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005023/en/

results from a Phase 3 clinical trial, True North, evaluating Zeposia (ozanimod) in patients with moderate-to-severe ulcerative colitis. In June, it announced that the study met the both primary endpoints and key secondary endpoints.

https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-to-Host-Virtual-Investor-Event-to-Discuss-Results-from-Phase-3-True-North-Trial-Evaluating-Zeposia-ozanimod-in-Ulcerative-Colitis-at-UEG-Week-2020/default.aspx

Bristol Myers Squibb to Host Virtual Investor Event to Discuss Results from Phase 3 True North Trial Evaluating Zeposia® (ozanimod) in Ulcerative Colitis at UEG Week 2020

10/02/2020CATEGORY:

Corporate/Financial News

NEW YORK--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)

biotecMAX™ September/August/July 2020 insight

Farxiga (dapagliflozin)

investigational gene therapy candidate (PF-06939926)

Resolute Onyx™ Drug Eluting Stent (DES)

Farxiga granted Breakthrough Therapy Designation in US for chronic kidney disease

PUBLISHED2 October 2020

2 October 2020 07:00 BST

Designation follows DAPA-CKD Phase III trial results in which Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease

AstraZeneca’s Farxiga nabs accelerated review in U.S. for kidney disease

Oct. 2, 2020 6:44 AM ET|About: AstraZeneca PLC (AZN)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3619311-astrazeneca-s-farxiga-nabs-accelerated-review-in-u-s-for-kidney-disease

Farxiga (dapagliflozin)

https://www.farxiga.com/

What is FARXIGA? FARXIGA is a prescription medicine used to: improve blood sugar control along with diet and exercise in adults with type 2 diabetes reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

Resolute Onyx™ Drug Eluting Stent (DES)

investigational gene therapy candidate (PF-06939926)

Resolute Onyx™ Drug Eluting Stent (DES)

Medtronic Resolute Onyx™ Drug Eluting Stent (DES) First to Receive One-Month DAPT Labeling in the U.S. with Expanded Indication for High Bleeding Risk Patients

Thu October 1, 2020 8:00 AM|PR Newswire|About: MDT

DUBLIN, Oct. 1, 2020 /PRNewswire/ -- Medtronic plc (MDT)

the approval is based on results from the Onyx ONE Clear Study that evaluated approximately 1500 complex HBR patients on one-month DAPT treated with Resolute Onyx.

www.medtronic.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/medtronic-resolute-onyx-drug-eluting-stent-des-first-to-receive-one-month-dapt-labeling-in-the-us-with-expanded-indication-for-high-bleeding-risk-patients-301143577.html

https://seekingalpha.com/symbol/MDT

Medtronic Resolute Onyx™ Drug Eluting Stent (DES) First to Receive One-Month DAPT Labeling in the U.S. with Expanded Indication for High Bleeding Risk Patients

DUBLIN, Oct. 1, 2020 /PRNewswire/ -- Medtronic plc (NYSE:MDT)

https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-resolute-onyxtm-drug-eluting-stent-des-first-receive

Resolute Onyx™ Drug-Eluting Stent

investigational gene therapy candidate (PF-06939926)

Pfizer Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Investigational Gene Therapy

Thu October 1, 2020 6:45 AM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

https://seekingalpha.com/pr/18026881-pfizer-receives-fda-fast-track-designation-for-duchenne-muscular-dystrophy-investigational

View source version on businesswire.com: https://www.businesswire.com/news/home/20201001005382/en/

PF-06939926 is currently being evaluated in a Phase 1 study. A Phase 3 should launch in the coming weeks.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-fda-fast-track-designation-duchenne

https://www.pfizer.com/

PFIZER RECEIVES FDA FAST TRACK DESIGNATION FOR DUCHENNE MUSCULAR DYSTROPHY INVESTIGATIONAL GENE THERAPY Thursday, October 01, 2020 - 06:45am NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE)

SIMPONI ARIA® (golimumab)

mRNA Vaccine Against COVID-19 (mRNA-1273)

investigational gene therapy candidate (PF-06939926)

SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

Wed September 30, 2020 8:58 AM|PR Newswire

Phase 3 GO-VIVA clinical trial adds to the growing body of evidence for SIMPONI ARIA

SIMPONI ARIA is a 30-minute IV infusion administered by a health care professional once every eight weeks after starter doses at weeks 0 and 4

PR Newswire

HORSHAM, Pa., Sept. 30, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

SIMPONI ARIA® (golimumab)

https://www.simponiaria.com/

Please read the full Prescribing Information and Medication Guide for SIMPONI ARIA® and discuss any questions you have with your doctor.

Learn more at www.janssen.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/simponi-aria-golimumab-approved-by-the-us-food-and-drug-administration-for-active-polyarticular-juvenile-idiopathic-arthritis-and-extension-of-its-active-psoriatic-arthritis-indication-in-patients-2-years-of-age-and-older-301141976.html

https://seekingalpha.com/symbol/JNJ

SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

Sep 30, 2020United States

SIMPONI ARIA is the first and only fully human anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous (IV) infusion approved for pediatric use in both active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA)

Phase 3 GO-VIVA clinical trial adds to the growing body of evidence for SIMPONI ARIA

SIMPONI ARIA is a 30-minute IV infusion administered by a health care professional once every eight weeks after starter doses at weeks 0 and 4

HORSHAM, Pa., Sept. 30, 2020 -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://www.janssen.com/simponi-aria-golimumab-approved-us-food-and-drug-administration-active-polyarticular-juvenile

WHAT IS SIMPONI ARIA®? SIMPONI ARIA® is for adults with: Moderate to severe rheumatoid arthritis, used in combination with methotrexate Active psoriatic arthritis Active ankylosing spondylitis

UPTRAVI® (selexipag) Injection

mRNA Vaccine Against COVID-19 (mRNA-1273)

Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)

Wed September 30, 2020 7:00 AM|PR Newswire

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

UPTRAVI® (selexipag) Injection

https://www.uptravi.com/

Please see full Prescribing Information.

Learn more at www.janssen.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/janssen-submits-new-drug-application-nda-to-us-fda-for-uptravi-selexipag-injection-for-intravenous-use-to-treat-pulmonary-arterial-hypertension-pah-301140441.html

Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)

Sep 30, 2020United States

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2020 -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://www.janssen.com/janssen-submits-new-drug-application-nda-us-fda-uptravi-selexipag-injection-intravenous-use-treat

https://seekingalpha.com/symbol/JNJ

J&J files U.S. application for IV selexipag for high blood pressure in lung arteries

Sep. 30, 2020 7:18 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3618313-j-and-j-files-u-s-application-for-iv-selexipag-for-high-blood-pressure-in-lung-arteries

What is UPTRAVI? UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs. UPTRAVI can help delay (slow down) the progression of your disease and lower your risk of being hospitalized for PAH. It is not known if UPTRAVI is safe and effective in children.

mRNA Vaccine Against COVID-19 (mRNA-1273)

Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)

Tue September 29, 2020 6:17 PM|Business Wire|About: MRNA

mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 (n=10) and 71+ (n=10) age cohorts

Potent neturalization responses were confirmed by 3 different live virus assays

mRNA-1273 elicited Th1-biased CD4 T cell responses in the 56-70 and 71+ age cohorts

Neutralizing antibody titers and T cell responses in the 56-70 and 71+ age cohorts were consistent with those reported in younger adults

At the 25 µg and 100 µg dose levels, mRNA-1273 was generally well-tolerated in all age cohorts

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (MRNA), (Nasdaq: MRNA)

The New England Journal of Medicine.

The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the NIH and BARDA, began on July 27.

To learn more, visit www.modernatx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200929006145/en/

https://seekingalpha.com/symbol/MRNA

SEPTEMBER 29, 20205:05 PMUPDATED 3 HOURS AGO

Moderna COVID-19 vaccine appears safe, shows signs of working in older adults - study

By Julie Steenhuysen

https://uk.reuters.com/article/us-health-coronavirus-moderna/moderna-covid-19-vaccine-appears-safe-shows-signs-of-working-in-older-adults-study-idUSKBN26K3KE

Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)

September 29, 2020 at 6:17 PM EDTPDF Version

mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 (n=10) and 71+ (n=10) age cohorts

Potent neutralization responses were confirmed by 3 different live virus assays

mRNA-1273 elicited Th1-biased CD4 T cell responses in the 56-70 and 71+ age cohorts

Neutralizing antibody titers and T cell responses in the 56-70 and 71+ age cohorts were consistent with those reported in younger adults

At the 25 µg and 100 µg dose levels, mRNA-1273 was generally well-tolerated in all age cohorts

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 29, 2020-- Moderna, Inc., (Nasdaq: MRNA

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-publication-new-england-journal-medicine-0

Moderna's COVID vaccine generates strong immune response in older adults

Sep. 29, 2020 7:21 PM ET|About: Moderna, Inc. (MRNA)|By: Carl Surran, SA News Editor

https://seekingalpha.com/news/3618245-modernas-covid-vaccine-generates-strong-immune-response-in-older-adults

Enrollment Update: 27,232 participants enrolled in the COVE Phase 3 Study as of Friday, September 25, 2020 at 5:00 pm ET 15,454 participants have received their second vaccination.

REGN-COV2 Antibody Cocktail

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection)

Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients

Tue September 29, 2020 4:01 PM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Sept. 29, 2020 /PRNewswire/ --

Greatest improvements in patients who had not mounted their own effective immune response prior to treatment

Plan rapidly to discuss results with regulatory authorities

Regeneron to host investor and media webcast to discuss results at 4:30 pm ET today

Regeneron Pharmaceuticals, Inc. (REGN)

Phase 1/2/3 clinical trial evaluating its antibody cocktail, REGN-COV2, plus standard-of-care treatment in non-hospitalized COVID-19 patients.

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and-improved-symptoms-in-non-hospitalized-covid-19-patients-301140336.html

View original content:http://www.prnewswire.com/news-releases/tyvyt-sintilimab-injection-in-combination-with-byvasda-bevacizumab-injection-orient-32-study-met-its-primary-endpoints-of-progression-free-survival-and-overall-survival-in-the-first-line-treatment-of-patients-with-advanced-h-301138710.html

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection)

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection) ORIENT-32 Study Met Its Primary Endpoints of Progression-Free Survival and Overall Survival in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma (HCC)

Sun September 27, 2020 10:15 PM|PR Newswire|About: IVBIY

SAN FRANCISCO and SUZHOU, China, Sept. 27, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: (1801)

ORIENT-32 is a Phase 3 randomized, open-label, multi-center study to evaluate the efficacy and safety of TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT 03794440).

For more information, please visit: www.innoventbio.com.

Note:
TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection) is not an approved product in the United States.
SULINNO® (adalimumab biosimilar injection) is not an approved product in the United States.

TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
ALIMTA® and GEMZAR® are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

https://seekingalpha.com/symbol/IVBIY

Phase 3 ORIENT-32 trial of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection,

http://innoventbio.com/#/

NNOVENT BIOLOGICS, INC. (1801)

https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=1801&sc_lang=en

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection) ORIENT-32 Study Met Its Primary Endpoints September 29, 2020, 11:14 AM EDT

XELJANZ® (tofacitinib)

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection)

REBLOZYL® (luspatercept)

U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

Mon September 28, 2020 4:54 PM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

XELJANZ® (tofacitinib)

https://www.xeljanz.com/

Please see full Prescribing Information, including BOXED WARNING for XELJANZ/XELJANZ XR available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

In addition, to learn more, please visit us on www.pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200928005729/en/

https://seekingalpha.com/symbol/PFE

U.S. FDA APPROVES PFIZER’S XELJANZ® (TOFACITINIB) FOR THE TREATMENT OF ACTIVE POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS

Monday, September 28, 2020 - 04:54pm

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE)

https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-xeljanzr-tofacitinib-treatment

XELJANZ (tofacitinib) is the first and only pill of its kind (JAK inhibitor) that treats adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis.

REBLOZYL® (luspatercept)

Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia

Tue September 29, 2020 6:59 AM|Canada Newswire

REBLOZYL® is the first and only erythroid maturation agent approved for use in Canada

MONTREAL, Sept. 29, 2020 /CNW/ - Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc.

For more information about Bristol Myers Squibb, visit us at BMS.com

For more information, please visit www.acceleronpharma.com.

https://www.reblozyl.com/

http://acceleronpharma.com/science-pipeline/pipeline/

Sep 29, 2020

Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia

PDF Version

REBLOZYL® is the first and only erythroid maturation agent approved for use in Canada

MONTREAL & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 29, 2020-- Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. (NASDAQ:XLRN)

http://investor.acceleronpharma.com/news-releases/news-release-details/health-canada-approves-reblozylr-luspatercept-new-class

https://seekingalpha.com/symbol/XLRN

WHAT IS REBLOZYL® (luspatercept-aamt)? REBLOZYL is a prescription medicine used to treat anemia (low red blood cells) in adults with: beta thalassemia who need regular red blood cell (RBC) transfusions. myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular RBC transfusions and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA). REBLOZYL is not for use as a substitute for RBC transfusions in people who need immediate treatment for anemia. It is not known if REBLOZYL is safe or effective in children.

Evrysdi™ (risdiplam)

REBLOZYL® (luspatercept)

Nucala (mepolizumab)

Genentech Presents New 2-Year Data for Evrysdi (risdiplam) in Infants With Type 1 Spinal Muscular Atrophy (SMA)

Mon September 28, 2020 1:00 AM|Business Wire|About: RHHBY

– Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years –

– 59% of infants were able to sit without support for at least 5 seconds –

– No new safety signals were identified –

– In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

two-year data from Part 1 of the pivotal Phase 2/3 FIREFISH study evaluating Evrysdi (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA).

https://www.evrysdi.com/

PTC Therapeutics Portfolio Pipeline

https://www.ptcbio.com/our-pipeline/portfolio-pipeline/

Roche and PTC's risdiplam shows durable effect in infants with spinal muscular atrophy

Sep. 28, 2020 6:44 AM ET|About: PTC Therapeutics, Inc. (PTCT)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3617548-roche-and-ptcs-risdiplam-shows-durable-effect-in-infants-spinal-muscular-atrophy

https://seekingalpha.com/symbol/PTCT

https://seekingalpha.com/symbol/RHHBY

https://www.gene.com/

Sunday, Sep 27, 2020

Genentech Presents New 2-Year Data for Evrysdi (risdiplam) in Infants With Type 1 Spinal Muscular Atrophy (SMA)

Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years
59% of infants were able to sit without support for at least 5 seconds
No new safety signals were identified
In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older

South San Francisco, CA -- September 27, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones.

https://www.gene.com/media/press-releases/14883/2020-09-27/genentech-presents-new-2-year-data-for-e

What is Evrysdi? Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. It is not known if Evrysdi is safe and effective in children under 2 months of age.

Nucala (mepolizumab)

REBLOZYL® (luspatercept)

Nucala (mepolizumab)

25 September 2020

FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES)

Issued: 25 September 2020, London UK

Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases

GlaxoSmithKline plc (GSK)

https://www.gsk.com/en-gb/

https://www.nucala.com/

FDA OKs Glaxo's Nucala for rare immune system disorder

Sep. 25, 2020 4:29 PM ET|About: GlaxoSmithKline plc (GSK)|By: Manshi Mamtora, CFA, SA News Editor

https://seekingalpha.com/news/3617443-fda-oks-glaxos-nucala-for-rare-immune-system-disorder

NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.

biotecMAX™ September/August/July 2020 insight

SRP-9003 (rAAVrh74.MHCK7.hSGCB)

Sarepta Therapeutics Investigational Gene Therapy SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E Shows Sustained Functional Improvements 18-months After Administration

Mon September 28, 2020 8:55 AM|GlobeNewswire|About: SRPT

-- Continued functional improvements were observed at 18 months in the low-dose cohort --

-- First look at functional outcomes in high-dose cohort found improvements 6 months after administration --

-- Results in both cohorts continue to reinforce safety and tolerability profile of SRP-9003 --

CAMBRIDGE, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics (SRPT), Inc. (NASDAQ:SRPT)

The Company’s programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com

Sarepta Therapeutics Investigational Gene Therapy SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E Shows Sustained Functional Improvements 18-months After Administration

09/28/20 8:55 AM EDT

-- Continued functional improvements were observed at 18 months in the low-dose cohort --

-- First look at functional outcomes in high-dose cohort found improvements 6 months after administration --

-- Results in both cohorts continue to reinforce safety and tolerability profile of SRP-9003 --

CAMBRIDGE, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-investigational-gene-therapy-srp-9003

SRP-9003 in limb-girdle muscular dystrophy:

https://seekingalpha.com/symbol/SRPT

https://www.sarepta.com/science/gene-therapy-engine

Essential Components of Gene Therapy

FreeStyle® Libre 3 System

SRP-9003 (rAAVrh74.MHCK7.hSGCB)

Abbott's FreeStyle® Libre 3 System Receives CE Mark - Features World's Smallest, Thinnest Sensor with Best-in-Class Performance at the Same Low Cost for People with Diabetes

Mon September 28, 2020 9:00 AM|PR Newswire|About: ABT

- With the smallest and thinnest[3] wearable glucose sensor (about the size of two stacked U.S. pennies), FreeStyle Libre 3 users can view their glucose levels discreetly[4] and conveniently,[5] anytime[6]

- Building on the proven FreeStyle Libre 2 sensor performance with a new sensor design at the same affordable price as previous versions,[7] the FreeStyle Libre 3 system is the latest innovation of Abbott's world-leading[8] continuous glucose monitoring technology

PR Newswire

ABBOTT PARK, Ill., Sept. 28, 2020 /PRNewswire/ -- Abbott (ABT)

Connect with us at www.abbott.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/abbotts-freestyle-libre-3-system-receives-ce-mark--features-worlds-smallest-thinnest-sensor-with-best-in-class-performance-at-the-same-low-cost-for-people-with-diabetes-301138719.html

https://www.freestylelibre.us/

https://seekingalpha.com/symbol/ABT

Check your glucose with a painless1 scan - instead of a fingerstick.* Diabetes is complex enough. Monitoring your diabetes shouldn’t be.

elezanumab (ABT-555)

SRP-9003 (rAAVrh74.MHCK7.hSGCB)

ULTOMIRIS® (ravulizumab)

AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury

Mon September 28, 2020 8:00 AM|PR Newswire|About: ABBV

- Orphan Drug Designation is given to a drug or biologic for the treatment, diagnosis or prevention of a rare disease or condition¹

- Fast Track Designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs²

PR Newswire

NORTH CHICAGO, Ill., Sept. 28, 2020 /PRNewswire/ -- AbbVie (ABBV)

Elezanumab is being investigated to treat spinal cord injuries, multiple sclerosis and acute ischemic stroke. It is currently in a phase 2 study (NCT04295538) for the treatment of spinal cord injury.

For more information, go to www.sralab.org.

For more information, please visit www.abbvie.com.

View original content:http://www.prnewswire.com/news-releases/abbvie-receives-orphan-drug-and-fast-track-designations-from-the-us-food-and-drug-administration-for-elezanumab-an-investigational-monoclonal-antibody-rgma-inhibitor-for-the-treatment-of-spinal-cord-injury-301138702.html

https://seekingalpha.com/symbol/ABBV

September 28, 2020 AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury

ULTOMIRIS® (ravulizumab)

COVID-19 vaccine candidate, JNJ-78436735

ULTOMIRIS® (ravulizumab)

ULTOMIRIS® (ravulizumab) Receives Approval in Japan for Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Children

Fri September 25, 2020 8:30 AM|Business Wire|About: ALXN

– ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS, reducing the treatment burden for adults and children with administration every other month –

– ULTOMIRIS has the potential to become the new standard of care in Japan for the treatment of aHUS, an ultra-rare disease which may progressively damage the kidney and other organs –

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN)

ULTOMIRIS® (ravulizumab)

https://www.ultomiris.com/

Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

https://alexion.com/our-research/pipeline

please visit www.alexion.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200925005244/en/

https://seekingalpha.com/symbol/ALXN

September 25, 2020 at 8:30 AM EDT

ULTOMIRIS® (ravulizumab) Receives Approval in Japan for Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Children

– ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS, reducing the treatment burden for adults and children with administration every other month –

– ULTOMIRIS has the potential to become the new standard of care in Japan for the treatment of aHUS, an ultra-rare disease which may progressively damage the kidney and other organs –

BOSTON--(BUSINESS WIRE)--Sep. 25, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)

https://ir.alexion.com/news-releases/news-release-details/ultomirisr-ravulizumab-receives-approval-japan-atypical

INDICATIONS What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat: adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). It is not known if ULTOMIRIS is safe and effective in children with PNH. It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

Jyseleca® (filgotinib)

COVID-19 vaccine candidate, JNJ-78436735

Jyseleca® (filgotinib) approved in Japan for rheumatoid arthritis

Fri September 25, 2020 2:00 AM|GlobeNewswire|About: GLPG

Filgotinib demonstrates durable efficacy and consistent safety profile through 52 weeks in clinical trials

Mechelen, Belgium; 25 September 2020, 08.00 CET – Galapagos NV (GLPGF) (Euronext & NASDAQ: GLPG) reports that Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan)

For more information, please see Gilead’s full press release on www.gilead.com.

More information at www.glpg.com.

https://seekingalpha.com/symbol/GLPG

https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/jyseleca-filgotinib-approved-in-japan-for-rheumatoid-arthritis

September 25, 2020

Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis

-- Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials --

FOSTER CITY, Calif. & TOKYO--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan)

https://seekingalpha.com/symbol/ESALF

https://www.gilead.com/science-and-medicine/pipeline

September 25, 2020 European Commission Grants Marketing Authorization for Jyseleca® ▼ (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis -- Jyseleca® Demonstrated Durable Efficacy Combined with a Consistent Safety Profile in Rheumatoid Arthritis Through 52 Weeks in Phase 3 Clinical Development Program -- FOSTER CITY, Calif., & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG)

COVID-19 vaccine candidate, JNJ-78436735

U.S.

COVID-19 Vaccine Has 98 Percent Success Rate in Johnson & Johnson Early Trial

BY JEFFERY MARTIN ON 9/25/20 AT 6:08 PM EDT

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S)

Interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735) was posted today on the pre-print server medRxiv.

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.

https://www.jnj.com/johnson-johnson-posts-interim-results-from-phase-1-2a-clinical-trial-of-its-janssen-covid-19-vaccine-candidate

Based on these findings, the single dose of the Janssen COVID-19 vaccine candidate of 5x1010 virus particles (vp) has been selected for further evaluation in the Phase 3 ENSEMBLE clinical trial.

https://www.jnj.com/

J&J COVID-19 vaccine sees strong immune response in early trial

Sep. 25, 2020 4:26 PM ET|About: Johnson & Johnson (JNJ)|By: Stephen Alpher, SA News Editor

https://seekingalpha.com/news/3617450-j-and-j-covidminus-19-vaccine-sees-strong-immune-response-in-early-trial

https://seekingalpha.com/symbol/JNJ

Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.

OPDIVO® (nivolumab)

LentiGlobin, an investigational gene therapy (bb1111)

XALKORI® (crizotinib)

Opdivo (nivolumab) Significantly Improves Disease Free-Survival vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

Thu September 24, 2020 4:15 PM|Business Wire|About: BMY

In an interim analysis, CheckMate -274 met primary endpoints of disease-free survival in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1%

Opdivo has now demonstrated clinically meaningful efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

For more information about Bristol Myers Squibb, visit us at BMS.com

Phase 3 clinical trial, CheckMate-274, evaluating Bristol Myers Squibb's (NYSE:BMY) PD-1 inhibitor Opdivo (nivolumab) after surgery (adjuvant therapy) in patients with high-risk, muscle-invasive urothelial carcinoma demonstrated that the study met the primary endpoint of disease-free survival (DFS) compared to placebo in the overall study group and in patients with PD-L1-expressing (at least 1%) cancer.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200924005649/en/

https://news.bms.com/news/corporate-financial/2020/Opdivo-nivolumab-Significantly-Improves-Disease-Free-Survival-vs.-Placebo-as-Adjuvant-Therapy-for-Patients-with-High-Risk-Muscle-Invasive-Urothelial-Carcinoma-in-Phase-3-CheckMate--274-Trial/default.aspx

Opdivo (nivolumab) Significantly Improves Disease Free-Survival vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

09/24/2020CATEGORY:

Corporate/Financial News

In an interim analysis, CheckMate -274 met primary endpoints of disease-free survival in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1%

Opdivo has now demonstrated clinically meaningful efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

XALKORI® (crizotinib)

LentiGlobin, an investigational gene therapy (bb1111)

XALKORI® (crizotinib)

FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI® (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma

Wed September 23, 2020 7:00 AM|Business Wire|About: PFE

If approved, XALKORI would be the first biomarker-driven therapy for Pediatric ALK-positive Anaplastic Large Cell Lymphoma

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

to learn more, please visit us on www.pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200923005291/en/

https://www.xalkori.com/

Indications XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.

LentiGlobin, an investigational gene therapy (bb1111)

bluebird bio’s LentiGlobin™ for Sickle Cell Disease Gene Therapy (bb1111) Granted Priority Medicines (PRIME) Designation by European Medicines Agency

Wed September 23, 2020 5:00 AM|Business Wire|About: BLUE

EMA’s PRIME program designed to optimize development and expedite evaluation of innovative medicines for patients with high unmet need

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE)

For more information visit: www.bluebirdbio.com/our-science/clinical-trials

For more information, visit bluebirdbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200923005197/en/

https://seekingalpha.com/symbol/BLUE

https://www.bluebirdbio.com/our-science/pipeline

product candidates

COVID-19 Vaccine Candidate

cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®)

LentiGlobin, an investigational gene therapy (bb1111)

Sinovac Commences Phase III Clinical Trials for COVID-19 Vaccine Candidate in Turkey

Tue September 22, 2020 8:00 AM|Business Wire|About: SVA

BEIJING--(BUSINESS WIRE)-- Sinovac Biotech Ltd. (SVA)

For more information please see the Company’s website at www.sinovac.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200922005546/en/

https://seekingalpha.com/symbol/SVA

Sinovac Commences Phase III Clinical Trials for COVID-19 Vaccine Candidate in Turkey Date: 2020-09-22 Pageview: 4426 September 22, 2020 08:00 AM Eastern Daylight Time BEIJING--Sinovac Biotech Ltd. (NASDAQ: SVA)

CTX001™ for the Treatment of Sickle Cell Disease

cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®)

CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease

Tue September 22, 2020 9:00 AM|GlobeNewswire|About: CRSP, VRTX

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (CRSP) (Nasdaq: CRSP) and Vertex (VRTX) Pharmaceuticals Incor porated (Nasdaq: VRTX)

http://www.crisprtx.com/programs/pipeline

CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)

https://news.vrtx.com/press-release/crispr-therapeutics-and-vertex-pharmaceuticals-announce-priority-medicines-prime

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex. CTX001 is the most advanced gene-editing approach in development for TDT and SCD.

For more information, please visit www.crisprtx.com.

visit www.vrtx.com

https://seekingalpha.com/news/3616127-crispr-vertex-gene-therapy-nabs-accelerated-review-in-europe-for-sickle-cell

https://seekingalpha.com/symbol/CRSP

https://seekingalpha.com/symbol/VRTX

Description: CTX001 is an autologous CRISPR/Cas9 gene-edited hematopoietic stem cell therapy in development for patients suffering from β-thalassemia and sickle cell disease Gene editing approach: Disruption Ownership: Co-development and co-commercialization with Vertex

cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®)

Exelixis Announces Results From Two Renal Cell Carcinoma Cohorts of the COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab

Mon September 21, 2020 10:20 AM|Business Wire|About: EXEL

– Cabozantinib in combination with atezolizumab demonstrated promising preliminary efficacy and a favorable safety profile in cohorts of patients with clear cell and non-clear cell renal cell carcinoma –

– Data presented during the European Society for Medical Oncology Virtual Congress 2020 –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

https://www.exelixis.com/

More information about COSMIC-021 is available at ClinicalTrials.gov (NCT03170960).

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

For more information about Exelixis, please visit www.exelixis.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200921005167/en/

https://www.exelixis.com/cabozantinib-development-program/

Exelixis Announces Results From Two Renal Cell Carcinoma Cohorts of the COSMIC-021 Trial of Cabozantinib in Combination With AtezolizumabPDF Version

– Data presented during the European Society for Medical Oncology Virtual Congress 2020 –

ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 21, 2020-- Exelixis, Inc. (NASDAQ: EXEL) today announced positive phase 1b clinical trial results for the combination of cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®)

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-results-two-renal-cell-carcinoma-cohorts

https://seekingalpha.com/symbol/EXEL

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat people with:

Advanced kidney cancer (renal cell carcinoma)
Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

https://www.cabometyx.com/

https://www.tecentriq.com/

https://www.gene.com/

Cabozantinib Development Program Discovered by Exelixis, and the focus of our development and commercialization efforts, Cabozantinib inhibits the activity of tyrosine kinases including MET, AXL, VEGF receptors, and RET and is recognized for its potential to treat a wide variety of cancers.

biotecMAX™ September/August/July 2020 insight

idecabtagene vicleucel (ide-cel; bb2121)

KEYTRUDA® (pembrolizumab) Plus Chemotherapy

idecabtagene vicleucel (ide-cel; bb2121)

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)

Tue September 22, 2020 6:59 AM|Business Wire|About: BLUE, BMY

FDA set a target action date of March 27, 2021

Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

For more information about Bristol Myers Squibb, visit us at BMS.com

For more information, visit bluebirdbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200922005376/en/

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)

09/22/2020CATEGORY:

Corporate/Financial News

FDA set a target action date of March 27, 2021

Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

https://news.bms.com/news/corporate-financial/2020/U.S.-Food-and-Drug-Administration-FDA-Accepts-for-Priority-Review-Bristol-Myers-Squibb-and-bluebird-bio-Application-for-Anti-BCMA-CAR-T-Cell-Therapy-Idecabtagene-Vicleucel-Ide-cel-bb2121/default.aspx

https://seekingalpha.com/symbol/BLUE

https://www.bluebirdbio.com/our-science/pipeline

product candidates

Opdivo (nivolumab) Plus Chemotherapy

KEYTRUDA® (pembrolizumab) Plus Chemotherapy

idecabtagene vicleucel (ide-cel; bb2121)

Opdivo (nivolumab) Plus Chemotherapy Demonstrated Significant Overall and Progression-Free Survival Benefits Versus Chemotherapy in First-Line Treatment of Gastric and Esophageal Cancers

09/21/2020CATEGORY:

Corporate/Financial News

Overall survival and progression-free survival benefit observed in patients whose tumors express PD-L1; overall survival benefit also observed in all-randomized population

Efficacy benefit observed across patients with gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma

Primary results from Phase 3 CheckMate -649 trial featured in official Press Programme and selected for presentation during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

Bristol Myers' Opdivo shows treatment benefit in stomach and esophageal cancers

Sep. 21, 2020 1:43 PM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3615829-bristol-myers-opdivo-shows-treatment-benefit-in-stomach-and-esophageal-cancers

Phase 3 CheckMate-649 assessed the combination of Opdivo and chemo in patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma in a first-line setting

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer

ADVANCED LUNG CANCER

NON-SMALL CELL LUNG CANCER

SMALL CELL LUNG CANCER

OPDIVO for people who have had prior treatments for small cell lung cancer

Choose your condition:

Advanced Lung Cancer
Advanced Kidney Cancer
Advanced Liver Cancer
Colorectal Cancer (MSI-H/dMMR)
Advanced Esophageal Squamous Cell Cancer
Melanoma
Head and Neck Squamous Cell Cancer
Advanced Bladder Cancer
Classical Hodgkin Lymphoma

https://clinicaltrials.gov/ct2/show/NCT02872116?term=checkmate-649&draw=2&rank=1.

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

https://www.keytruda.com/

https://www.bms.com/

KEYTRUDA® (pembrolizumab) Plus Chemotherapy

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Reduced Risk of Death by 27% Versus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Esophageal Cancer

Mon September 21, 2020 12:30 PM|Business Wire|About: MRK

KEYTRUDA Plus Chemotherapy Demonstrated Superior Overall Survival and Progression-Free Survival Versus Chemotherapy in These Patients Regardless of PD-L1 Expression Status and Tumor Histology

Results From Pivotal KEYNOTE-590 Trial Presented for the First Time at ESMO Virtual Congress 2020 During Presidential Symposium

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

KEYNOTE-590 is a Phase 3, randomized, double-blind trial (ClinicalTrials.gov, NCT03189719) that enrolled 749 patients and is evaluating KEYTRUDA in combination with chemotherapy, versus placebo plus chemotherapy (cisplatin plus 5-FU), for the first-line treatment of patients with locally advanced or metastatic esophageal carcinoma (including esophageal squamous cell carcinoma [ESCC] and adenocarcinoma of the esophagus) or Siewert type 1 GEJ. The primary endpoints are OS in patients with ESCC whose tumors expressed PD-L1 (CPS ≥10) and OS and PFS in patients with ESCC, in all randomized patients whose tumors expressed PD-L1 (CPS ≥10), and in all randomized patients.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

For more information, visit www.merck.com

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER

IT’S TRU. KEYTRUDA.

SELECT A TYPE OF CANCER

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Reduced Risk of Death by 27% Versus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Esophageal Cancer

https://www.merck.com/news/mercks-keytruda-pembrolizumab-plus-chemotherapy-reduced-risk-of-death-by-27-versus-chemotherapy-as-first-line-treatment-for-locally-advanced-or-metastatic-esophageal-cancer/

https://www.merck.com/

Phase 3 clinical trial, KEYNOTE-590,

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER IT’S TRU. KEYTRUDA. SELECT A TYPE OF CANCER Search by cancer type or name Advanced non–small cell lung cancer Melanoma Head and neck squamous cell cancer High-risk non-muscle invasive bladder cancer (NMIBC) Advanced urothelial bladder cancer Advanced kidney cancer (RCC) Microsatellite instability-high cancer Classical Hodgkin lymphoma Advanced gastric cancer Advanced cervical cancer Primary mediastinal B‑cell lymphoma Advanced liver cancer (HCC) Advanced Merkel cell carcinoma Advanced esophageal squamous cell carcinoma

tisotumab vedotin

MitraClip G4 to treat mitral regurgitation

KEYTRUDA® (pembrolizumab) Plus Chemotherapy

Seattle Genetics and Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

Mon September 21, 2020 10:20 AM|Business Wire|About: GMAB, SGEN

- Data Featured in Late-Breaking Proffered Paper Oral Presentation -

- Biologics License Application Submission Planned to Support Accelerated Approval Pathway with the FDA -

BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Genmab A/S (GNMSF) (Nasdaq: GMAB)

tisotumab vedotin

https://www.seattlegenetics.com/pipeline/tisotumab-vedotin

https://www.seattlegenetics.com/

phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin

For more information on our robust pipeline, visit www.seattlegenetics.com

www.genmab.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200921005214/en/

Seattle Genetics and Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

09/21/2020

- Data Featured in Late-Breaking Proffered Paper Oral Presentation -

- Biologics License Application Submission Planned to Support Accelerated Approval Pathway with the FDA -

BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (Nasdaq: GMAB)

https://investor.seattlegenetics.com/press-releases/news-details/2020/Seattle-Genetics-and-Genmab-Present-Data-from-Tisotumab-Vedotin-innovaTV-204-Pivotal-Trial-in-Recurrent-or-Metastatic-Cervical-Cancer-at-ESMO-Virtual-Congress-2020/default.aspx

https://seekingalpha.com/symbol/GMAB

https://seekingalpha.com/symbol/SGEN

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human antibody targeted to tissue factor (TF) and our ADC technology that utilizes a protease-cleavable linker and the potent microtubule-disrupting agent monomethyl auristatin E (MMAE). TF is highly expressed on many solid tumors, including ovarian, prostate, bladder, esophageal, endometrial and lung. We are co-developing tisotumab vedotin with Genmab.

ZEJULA® (niraparib)

MitraClip G4 to treat mitral regurgitation

https://seekingalpha.com/pr/18012703-phase-3-nora-data-of-zejula-niraparib-demonstrate-significant-pfs-benefit-regardless-of

ZEJULA® (niraparib)

https://www.zejula.com/en

For additional information about the Company, please visit www.zailaboratory.com

Zai Lab has a collaboration, development and license agreement with GSK for the development and commercialization of ZEJULA in Mainland China, Hong Kong and Macau.

Zai Lab has a broad and validated late-stage pipeline in oncology and infectious disease. We currently have 2 products commercialized and 4 drugs approved in the U.S. (marked with * below). Overall, our pipeline consists of over 15 drug candidates with over 20 ongoing or planned clinical trials.

http://www.zailaboratory.com/pipeline/list.aspx

https://seekingalpha.com/symbol/ZLAB

https://zailab.gcs-web.com/news-releases/news-release-details/phase-3-nora-data-zejular-niraparib-demonstrate-significant-pfs

Phase 3 NORA data of ZEJULA® (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian cancer

September 19, 2020 at 7:30 AM EDTPDF Version

The NORA study, presented as a late-breaker oral presentation at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress, demonstrates that niraparib maintenance treatment resulted in a 68% reduction in the risk of disease progression or death in the overall study population when compared to placebo.
An individualized starting dose regimen based on patient’s baseline weight and/or platelet count shown to be effective; lower rates of hematological adverse events were observed with the individualized dosing group.

SHANGHAI and SAN FRANCISCO, Sept. 19, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB)

MitraClip G4 to treat mitral regurgitation

ABBOTT RECEIVES CE MARK FOR NEXT-GENERATION MITRACLIP™ HEART VALVE REPAIR DEVICE TO TREAT MITRAL REGURGITATION- CE Mark for MitraClip G4 offers physicians an innovative next-generation system with more options for mitral valve repair using proven clip-based technology- MitraClip is a first-of-its-kind transcatheter mitral valve therapy, now on its fourth generation, improving further on MitraClip's history as a safe and effective treatment option

ABBOTT PARK, Ill., Sept. 21, 2020 /PRNewswire/ -- Abbott (NYSE: ABT)

https://mitraclip.com/

Abbott receives CE mark approval for MitraClip G4 to treat mitral regurgitation

Sep. 21, 2020 9:39 AM ET|By: Meghavi Singh, SA News Editor

https://seekingalpha.com/news/3615693-abbott-receives-ce-mark-approval-for-mitraclip-g4-to-treat-mitral-regurgitation

https://seekingalpha.com/symbol/ABT

MITRACLIP NOW HELPS MANY MORE

https://www.abbott.com/corpnewsroom/product-and-innovation/mitraclip-now-helps-many-more-with-smr.html

https://seekingalpha.com/symbol/ABT

DON'T WAIT TO DO SOMETHING ABOUT MITRAL REGURGITATION—THERE ARE OPTIONS Mitral regurgitation, which is caused by a leaky heart valve, can place serious burdens on your quality of life. If your doctor has told you that you’re not a candidate for surgery, you may be eligible for a less-invasive treatment option. Learn more about mitral regurgitation treatment options and how the MitraClip procedure may help you.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020

Sun September 20, 2020 8:25 AM|Business Wire|About: MRK

New Results Include Findings From the Phase 2 LEAP-004 Trial Showing an ORR of 21.4% in Patients With Unresectable or Advanced Melanoma Who Had Previously Progressed on an Anti-PD-1/PD-L1 Therapy

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, and Eisai

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200920005060/en/

LEAP-004 (ClinicalTrials.gov, NCT03776136) is a Phase 2, single-arm, open-label trial evaluating KEYTRUDA in combination with LENVIMA in patients with unresectable or advanced melanoma who had progressed on an anti-PD-1/PD-L1 therapy within 12 weeks.

LEAP-005 (ClinicalTrials.gov, NCT03797326) is a Phase 2, single-arm, open-label trial evaluating KEYTRUDA in combination with LENVIMA in patients with select previously treated advanced solid tumors.

Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.

For more information, visit www.merck.com

For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.eu (for Europe, Middle East, Africa)

http://www.lenvima.com/

https://www.keytruda.com/

https://seekingalpha.com/symbol/ESALY

Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020

https://www.merck.com/news/merck-and-eisai-present-first-time-data-from-two-studies-evaluating-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-seven-different-tumor-types-at-esmo-virtual-congress-2020/

What is LENVIMA? LENVIMA is a prescription medicine that is used to treat certain kinds of cancer. LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing LENVIMA is used along with another medicine called everolimus to treat advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anti-cancer medicine LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery It is not known if LENVIMA is safe and effective in children.

TRODELVY™ (sacituzumab govitecan-hziy)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

Trodelvy™ Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer

Sat September 19, 2020 10:30 AM|GlobeNewswire|About: IMMU

Trodelvy significantly reduced the risk of death by 52 percent, with a median overall survival (OS) of 12.1 months compared to 6.7 months for standard single-agent chemotherapy

Trodelvy is the first ADC to significantly improve OS in metastatic triple-negative breast cancer (mTNBC)

sBLA for full approval to be submitted in fourth quarter 2020 under RTOR process

Company to host conference call and webcast today at 2:00 p.m. Eastern Time

MORRIS PLAINS, N.J., Sept. 19, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU) (NASDAQ: IMMU)

More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

Visit https://www.trodelvy.com/ for more information.

please visit its website at https://immunomedics.com/

Boldly developing next-generation antibody-drug conjugate therapies

https://immunomedics.com/our-science

TrodelvyTM Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer

Sept.19, 2020
Morris Plains, N.J.,
NASDAQ: IMMU

https://immunomedics.com/news-and-events/Trodelvy-significantly-extends-survival-in-phase3-ASCENT-study-of-Metastatic-Triple-Negative-Breast-Cancer

https://seekingalpha.com/symbol/IMMU

INDICATION TRODELVY™ (sacituzumab govitecan-hziy) is indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib)

Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Distant Metastasis or Death by 40% Versus Placebo as Adjuvant Treatment in Resected, High-Risk Stage III Melanoma

Sat September 19, 2020 10:20 AM|Business Wire|About: MRK

Long-Term Findings From EORTC1325/KEYNOTE-054 Show Adjuvant KEYTRUDA Demonstrated a Sustained Recurrence-Free Survival Benefit Versus Placebo Across Stage IIIA (>1 mm Lymph Node Metastasis), IIIB and IIIC Melanoma

Merck (MRK) Is Advancing a Broad Clinical Program Evaluating KEYTRUDA for the Early Treatment of Cancer

KENILWORTH, N.J., & BRUSSELS--(BUSINESS WIRE)-- Merck,

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200919005015/en/

EORTC1325/KEYNOTE-054 (ClinicalTrials.gov, NCT02362594) is a Phase 3, randomized, double-blind study

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

For more information, visit www.merck.com

Phase 3 EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma.

https://www.merck.com/news/mercks-keytruda-pembrolizumab-reduced-the-risk-of-distant-metastasis-or-death-by-40-versus-placebo-as-adjuvant-treatment-in-resected-high-risk-stage-iii-melanoma/

Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Distant Metastasis or Death by 40% Versus Placebo as Adjuvant Treatment in Resected, High-Risk Stage III Melanoma

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER

IT’S TRU. KEYTRUDA.

SELECT A TYPE OF CANCER

https://www.keytruda.com/

Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib)

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial

Sat September 19, 2020 12:30 PM|Business Wire|About: BMY, EXEL

Opdivo in combination with CABOMETYX showed superior overall survival and doubled median progression-free survival and objective response rate with a favorable safety profile vs. sunitinib

Efficacy benefits were observed across key patient subgroups, including all International Metastatic Renal Cell Carcinoma Database Consortium risk and PD-L1 subgroups

Data selected for presentation during a Presidential Symposium and featured in official Press Programme at European Society for Medical Oncology Virtual Congress 2020

PRINCETON, N.J., & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

Please see accompanying full Prescribing Information: https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

For more information about Exelixis, please visit www.exelixis.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200919005012/en/

Phase 3 CheckMate -9ER trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

https://seekingalpha.com/symbol/EXEL

https://www.cabometyx.com/

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat people with:

Advanced kidney cancer (renal cell carcinoma)
Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer

ADVANCED LUNG CANCER

NON-SMALL CELL LUNG CANCER

SMALL CELL LUNG CANCER

OPDIVO for people who have had prior treatments for small cell lung cancer

Choose your condition:

Advanced Lung Cancer
Advanced Kidney Cancer
Advanced Liver Cancer
Colorectal Cancer (MSI-H/dMMR)
Advanced Esophageal Squamous Cell Cancer
Melanoma
Head and Neck Squamous Cell Cancer
Advanced Bladder Cancer
Classical Hodgkin Lymphoma

https://seekingalpha.com/news/3615604-bmy-exelixis-opdivo-cabometyx-shows-survival-benefits-in-late-stage-kidney-cancer-study

BMY/Exelixis Opdivo + Cabometyx shows survival benefits in late-stage kidney cancer study

Sep. 21, 2020 7:22 AM ET|About: Bristol-Myers Squibb Company (BMY)|By: Mamta Mayani, SA News Editor

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial PDF Version Opdivo in combination with CABOMETYX showed superior overall survival and doubled median progression-free survival and objective response rate with a favorable safety profile vs. sunitinib Efficacy benefits were observed across key patient subgroups, including all International Metastatic Renal Cell Carcinoma Database Consortium risk and PD-L1 subgroups Data selected for presentation during a Presidential Symposium and featured in official Press Programme at European Society for Medical Oncology Virtual Congress 2020 PRINCETON, N.J., & ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 19, 2020-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL)

TAGRISSO® (osimertinib)

Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib)

TAGRISSO® (osimertinib)

TAGRISSO Reduced the Risk of Disease Recurrence in the Brain by 82% in the Adjuvant Treatment of Early-Stage EGFR-Mutated Lung Cancer

Sat September 19, 2020 1:04 PM|Business Wire|About: AZN

ADAURA Phase III trial data at ESMO reinforce the proven clinical activity of TAGRISSO in treating central nervous system metastases

WILMINGTON, Del.--(BUSINESS WIRE)-

Results were presented on September 19, 2020 during the Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (abstract #LBA1) and simultaneously published with the primary results in The New England Journal of Medicine.

Please see complete Prescribing Information, including Patient Information.

For more information, please visit www.astrazeneca-us.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200919005021/en/

Tagrisso reduced the risk of disease recurrence in the brain by 82% in the adjuvant treatment of early-stage EGFR-mutated lung cancer

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tagrisso-reduces-brain-recurrence-in-early-lung.html

https://www.tagrisso.com/

What is TAGRISSO? TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used: as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s) or if you have a certain type of EGFR gene and were previously treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working Your doctor will perform a test to make sure that TAGRISSO is right for you.

LYNPARZA® (olaparib)

Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib)

TAGRISSO® (osimertinib)

LYNPARZA® (olaparib)

https://www.lynparza.com/

LYNPARZA® (olaparib) Reduced the Risk of Death by 31% in BRCA1/2 or ATM-mutated Metastatic Castration-Resistant Prostate Cancer in Phase III Profound Trial

Sun September 20, 2020 12:30 PM|Business Wire|About: AZN, MRK

LYNPARZA is the only PARP inhibitor to demonstrate overall survival in metastatic castration-resistant prostate cancer

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK),

Please visit www.astrazeneca-us.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200920005055/en/

Lynparza reduced the risk of death by 31% in BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in PROfound Phase III trial

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-reduced-the-risk-of-death-by-31-percent-in-brca-or-atm-mcrpc-in-profound.html

21 September 2020 07:05 BST

Lynparza recommended for approval in EU by CHMP as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-eu-recommendation-in-ovarian-cancer.html

Lynparza recommended for approval in the EU by CHMP for BRCA-mutated metastatic castration-resistant prostate cancer

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-eu-recommendation-in-prostate-cancer.html

AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK) announce final results from the Phase III PROfound trial that showed LYNPARZA (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus enzalutamide or abiraterone in men with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 or ATM gene mutations.

WHAT IS LYNPARZA? LYNPARZA is a prescription medicine used to treat adults who have: advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you

biotecMAX™ September/August/July 2020 insight

Libtayo® (cemiplimab)

TYVYT (sintilimab injection)

Late-breaking ESMO presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

Sun September 20, 2020 8:25 PM|GlobeNewswire|About: SNY

Late-breaking ESMO presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

In the overall trial population, Libtayo reduced risk of death by 32% compared to chemotherapy
In a prespecified analysis of patients with confirmed PD-L1 expression of ≥50%, Libtayo reduced risk of death by 43%

PARIS and TARRYTOWN, N.Y. – September 21, 2020

For additional information about the company, please visit www.regeneron.com

September 21, 2020 at 8:25 AM EDT Back

LATE-BREAKING ESMO PRESENTATION SHOWS LIBTAYO® (CEMIPLIMAB) MONOTHERAPY INCREASES OVERALL SURVIVAL IN FIRST-LINE ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%

TARRYTOWN, N.Y. and PARIS, Sept. 21, 2020 /PRNewswire/ --

- In the overall trial population, Libtayo reduced risk of death by 32% compared to chemotherapy

- In a prespecified analysis of patients with confirmed PD-L1 expression of ≥50%, Libtayo reduced risk of death by 43%

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi

https://investor.regeneron.com/news-releases/news-release-details/late-breaking-esmo-presentation-shows-libtayor-cemiplimab

https://www.libtayo.com/

https://seekingalpha.com/symbol/SNY

LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

TYVYT (sintilimab injection)

Lilly, Innovent ORIENT-11 combo study show improved efficacy in lung cancer

Sep. 21, 2020 12:11 AM ET|About: Eli Lilly and Company (LLY)|By: Mamta Mayani, SA News Editor

Phase 3 results from the ORIENT-11 study evaluating TYVYT (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements.

Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Recurrent Non-squamous NSCLC

https://clinicaltrials.gov/ct2/show/NCT03607539?term=NCT03607539&draw=2&rank=1

Eli Lilly (NYSE:LLY) and Innovent Biologics (OTCPK:IVBIY)

http://innoventbio.com/en/#/

http://innoventbio.com/en/#/pline

Innovent and Lilly Release Biomarker Results of TYVYT® (Sintilimab Injection) in Combination with ALIMTA® (Pemetrexed) and Platinum Chemotherapy as First-Line Treatment for Nonsquamous Non-Small Cell Lung Cancer at ESMO Virtual Congress 2020

Publish at：Sep 21 2020

SAN FRANCISCO, U.S. and SUZHOU, China, September 21, 2020 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801

http://innoventbio.com/en/#/news/212

ROBUST PIPELINE ACROSS NOVEL THERAPEUTICS AND BIOSIMILARS

Verzenio® (abemaciclib)

TYVYT (sintilimab injection)

Zavicefta (ceftazidime/avibactam)

Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer

Sun September 20, 2020 2:01 PM|PR Newswire|About: LLY

The Phase 3 monarchE trial evaluating the effects of two years of Verzenio treatment added to endocrine therapy achieved the primary endpoint of IDFS, demonstrating definitive and clinically meaningful results among people whose breast cancer is at a high risk of recurrence

Data presented in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress and simultaneously published in the Journal of Clinical Oncology (JCO)

PR Newswire

INDIANAPOLIS, Sept. 20, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)

Please see full Prescribing Information for Verzenio.

Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer

September 20, 2020

https://investor.lilly.com/news-releases/news-release-details/verzenior-significantly-reduced-risk-cancer-recurrence-25-people

https://www.verzenio.com/

Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer

https://www.prnewswire.com/news-releases/verzenio-significantly-reduced-the-risk-of-cancer-recurrence-by-25-for-people-with-hr-her2--high-risk-early-breast-cancer-301134339.html

Verzenio is a prescription oral medicine used to treat a type of breast cancer. It is a medicine you can take if you have a type of breast cancer called HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2–negative) and the cancer has spread to other parts of the body (metastasized). Verzenio is given in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, in combination with fulvestrant in women whose disease has progressed after hormonal therapy, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy.

Zavicefta (ceftazidime/avibactam)

Tecentriq (atezolizumab), combined with Avastin (bevacizumab)

Zavicefta (ceftazidime/avibactam)

European advisory group backs new use of Pfizer combo antibiotic

Sep. 18, 2020 10:30 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

On 25 June 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zavicefta. The marketing authorisation holder for this medicinal product is Pfizer Ireland Pharmaceuticals.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/zavicefta

https://www.pfizer.com/

ZAVICEFTA®▼ (CEFTAZIDIME AND AVIBACTAM)

Zavicefta is an antibiotic medicine, launched in the UK in 2017.

https://www.pfizer.co.uk/prescription-medicines/zavicefta

ZAVICEFTA®▼ (CEFTAZIDIME AND AVIBACTAM)

Zejula (niraparib)

Tecentriq (atezolizumab), combined with Avastin (bevacizumab)

European advisory group backs expanded use of Glaxo's Zejula

Sep. 18, 2020 10:22 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zejula. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/zejula

https://www.zejula.com/en

https://www.gsk.com/en-gb/home/

18 September 2020

GSK receives CHMP positive opinion recommending approval of Zejula (niraparib) as first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer

For media and investors only

Issued: London, UK

GlaxoSmithKline (GSK)

https://www.gsk.com/en-gb/media/press-releases/gsk-receives-chmp-positive-opinion-recommending-approval-of-zejula-niraparib-as-first-line-monotherapy-maintenance-treatment-for-women-with-platinum-responsive-advanced-ovarian-cancer/

Tecentriq (atezolizumab), combined with Avastin (bevacizumab)

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tecentriq. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

European advisory group backs Roche's Tecentriq in first-line liver cancer

Sep. 18, 2020 9:46 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3615348-european-advisory-group-backs-roches-tecentriq-in-first-line-liver-cancer

Tecentriq (atezolizumab), combined with Avastin (bevacizumab)

https://www.tecentriq.com/

https://seekingalpha.com/symbol/RHHBY

Indications

Stage III or IV ovarian cancer (OC) after primary surgery
Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (rOC)
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Persistent, recurrent, or metastatic cervical cancer (CC)
Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

Metastatic renal cell carcinoma (mRCC)
Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.

Recurrent glioblastoma (GBM)
Avastin is indicated for the treatment of recurrent glioblastoma in adults.

First-line non-squamous non-small cell lung cancer (NSCLC)
Avastin, in combination with carboplatin and paclitaxel, is indicated for the first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.

Metastatic colorectal cancer (MCRC)
Avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first‑ or second‑line treatment of patients with metastatic colorectal cancer.

https://www.avastin.com/hcp.html

Indications TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. TECENTRIQ may be used when your bladder cancer: has spread or cannot be removed by surgery, and if you have any one of the following conditions: you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for "PD-L1", or you are not able to take chemotherapy that contains any platinum regardless of "PD-L1" status, or you have tried chemotherapy that contains platinum, and it did not work or is no longer working. The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit. A type of lung cancer called non-small cell lung cancer (NSCLC). TECENTRIQ may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. TECENTRIQ may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. TECENTRIQ may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. TECENTRIQ may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. A type of breast cancer called triple-negative breast cancer (TNBC). TECENTRIQ may be used with the medicine paclitaxel protein-bound when your breast cancer: has spread or cannot be removed by surgery, and your cancer tests positive for “PD-L1.” The approval of TECENTRIQ in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit. A type of lung cancer called small cell lung cancer (SCLC). TECENTRIQ may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer: is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown. A type of liver cancer called hepatocellular carcinoma (HCC). TECENTRIQ may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. A type of skin cancer called melanoma. TECENTRIQ may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this TECENTRIQ combination is right for you.

investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intra

Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress

Fri September 18, 2020 6:30 AM|PR Newswire|About: ALKS

- Monotherapy Melanoma Cohort Expanded Based on Achievement of Protocol-Defined Response Criteria -

- Company to Host Investor Webcast at 8:30 a.m. ET on Friday, Sept. 18, 2020 -

PR Newswire

DUBLIN, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)

ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®).

please visit Alkermes' website at www.alkermes.com.

https://www.prnewswire.com/news-releases/alkermes-presents-new-clinical-data-on-alks-4230-in-mini-oral-presentation-at-2020-european-society-for-medical-oncology-esmo-virtual-congress-301133701.html

https://seekingalpha.com/symbol/ALKS

Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress

- Data Provide Evidence of Clinical Benefit and Tolerability of ALKS 4230 as Monotherapy in Melanoma and in Combination With Pembrolizumab in Multiple Tumor Types -
- Monotherapy Melanoma Cohort Expanded Based on Achievement of Protocol-Defined Response Criteria -
- Company to Host Investor Webcast at 8:30 a.m. ET on Friday, Sept. 18, 2020 -

DUBLIN, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

https://investor.alkermes.com/news-releases/news-release-details/alkermes-presents-new-clinical-data-alks-4230-mini-oral

Pipeline of Key Proprietary Products We have a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer.

Retifanlimab (INCMGA0012)

investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intra

Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal

Fri September 18, 2020 6:00 AM|Business Wire|About: INCY

Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
Presentation is available on-demand as part of the ESMO Virtual Congress 2020
POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

Retifanlimab (INCMGA0012)

For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT04472429.

please visit Incyte.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200918005082/en/

Phase 2 clinical trial, PODIUM-202,

https://seekingalpha.com/symbol/INCY

Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal

18 September, 2020

PDF Version

Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
Presentation is available on-demand as part of the ESMO Virtual Congress 2020
POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 18, 2020-- Incyte (Nasdaq:INCY)

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-encouraging-results-phase-2-trial-retifanlimab

DISCOVERY & DEVELOPMENT Incyte’s drug discovery efforts were founded in 2002 by a team of world-class scientists striving to create innovative medicines for patients. The relentless pursuit of scientific excellence remains at the core of our company today.

Tislelizumab (BGB-A317)

investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intra

Tislelizumab (BGB-A317)

BeiGene Presents Data at ESMO Virtual Congress 2020 on Phase 3 Trial of Tislelizumab in First-Line Non-Squamous Non-Small Cell Lung Cancer and Phase 2 Trial of Pamiparib in Advanced Ovarian Cancer

Thu September 17, 2020 6:05 PM|Business Wire|About: BGNE

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene, Ltd. (BGNE)

Phase 2 trial of its investigational PARP inhibitor pamiparib in advanced ovarian cancer (OC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Tislelizumab (BGB-A317)

https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab

lease visit www.beigene.com

https://seekingalpha.com/symbol/BGNE

View source version on businesswire.com: https://www.businesswire.com/news/home/20200917005874/en/

BeiGene Presents Data at ESMO Virtual Congress 2020 on Phase 3 Trial of Tislelizumab in First-Line Non-Squamous Non-Small Cell Lung Cancer and Phase 2 Trial of Pamiparib in Advanced Ovarian Cancer

September 17, 2020 at 6:05 PM EDT

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--Sep. 17, 2020-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),

http://ir.beigene.com/news-releases/news-release-details/beigene-presents-data-esmo-virtual-congress-2020-phase-3-trial?loc=US

Tislelizumab Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody

LYNPARZA® (olaparib)

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy

Tislelizumab (BGB-A317)

LYNPARZA® (olaparib) Improved Median Time Patients Lived Without Disease Progression to Over Four and Half Years in BRCA-mutated Advanced Ovarian Cancer vs. Just Over One Year With Placebo

Fri September 18, 2020 7:00 AM|Business Wire|About: AZN

Five-year data from the SOLO-1 Phase III trial is the longest follow-up analysis for any PARP inhibitor in the 1st-line maintenance setting

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada)

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

Please visit www.astrazeneca-us.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200918005089/en/

https://www.lynparza.com/

LYNPARZA® (olaparib) improved median time patients lived without disease progression to over four and half years in BRCA-mutated advanced ovarian cancer vs. just over one year with placebo

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/lynparza-olaparib-improved-median-time-patients-lived-without-disease-progression-to-over-four-and-half-years-in-brca-mutated-advanced-ovarian-cancer-vs-just-over-one-year-with-placebo-09182020.html

https://www.astrazeneca-us.com/

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer

Fri September 18, 2020 7:17 AM|Business Wire|About: BMY

Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival in previously untreated patients with metastatic non-small cell lung cancer

Clinical benefit with Opdivo plus Yervoy with limited chemotherapy observed vs. chemotherapy across all PD-L1 expression levels and histologies

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://www.bms.com/

The full data from the CheckMate -9LA trial were featured in an oral session at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200918005259/en/

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer

09/18/2020CATEGORY:

Corporate/Financial News

Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival in previously untreated patients with metastatic non-small cell lung cancer

Clinical benefit with Opdivo plus Yervoy with limited chemotherapy observed vs. chemotherapy across all PD-L1 expression levels and histologies

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Receives-Positive-CHMP-Opinion-Recommending-Approval-of-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Combined-with-Two-Cycles-of-Chemotherapy-as-First-Line-Treatment-of-Metastatic-Non-Small-Cell-Lung-Cancer/default.aspx

https://www.opdivoyervoymnsclc.com/

INDICATIONS

For Patients With Metastatic Non-Small Cell Lung Cancer

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO, in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

INDICATIONS For Patients With Metastatic Non-Small Cell Lung Cancer OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO, in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

PADCEV® (enfortumab vedotin-ejfv)

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy

Astellas and Seattle Genetics Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer

Fri September 18, 2020 6:45 AM|PR Newswire|About: ALPMY, SGEN

- Data Intended to Support Global Registrations and Convert Accelerated to Regular Approval in U.S. -

PR Newswire

TOKYO and BOTHELL, Wash., Sept. 18, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc (SGEN). (Nasdaq:SGEN)

https://www.padcev.com/hcp/

For more information about the EV-301 clinical trial, please visit www.clinicaltrials.gov.

About PADCEV® (enfortumab vedotin-ejfv)

For more information, please visit our website at https://www.astellas.com/en/

For more information on our robust pipeline, visit www.seattlegenetics.com

https://www.prnewswire.com/news-releases/astellas-and-seattle-genetics-announce-padcev-enfortumab-vedotin-ejfv-significantly-improved-overall-survival-in-phase-3-trial-in-previously-treated-locally-advanced-or-metastatic-urothelial-cancer-301133747.html

https://seekingalpha.com/symbol/ALPMF

https://seekingalpha.com/symbol/SGEN

Seattle Genetics and Astellas Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer

09/18/2020

- Trial Stopped Early Due to Positive Results at Planned Interim Analysis -

- Data Intended to Support Global Registrations and Convert Accelerated to Regular Approval in U.S. -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503,

https://investor.seattlegenetics.com/press-releases/news-details/2020/Seattle-Genetics-and-Astellas-Announce-PADCEV-enfortumab-vedotin-ejfv-Significantly-Improved-Overall-Survival-in-Phase-3-Trial-in-Previously-Treated-Locally-Advanced-or-Metastatic-Urothelial-Cancer/default.aspx

PADCEV Indication

PADCEV (enfortumab vedotin-ejfv) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

This indication is approved under accelerated approval based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

https://www.seattlegenetics.com/products/padcev

INDICATION PADCEV (enfortumab vedotin-ejfv) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. This indication is approved under accelerated approval based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMFINZI® (durvalumab)

Imfinzi demonstrated unprecedented survival in unresectable, Stage III non-small cell lung cancer with an estimated 50% of patients surviving four years

18 September 2020 08:00 BST

PACIFIC Phase III trial data at ESMO also showed an estimated 35% of non-small
cell lung cancer patients treated with Imfinzi had not progressed after four years

CASPIAN Phase III trial data also at ESMO underscored long-term benefit in a
proportion of patients with extensive-stage small cell lung cancer

https://www.astrazeneca.com/

Phase 3 clinical trial, PACIFIC, evaluating AstraZeneca's (NYSE:AZN) Imfinzi (durvalumab) in patients with unresectable Stage 3 non-small lung cancer (NSCLC) who had not progressed after concurrent chemoradiation therapy (CRT) showed a significant survival benefit. The results were presented virtually at ESMO.

https://www.imfinzi.com/

IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC). It is not known if IMFINZI is safe and effective in children.

BAVENCIO® (avelumab)

IMFINZI® (durvalumab)

BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine

Fri September 18, 2020 3:00 AM|PR Newswire|About: MKKGY, PFEPR Newswire

ROCKLAND, Mass. and NEW YORK, Sept. 18, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (PFE)

JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC.

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

www.emdserono.com.

In addition, to learn more, please visit us on www.pfizer.com

https://www.prnewswire.com/news-releases/bavencio-pivotal-phase-iii-javelin-bladder-100-results-published-in-the-new-england-journal-of-medicine-301133720.html

detailed results from the Phase III JAVELIN Bladder 100 study at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

https://seekingalpha.com/symbol/MKGAY

INDICATIONS BAVENCIO is a prescription medicine used to treat: A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working These indications are approved under accelerated approval based on clinical trials that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials. It is not known if BAVENCIO is safe and effective in children under the age of 12.

Libtayo® (cemiplimab)

IMFINZI® (durvalumab)

Libtayo® (cemiplimab)

Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO

Fri September 18, 2020 3:05 AM|GlobeNewswire|About: SNY

Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO

Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial
31% objective response rate seen in trial patients, and an estimated 85% of responses were ongoing at one year

PARIS and TARRYTOWN, N.Y. – September 18, 2020 -

For additional information about the company, please visit www.regeneron.com

September 18, 2020 at 3:05 AM EDT Back

POSITIVE PIVOTAL DATA FOR LIBTAYO® (CEMIPLIMAB) MONOTHERAPY IN LOCALLY ADVANCED BASAL CELL CARCINOMA FEATURED AS A LATE-BREAKING PRESENTATION AT ESMO

TARRYTOWN, N.Y. and PARIS, Sept. 18, 2020 /PRNewswire/ --

Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial

31% objective response rate seen in trial patients, and an estimated 85% of responses were ongoing at one year

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanof

https://investor.regeneron.com/news-releases/news-release-details/positive-pivotal-data-libtayor-cemiplimab-monotherapy-locally

https://seekingalpha.com/symbol/SNY

LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

Tivozanib (FOTIVDA®)

HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase)

Libtayo® (cemiplimab)

AVEO Oncology Announces European Urology Publication of Final Overall Survival Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

Tue September 15, 2020 4:05 PM|Business Wire|About: AVEO

BOSTON--(BUSINESS WIRE)-- AVEO Oncology (Nasdaq: AVEO)

Phase 3 TIVO-3 study comparing Fotivda (tivozanib) to Bayer's (OTCPK:BAYRY) Nexavar (sorafenib)

https://www.aveooncology.com/product-candidates/tivozanib/

AVEO Pharmaceuticals, Inc. (AVEO)

View source version on businesswire.com: https://www.businesswire.com/news/home/20200915006253/en/

AVEO Oncology Announces European Urology Publication of Final Overall Survival Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

Sep 15 | 2020Download PDF

BOSTON--(BUSINESS WIRE)--Sep. 15, 2020-- AVEO Oncology (Nasdaq: AVEO)

https://aveooncology.gcs-web.com/news-releases/news-release-details/aveo-oncology-announces-european-urology-publication-final

https://seekingalpha.com/symbol/AVEO

Aveo announces final results from late-stage study of tivozanib in kidney cancer

Sep. 15, 2020 4:52 PM ET|About: AVEO Pharmaceuticals, ... (AVEO)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3614342-aveo-announces-final-results-from-late-stage-study-of-tivozanib-in-kidney-cancer

Tivozanib (VEGFR 123 TKI) Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications1,2. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

Novavax boosts COVID-19 vaccine production capacity to 2B doses per year

HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase)

Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually

Tue September 15, 2020 7:00 AM|GlobeNewswire|About: NVAX

Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021
Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021
Agreement expands Novavax (NVAX) partnership with world’s largest vaccine developer to increase global delivery of NVX-CoV2373

GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc.,

https://www.seruminstitute.com/

Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021

For more information, visit www.novavax.com

Learn more about Serum Institute of India at https://www.seruminstitute.com/.

Sep 15, 2020

Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually

Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021 Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021 Agreement expands Novavax partnership with world’s largest vaccine developer to increase global...

Novavax boosts COVID-19 vaccine production capacity to 2B doses per year

Sep. 15, 2020 7:18 AM ET|About: Novavax, Inc. (NVAX)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3614003-novavax-boosts-covidminus-19-vaccine-production-capacity-to-2b-doses-per-year

https://seekingalpha.com/symbol/NVAX

NVX-CoV2373

HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase)

European Medicines Agency Approves Label Update for HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase), Expanding its Use to a Broader Group of Patients with Secondary Immunodeficiencies

Tue September 15, 2020 3:00 AM|Business Wire|About: TAK

OSAKA, JAPAN--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

Please consult the HYQVIA Summary of Product Characteristics (SmPC) before prescribing.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)

For more information, visit https://www.takeda.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200915005293/en/

https://seekingalpha.com/symbol/TAK

https://www.hyqvia.com/

What is HYQVIA? HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in adults.

Jardiance® (empagliflozin)

Magrolimab is a first-in-class investigational monoclonal antibody against CD47

US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack

Tue September 15, 2020 8:00 AM|PR Newswire|About: LLY

- This Fast Track designation for empagliflozin emphasizes the urgent need for potential treatments that may improve outcomes following an acute myocardial infarction, more commonly known as a heart attack, in adults with and without diabetes

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 15, 2020 /PRNewswire/ -

A Phase 3 clinical trial, EMPACT-MI, is in process.

https://www.jardiance.com/

For more information, please see Prescribing Information and Medication Guide.

For more information, please visit www.boehringer-ingelheim.us

For the latest updates, visit http://www.lillydiabetes.com/

To learn more about Lilly, please visit us at lilly.com

https://www.prnewswire.com/news-releases/us-fda-grants-fast-track-designation-to-jardiance-empagliflozin-to-improve-outcomes-following-a-heart-attack-301130575.html

US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack

September 15, 2020

https://investor.lilly.com/news-releases/news-release-details/us-fda-grants-fast-track-designation-jardiancer-empagliflozin

JARDIANCE is the first type 2 diabetes medication proven to go beyond lowering A1C to reduce the risk of cardiovascular (CV) death for adults who have type 2 diabetes and known heart disease. Results with JARDIANCE

Magrolimab is a first-in-class investigational monoclonal antibody against CD47

Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome

Tue September 15, 2020 8:00 AM|Business Wire|About: GILD

-- Ongoing Clinical Program Includes the Phase 3 ENHANCE Study in MDS --

-- Additional Studies Are Evaluating Magrolimab in Both Hematologic and Solid Tumors --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200915005434/en/

September 15, 2020 Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome -- Ongoing Clinical Program Includes the Phase 3 ENHANCE Study in MDS -- -- Additional Studies Are Evaluating Magrolimab in Both Hematologic and Solid Tumors -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)

Opdivo®(nivolumab) plus Yervoy®(ipilimumab)

Magrolimab is a first-in-class investigational monoclonal antibody against CD47

Opdivo®(nivolumab) plus Yervoy®(ipilimumab)

European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma

Tue September 15, 2020 6:59 AM|Business Wire|About: BMY

Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs

Application based on positive results from pivotal Phase 3 CheckMate -743 trial

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

Results from CheckMate -743 were presented at the 2020 World Conference on Lung Cancer Virtual Presidential Symposium

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.

For more information about Bristol Myers Squibb, visit us at BMS.com

https://news.bms.com/news/corporate-financial/2020/European-Medicines-Agency-Validates-Bristol-Myers-Squibbs-Type-II-Variation-Application-for-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-for-First-line-Treatment-of-Malignant-Pleural-Mesothelioma/default.aspx

View source version on businesswire.com: https://www.businesswire.com/news/home/20200915005684/en/

Pleural mesothelioma

European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma

09/15/2020CATEGORY:

Corporate/Financial News

Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs

Application based on positive results from pivotal Phase 3 CheckMate -743 trial

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

For patients with mNSCLC (PD-L1 ≥1%)

OPDIVO® + YERVOY® was assessed in a landmark phase 3 study that included patients regardless of histology

https://www.opdivoyervoymnsclc.com/

Baricitinib in Combination with Remdesivir

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor

Opdivo®(nivolumab) plus Yervoy®(ipilimumab)

Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial

Mon September 14, 2020 6:30 AM|PR Newswire|About: INCY, LLY

- Additional Analyses Ongoing to Understand Other Clinical Outcome Data

- Lilly's Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Baricitinib Continues

PR Newswire

INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and Incyte (INCY)

Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte and marketed as OLUMIANT®

https://www.olumiant.com/

Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial

September 14, 2020

https://investor.lilly.com/news-releases/news-release-details/baricitinib-combination-remdesivir-reduces-time-recovery

Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

To learn more about Lilly, please visit us at lilly.com

For additional information on Incyte, please visit Incyte.com

https://www.prnewswire.com/news-releases/baricitinib-in-combination-with-remdesivir-reduces-time-to-recovery-in-hospitalized-patients-with-covid-19-in-niaid-sponsored-actt-2-trial-301129865.html

https://seekingalpha.com/symbol/INCY

Lilly's baricitinib shows positive action in hospitalized COVID-19 patients

Sep. 14, 2020 7:17 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

Lilly's baricitinib shows positive action in hospitalized COVID-19 patients

Sep. 14, 2020 7:17 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3613560-lillys-baricitinib-shows-positive-action-in-hospitalized-covidminus-19-patients

NIAID-sponsored clinical trial, ACTT-2, evaluating the combination of baricitinib and Gilead Sciences' (NASDAQ:GILD) remdesivir in more than 1,000 hospitalized COVID-19 patients.

What is Olumiant? Olumiant is a once-daily pill to treat adults with moderately to severely active rheumatoid arthritis (RA) who have tried at least one other medicine called a tumor necrosis factor (TNF) antagonist, such as Humira® (adalimumab), Enbrel® (etanercept), and Remicade® (infliximab), that did not work well or could not be tolerated.

TYVYT® (sintilimab injection)

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor

Innovent and Lilly Jointly Announce Results of Six Clinical Studies of TYVYT® (sintilimab injection) to be Presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020

Mon September 14, 2020 6:00 AM|PR Newswire|About: IVBIY, LLY

SAN FRANCISCO and SUZHOU, China, Sept. 14, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: 01801)

Results of the ORIENT-12 Study: Sintilimab plus gemcitabine and platinum chemotherapy as first-line treatment for locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC).

For more information, please visit: www.innoventbio.com.

To learn more about Lilly, please visit us at www.lilly.com.

https://www.prnewswire.com/news-releases/innovent-and-lilly-jointly-announce-results-of-six-clinical-studies-of-tyvyt-sintilimab-injection-to-be-presented-at-the-european-society-for-medical-oncology-esmo-virtual-congress-2020-301129849.html

https://seekingalpha.com/symbol/IVBIY

Clinical Trials

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor

Vertex Announces European Medicines Agency Type II Variation Marketing Authorization Application Validation for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor in People with One Copy of the F508del Mutation

Mon September 14, 2020 4:15 AM|Business Wire|About: VRTX

LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX) (Nasdaq: VRTX)

For complete product information, please see the Summary of Product Characteristics that can be found on https://www.ema.europa.eu/en/medicines/human/EPAR/kaftrio.

https://www.vrtx.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005342/en/

https://www.vrtx.com/cystic-fibrosis/vertex-cystic-fibrosis-journey/

https://seekingalpha.com/symbol/VRTX

https://www.cysticfibrosis.org.uk/the-work-we-do/campaigning-hard/life-saving-drugs/triple-combination-therapy

https://seekingalpha.com/symbol/VRTX

Kaftrio (Trikafta in the US) – Triple combination therapy Read about Vertex Pharmaceuticals' triple combination therapy Kaftrio (known as Trikafta in the United States), which combines ivacaftor, tezacaftor and elexacaftor, and find out how it could help to treat people with cystic fibrosis (CF).

biotecMAX™ September/August/July 2020 insight

PFIZER AND BIONTECH PROPOSE EXPANSION OF PIVOTAL COVID-19 VACCINE TRIAL

Saturday, September 12, 2020 - 10:45am

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX)

Pfizer, BioNTech seek expansion of late-stage Covid vaccine trial

Sep. 13, 2020 7:50 AM ET|About: Pfizer Inc. (PFE)|By: Yoel Minkoff, SA News Editor

https://seekingalpha.com/news/3613497-pfizer-biontech-seek-expansion-of-late-stage-covid-vaccine-trial

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200912005013/en/

In addition, to learn more, please visit us on www.Pfizer.com

https://seekingalpha.com/symbol/BNTX

https://biontech.de/covid-19

Prognosis

Pfizer CEO Says Americans Could Get Covid Shot Before Year-End

By Riley Griffin and Anna EdneySeptember 13, 2020, 12:25 PM EDT

Bourla ‘comfortable’ that vaccine with BioNTech will be safe
Ex-FDA chief Gottlieb doubts any approval before election

https://www.bloomberg.com/news/articles/2020-09-13/pfizer-ceo-says-americans-could-get-covid-shot-before-year-end?srnd=premium

Aiming to address the global coronavirus pandemic: Project Lightspeed

AstraZeneca vaccine trials in U.K.

PFIZER AND BIONTECH PROPOSE EXPANSION OF PIVOTAL COVID-19 VACCINE TRIAL

COVID-19 vaccine AZD1222 clinical trials resumed in the UK

PUBLISHED12 September 2020

HEALTH AND SCIENCE

AstraZeneca coronavirus vaccine clinical trials resume in U.K. after pause over safety concerns

PUBLISHED SAT, SEP 12 20209:38 AM EDTUPDATED 2 HOURS AGOWill Feuer@WILLFOIA

https://www.cnbc.com/2020/09/12/astrazeneca-coronavirus-vaccine-clinical-trials-resume-in-uk-after-pause-over-safety-concerns.html

Prognosis Oxford to Resume Trial of AstraZeneca Vaccine By Stephanie Baker September 12, 2020, 9:23 AM EDT Updated on September 12, 2020, 11:32 AM EDT Study restarts after halt to assess participant’s illness No word from Astra or Oxford on status of separate U.S. trial

12 September 2020 14:20 BST

Oxford Covid-19 vaccine trial participant undeterred by pause

Man says he would continue with trial despite being worried about a second injection

https://www.theguardian.com/world/2020/sep/09/oxford-covid-19-vaccine-trial-participant-undeterred-by-pause

experimental Covid-19 vaccine candidates

PFIZER AND BIONTECH PROPOSE EXPANSION OF PIVOTAL COVID-19 VACCINE TRIAL

experimental Covid-19 vaccine candidates

Merck COVID-19 vaccine begins human testing in Belgium study - WSJ

Sep. 11, 2020 6:25 PM ET|About: Merck & Co., Inc. (MRK)|By: Carl Surran, SA News Editor

Merck Covid-19 Vaccine Begins Human Testing

The Phase 1 / 2 trial of Merck’s experimental coronavirus vaccine will evaluate whether it is safe to take and shows signs of generating an immune response

By Jared S. Hopkins

Updated Sept. 11, 2020 6:03 pm ET

https://www.wsj.com/articles/merck-covid-19-vaccine-begins-human-testing-11599859776

https://www.merck.com/