Moorestown, New Jersey, United States
biotecMAX™ October 2020 insight
FINTEPLA® (Fenfluramine)
Zogenix Receives Positive CHMP Opinion for FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Patients with Dravet Syndrome
Fri October 16, 2020 8:00 AM|GlobeNewswire|About: ZGNX
- Dravet syndrome is a rare, life-long, infant- and childhood-onset epilepsy associated with severe, treatment-resistant seizures
- CHMP positive opinion based on Phase 3 study data that demonstrated FINTEPLA® significantly reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, including stiripentol
- Final decision on Marketing Authorization Application expected by year-end 2020
EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (ZGNX)
FINTEPLA® (Fenfluramine)
https://seekingalpha.com/symbol/ZGNX
Zogenix Receives Positive CHMP Opinion for FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Patients with Dravet Syndrome
10.16.20PDF Version
- Dravet syndrome is a rare, life-long, infant- and childhood-onset epilepsy associated with severe, treatment-resistant seizures
- CHMP positive opinion based on Phase 3 study data that demonstrated FINTEPLA® significantly reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, including stiripentol
- Final decision on Marketing Authorization Application expected by year-end 2020
EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX),
oral insulin candidate, ORMD-0801
Oramed Issues Shareholder Update on Pivotal Phase 3 Oral Insulin Studies: Protocols Submitted to FDA
Fri October 16, 2020 8:40 AM|PR Newswire|About: ORMP
Efficacy data available after the 6-month dosing
PR Newswire
NEW YORK, Oct. 16, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (TASE: ORMP) (www.oramed.com)
oral insulin candidate, ORMD-0801
The Company has completed multiple Phase 2 clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901.
For more information, please visit www.oramed.com.
View original content:http://www.prnewswire.com/news-releases/oramed-issues-shareholder-update-on-pivotal-phase-3-oral-insulin-studies-protocols-submitted-to-fda-301153830.html
https://seekingalpha.com/symbol/ORMP
https://www.oramed.com/pipeline/
OPDIVO ® (nivolumab)
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Fri October 16, 2020 7:45 AM|Business Wire|About: BMY
Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ overall survival compared to chemotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)
OPDIVO ® (nivolumab)
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
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
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
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005370/en/
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
10/16/2020CATEGORY:
Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ overall survival compared to chemotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. The European Commission (EC), which is authorized to approve medicines for the European Union (EU), will now review the CHMP recommendation.
https://seekingalpha.com/symbol/BMY
Naxitamab and Omburtamab
Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma
Fri October 16, 2020 9:00 AM|GlobeNewswire|About: YMAB
NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (YMAB) (the “Company” or “Y-mAbs”) (Nasdaq: YMAB)
Naxitamab and Omburtamab
https://seekingalpha.com/symbol/YMAB
https://ymabs.com/research-development/pipeline/
NEW YORK , Oct. 16, 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 16, 2020
OXLUMO™ (lumasiran)
Alnylam Receives Positive CHMP Opinion for OXLUMO™ (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 in All Age Groups
Fri October 16, 2020 6:00 AM|Business Wire|About: ALNY
– Positive Opinion is Based on Results from ILLUMINATE-A and ILLUMINATE-B Phase 3 Studies –
– European Commission Decision on Approval Expected in Q4 2020 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY)
OXLUMO™ (lumasiran)
ILLUMINATE-A (NCT03681184) is a six-month randomized, double-blind, placebo-controlled, global, multicenter Phase 3 study (with a 54-month extension period) to evaluate the efficacy and safety of lumasiran in 39 patients, age six and older, with a documented diagnosis of PH1. Patients were randomized 2:1 to receive three monthly doses of lumasiran or placebo followed by quarterly maintenance doses at 3 mg/kg.
ILLUMINATE-B (NCT03905694) is a six-month, single arm, open-label, multicenter Phase 3 trial (with a 54-month extension period) that enrolled 18 patients with PH1 under the age of six. Lumasiran was administered according to a weight-based dosing regimen.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005076/en/
https://seekingalpha.com/symbol/ALNY
https://www.alnylam.com/alnylam-rnai-pipeline/
Alnylam Receives Positive CHMP Opinion for OXLUMO™ (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 in All Age Groups
Oct 16, 2020
– Positive Opinion is Based on Results from ILLUMINATE-A and ILLUMINATE-B Phase 3 Studies –
– European Commission Decision on Approval Expected in Q4 2020 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 16, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY),
https://investors.alnylam.com/press-release?id=25181
Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets),
ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV
Fri October 16, 2020 7:59 AM|Business Wire|About: GSK, PFE
- ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) reduces treatment dosing days from 365 to 12 or 6 per year
- Long-acting regimen is based on co-administration of cabotegravir and rilpivirine injections once-monthly or once every 2-months to treat HIV-1
- Vocabria (cabotegravir) tablets for use as an oral lead-in therapy with Edurant (rilpivirine tablets) prior to starting the long-acting regimen also receives positive CHMP opinion
LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. (PFE) and Shionogi Limited
Please refer to the full Summary of Product Characteristics for full prescribing information for EDURANT® (rilpivirine): https://www.medicines.org.uk/emc/product/4968/smpc
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005380/en/
cabotegravir and rilpivirine
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/PFE
Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets),
VASCEPA® (ICOSAPENT ETHYL)
Amarin gains after Vascepa found to significantly reduce ischemic events in PCI patients
Oct. 15, 2020 4:50 PM ET|About: Amarin Corporation plc (AMRN)|By: Brandy Betz, SA News Editor
https://amarincorp.com/default.aspx
INVESTOR RELATIONS / VASCEPA® (ICOSAPENT ETHYL) FOUND TO SIGNIFICANTLY REDUCE ISCHEMIC EVENTS IN PATIENTS WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN POST HOC SUBGROUP ANALYSES OF LANDMARK REDUCE-IT® STUDY PRESENTED AT TRANSCATHETER CARDIOVASCULAR THERAPEUTICS (TCT
BackPDF VersionOct 15, 2020
VASCEPA®, compared with placebo, significantly reduced primary composite first and total MACE (major adverse cardiovascular events) in post hoc exploratory analyses of patients with a history of PCI by 34% and 39%, respectively, and key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 34%
Administration of VASCEPA resulted in robust absolute risk reductions of 8.5% and 5.4% and numbers needed to treat (NNT) of 12 and 19, respectively, for both primary and key secondary (hard MACE) composite endpoints in post hoc exploratory subgroup analyses
Consistent and robust benefit seen in post hoc exploratory analyses of patients with a history of PCI across the hierarchy of endpoints prespecified for the full study cohort
DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN)
VASCEPA® (ICOSAPENT ETHYL)
https://www.vascepa.com/about-vascepa/
https://seekingalpha.com/symbol/AMRN
KTE-X19 is an autologous, anti-CD19 CAR T cell therapy
European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Fri October 16, 2020 7:28 AM|Business Wire|About: GILD
-- If Approved, KTE-X19 will be an Important New Advance for this Disease with a Poor Prognosis --
-- Kite would Become the First Company with Multiple Approved CAR T Therapies in Europe --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Medicines Agency (EMA)
KTE-X19 is an autologous, anti-CD19 CAR T cell therapy
For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences (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/20201016005357/en/
https://www.kitepharma.com/science-medicine/pipeline
October 16, 2020
EUROPEAN CHMP ADOPTS POSITIVE OPINION FOR KITE’S KTE-X19 FOR THE TREATMENT OF RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA
-- If Approved, KTE-X19 will be an Important New Advance for this Disease with a Poor Prognosis --
-- Kite would Become the First Company with Multiple Approved CAR T Therapies in Europe --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD),
biotecMAX™ October 2020 insight
KEYTRUDA® (pembrolizumab)
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Thu October 15, 2020 6:45 AM|Business Wire|About: MRK
KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Adult Patients With Relapsed or Refractory cHL After Frontline Therapy
KEYTRUDA Also Approved for Pediatric Patients With Refractory cHL, or cHL That Has Relapsed After Two or More Lines of Therapy
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK),
KEYTRUDA® (pembrolizumab)
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- 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)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
https://seekingalpha.com/symbol/MRK
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
October 15, 2020 6:45 am EDT
KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Adult Patients With Relapsed or Refractory cHL After Frontline Therapy
KEYTRUDA Also Approved for Pediatric Patients With Refractory cHL, or cHL That Has Relapsed After Two or More Lines of Therapy
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK)
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
More information is available by calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com.
For further information and to sign up, eligible patients may call 85-KEYTRUDA (855-398-7832) or visit www.keytruda.com.
For more information, visit www.merck.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005355/en/
Veklury (remdesivir)
Gilead Science lands WHO distinction for remdesivir
Oct. 15, 2020 1:06 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Clark Schultz, SA News Edito
Reference Number: CV002 (a)
Date of prequalification: 15 October 2020Basis of listing: Prequalified by WHOStatus: ActiveINN: RemdesivirTherapeutic area: COVID-19Dosage form & strength: Powder for solution for injection 100mgStorage condition: SRA accepted: No special precautions for storage; WHO recommended: Do not store above 30°C. The shelf-life at this storage condition is 36 monthsShelf life (months): 36Packaging: Vial, Type I clear glass 1x1
https://extranet.who.int/prequal/medicine/4444
https://seekingalpha.com/symbol/GILD
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
Zuranolone (SAGE-217)
Sage Therapeutics Announces Positive Interim, Topline Zuranolone Safety and Tolerability Data from Open-Label SHORELINE Study in Patients with MDD
Thu October 15, 2020 6:30 AM|Business Wire|About: SAGE
Zuranolone was generally well-tolerated at the 30 mg dose and by the initial patients treated with the 50 mg dose with an adverse event profile consistent with that seen in earlier trials
Nearly half of trial participants with positive response to initial 14-day course of zuranolone 30 mg did not need an additional zuranolone treatment course
For those who needed retreatment with the 30 mg dose, safety, tolerability and efficacy results were similar to those seen in the initial treatment course
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sage Therapeutics, Inc. (SAGE)
Phase 3 SHORELINE study, evaluating safety and tolerability of zuranolone 30 mg and 50 mg for major depressive disorder (MDD).
Zuranolone (SAGE-217)
https://www.sagerx.com/programs-research/pipeline/
For more information, please visit www.sagerx.com.
October 15, 2020
Sage Therapeutics Announces Positive Interim, Topline Zuranolone Safety and Tolerability Data from Open-Label SHORELINE Study in Patients with MDD
Zuranolone was generally well-tolerated at the 30 mg dose and by the initial patients treated with the 50 mg dose with an adverse event profile consistent with that seen in earlier trials
Nearly half of trial participants with positive response to initial 14-day course of zuranolone 30 mg did not need an additional zuranolone treatment course
For those who needed retreatment with the 30 mg dose, safety, tolerability and efficacy results were similar to those seen in the initial treatment course
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 15, 2020-- Sage Therapeutics, Inc. (NASDAQ: SAGE),
https://seekingalpha.com/symbol/SAGE
View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005330/en/
mRNA Vaccine Candidate BNT162b2 Against COVID-19
Pfizer and BioNTech may be first to show efficacy of COVID-19 vaccine
Oct. 15, 2020 8:16 AM ET|About: BioNTech SE (BNTX)|By: Yoel Minkoff, SA News Editor
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
List of authors.
- Edward E. Walsh, M.D.,
- Robert W. Frenck, Jr., M.D.,
- Ann R. Falsey, M.D.,
- Nicholas Kitchin, M.D.,
- Judith Absalon, M.D.,
- Alejandra Gurtman, M.D.,
- Stephen Lockhart, D.M.,
- Kathleen Neuzil, M.D.,
- Mark J. Mulligan, M.D.,
- Ruth Bailey, B.Sc.,
- Kena A. Swanson, Ph.D.,
- Ping Li, Ph.D.,
- et al.
https://www.nejm.org/doi/full/10.1056/NEJMoa2027906
The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)
COVID-19 vaccine
https://biontech.de/science/pipeline
https://seekingalpha.com/symbol/PFE
https://seekingalpha.com/symbol/BNTX
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
Regeneron's Inmazeb becomes first FDA-approved Ebola treatment
Oct. 14, 2020 4:53 PM ET|About: Regeneron Pharmaceuticals,... (REGN)|By: Jason Aycock, SA News Editor
FDA NEWS RELEASE
FDA Approves First Treatment for Ebola Virus
For Immediate Release:October 14, 2020
Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus
Inmazeb received an Orphan Drug designation for the treatment of Ebola virus infection. The Orphan Drug designation provides incentives to assist and encourage drug development for rare diseases. Additionally, the agency granted Inmazeb a Breakthrough Therapy designation for the treatment of Zaire ebolavirus infection.
https://seekingalpha.com/symbol/REGN
https://www.regeneron.com/pipeline
NURTEC™ ODT (rimegepant)
U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine
Wed October 14, 2020 7:30 AM|PR Newswire|About: BHVN
NURTEC ODT 75 mg has been shown in placebo-controlled trials to return patients to normal functioning within 60 minutes when used in the acute treatment of migraine and has also been shown to reduce monthly migraine days at the same 75 mg dose administered every other day for preventive treatment
NURTEC ODT is the first CGRP-targeting agent to file for regulatory approval as a single medication to treat both acute episodes and prevent future migraine attacks
PR Newswire
NEW HAVEN, Conn., Oct. 14, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN)
NURTEC™ ODT (rimegepant)
WHAT IS NURTEC ODT?
Nurtec ODT (rimegepant) orally disintegrating tablets is a prescription medicine for the acute treatment of migraine attacks with or without aura in adults. Nurtec ODT is not used as a preventive treatment of migraine. It is not known if Nurtec ODT is safe and effective in children.
See full Prescribing Information and Patient Information.
More information about Biohaven is available at www.biohavenpharma.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/us-fda-accepts-biohavens-supplemental-new-drug-application-snda-of-nurtec-odt-for-the-preventive-treatment-of-migraine-301151716.html
https://seekingalpha.com/symbol/BHVN
U.S. FDA ACCEPTS BIOHAVEN'S SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) OF NURTEC™ ODT FOR THE PREVENTIVE TREATMENT OF MIGRAINE
10/14/2020Acceptance marks critical milestone in Biohaven's efforts to develop NURTEC ODT as a unique dual therapy for both the preventive and acute treatment of migraineNURTEC ODT 75 mg has been shown in placebo-controlled trials to return patients to normal functioning within 60 minutes when used in the acute treatment of migraine and has also been shown to reduce monthly migraine days at the same 75 mg dose administered every other day for preventive treatment
https://www.biohavenpharma.com/investors/news-events/press-releases/10-14-2020
MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2
Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
Thu October 15, 2020 8:00 AM|GlobeNewswire|About: SNY
Sanofi (SNY) and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
- mRNA-based vaccine candidate MRT5500 induced potent neutralizing antibodies against SARS-CoV-2 in preclinical studies
- Two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients
- Phase 1/2 clinical trial anticipated to begin in the fourth quarter of 2020
PARIS and LEXINGTON, MASS. – October 15, 2020 - Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the preclinical results for MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19 disease.
MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/TBIO
October 15 2020
Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
https://www.sanofi.com/en/media-room/press-releases/2020/2020-10-15-14-00-00
COVID-19 (mRNA-1273)
Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
Tue October 13, 2020 11:04 AM|Business Wire|About: MRNA
Confirmation underscores Moderna’s commitment to make its vaccine available in Canada
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (MRNA), (Nasdaq: MRNA)
COVID-19 (mRNA-1273)
https://www.modernatx.com/cove-study
Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.
On September 22, the Canadian Government increased its confirmed order commitment to 20 million doses of mRNA-1273. Moderna (MODNA) remains on track to be able to deliver up to 56 million doses of its COVID-19 vaccine to help protect Canadians beginning in 2021. The Canadian vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services.
mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. As of Friday, October 9, the Phase 3 COVE study has enrolled approximately 28,618 participants with 22,194 having received their second vaccination. The clinicaltrials.gov identifier is NCT04470427. For more information about the Phase 3 COVE study, click here.
To learn more, visit www.modernatx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201013005849/en/
https://seekingalpha.com/symbol/MRNA
Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
October 13, 2020 at 11:04 AM EDTPDF Version
Confirmation underscores Moderna’s commitment to make its vaccine available in Canada
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 13, 2020-- Moderna, Inc., (Nasdaq: MRNA)
Pfizer, BioNTech inks COVID-19 vaccine pact with the New Zealand government
OCTOBER 11, 202011:28 PMUPDATED 15 HOURS AGO
New Zealand signs deal with Pfizer, BioNTech for COVID-19 vaccine
By Reuters Staff SYDNEY (Reuters)
Pfizer, BioNTech inks COVID-19 vaccine pact with the New Zealand government
Oct. 12, 2020 1:23 PM ET|About: Pfizer Inc. (PFE)|By: Vandana Singh, SA News Editor
https://seekingalpha.com/symbol/PFE
https://seekingalpha.com/symbol/BNTX
Dupixent® (dupilumab)
Dupixent® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial
Tue October 13, 2020 1:00 AM|GlobeNewswire|About: SNY
Dupixent® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial
- Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option
- Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo
- Significant and rapid improvement in lung function seen within two weeks and sustained for up to 52 weeks
- Results further support well-established safety profile of Dupixent
- U.S. and E.U. regulatory submissions for children aged 6-11 years planned by Q1 2021
PARIS and TARRYTOWN, N.Y. – October 13, 2020
Dupixent® (dupilumab)
please visit www.regeneron.com
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
https://www.regeneron.com/pipeline
October 13, 2020 at 12:59 AM EDT Back
DUPIXENT® (DUPILUMAB) SIGNIFICANTLY REDUCED SEVERE ASTHMA ATTACKS IN CHILDREN AND IS THE ONLY BIOLOGIC TO DEMONSTRATE IMPROVEMENT IN CHILDREN'S LUNG FUNCTION IN A RANDOMIZED PHASE 3 TRIAL
TARRYTOWN, N.Y. and PARIS, Oct. 13, 2020 /PRNewswire/ --
Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option
Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo
Significant and rapid improvement in lung function seen within two weeks and sustained for up to 52 weeks
U.S. and EU regulatory submissions for children aged 6-11 years planned by Q1 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
Fri October 16, 2020 8:00 AM|GlobeNewswire|About: SNY
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
- Recommendation based on pivotal trial that showed Dupixent plus topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearance, itch and health-related quality of life measures, compared to TCS alone
- Data further reinforce the well-established safety profile of Dupixent in adult and adolescent atopic dermatitis patients
- Dupixent would be the first biologic medicine available in the EU to treat this patient group and remains the only biologic medicine approved in moderate-to-severe atopic dermatitis for adolescents and adults
PARIS and TARRYTOWN, NY – October 16, 2020 – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab), recommending to extend the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy.
https://seekingalpha.com/symbol/BMY
AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test
Abbott Receives FDA Emergency Use Authorization for its COVID-19 IgM Antibody Blood Test
Mon October 12, 2020 9:00 AM|PR Newswire|About: ABT
- Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott's effort to offer tests across the disease progression of COVID-19
- Abbott's IgM test will give a more complete picture of where patients are in their recovery
PR Newswire
ABBOTT PARK, Ill., Oct. 12, 2020 /PRNewswire/ -- Abbott (ABT)
COVID-19 IgM Antibody Blood Test
Connect with us at www.abbott.com
View original content:http://www.prnewswire.com/news-releases/abbott-receives-fda-emergency-use-authorization-for-its-covid-19-igm-antibody-blood-test-301149788.html
https://seekingalpha.com/symbol/ABT
ABBOTT RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR ITS COVID-19 IGM ANTIBODY BLOOD TEST
- Data demonstrates highly reliable test results with 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset
- Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott's effort to offer tests across the disease progression of COVID-19
- Abbott's IgM test will give a more complete picture of where patients are in their recovery
Germany ramps up capacity of rapid COVID tests
Oct. 15, 2020 8:10 AM ET|About: Abbott Laboratories (ABT)|By: Clark Schultz, SA News Edito
https://seekingalpha.com/news/3622402-germany-ramps-up-capacity-of-rapid-covid-tests
filgotinib
Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis
Mon October 12, 2020 9:15 AM|Business Wire|About: GILD, GLPG
-- Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile --
-- Study Enrolled Biologic-Naïve and Biologic-Experienced Patients, a High Proportion of Whom Were Highly Refractory --
FOSTER CITY, Calif., & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & Nasdaq: GLPG)
filgotinib
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005470/en/
Full European Summary of Product Characteristics for filgotinib are available from the European Medicines Agency (EMA) website at www.ema.europa.eu
please visit the company’s website at www.gilead.com.
More information at www.glpg.com.
https://seekingalpha.com/symbol/GLPG
https://seekingalpha.com/symbol/GILD
https://www.glpg.com/clinical-pipelines
PHASE 2B/3 TRIAL SHOWS EFFICACY OF FILGOTINIB FOR THE INDUCTION AND MAINTENANCE OF REMISSION IN MODERATELY AND SEVERELY ACTIVE ULCERATIVE COLITIS
-- Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile --
-- Study Enrolled Biologic-Naïve and Biologic-Experienced Patients, a High Proportion of Whom Were Highly Refractory --
Foster City, Calif., & Mechelen, Belgium, October 12, 2020, 15.15 CET – Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG)
biotecMAX™ October 2020 insight
ProBeam particle accelerator
Varian Receives Investigational Device Exemption (IDE) and Prepares for First Ever Clinical Trial of FLASH Therapy
Mon October 12, 2020 8:15 AM|PR Newswire |About: VAR
- FLASH therapy delivers radiation at ultra-high dose rates and may be over 100 times faster compared to conventional radiation therapy
- The study will use Varian's ProBeam® proton particle accelerator modified with a specialized module with FLASH capabilities
- Trial to evaluate patients with bone metastases, typically deep-seated tumors
PR Newswire
PALO ALTO, Calif., Oct. 12, 2020 /PRNewswire/ -- Varian (NYSE: VAR)
For more information, visit http://www.varian.com
View original content:http://www.prnewswire.com/news-releases/varian-receives-investigational-device-exemption-ide-and-prepares-for-first-ever-clinical-trial-of-flash-therapy-301149339.html
The study, named FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), will involve the investigational use of Varian's ProBeam particle accelerator modified to offer this advanced non-invasive treatment option for patients with cancer.
ProBeam particle accelerator
https://www.varian.com/products/proton-therapy/treatment-delivery/probeam
ProBeam 360°
Next-generation proton therapy with a smaller footprint.
https://www.varian.com/products/proton-therapy/treatment-delivery/probeam-360
https://seekingalpha.com/symbol/VAR
VIR-3434 & VIR-7832
Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive Immunity to Viral Infection
Fri October 9, 2020 8:00 AM|GlobeNewswire|About: VIR
- Data demonstrate potential to enhance effector function of monoclonal antibodies and induce a protective T-cell or “vaccinal” response
- Therapeutic approach previously applied to treatment of oncologic diseases may now have broader implications across a range of infectious diseases
SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)
For more information, please visit www.vir.bio.
https://www.vir.bio/pipeline/#focus
Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive Immunity to Viral Infection
10/09/20 at 8:00 AM EDTPDF Version
- Data demonstrate potential to enhance effector function of monoclonal antibodies and induce a protective T-cell or “vaccinal” response
- Therapeutic approach previously applied to treatment of oncologic diseases may now have broader implications across a range of infectious diseases
SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR)
https://seekingalpha.com/symbol/VIR
SARS-CoV-2 Vaccine Candidate BNT162b2
Pfizer Canada and BioNTech Initiate Rolling Submission to Health Canada for SARS-CoV-2 Vaccine Candidate BNT162b2
Fri October 9, 2020 3:22 PM|Canada Newswire|About: BNTX
- Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ongoing Phase 3 study
KIRKLAND, QC and MAINZ, Germany, Oct. 9, 2020 /CNW/ - Pfizer Canada and BioNTech SE (BNTX) today announced the initiation of a rolling submission to Health Canada for BNT162b2, the lead candidate from the companies' vaccine development program against COVID-19.
Full information on previously released data can be found here. For further information about the ongoing Phase 3 trial, visit www.ClinicalTrials.gov using the identifier NCT04368728.
To learn more about Pfizer Canada, visit pfizer.ca
For more information, please visit www.BioNTech.de.
https://seekingalpha.com/symbol/BNTX
https://seekingalpha.com/symbol/PFE
COVID-19 vaccine
Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen's COVID-19 Vaccine Candidate
Thu October 8, 2020 7:50 AM|PR Newswire|About: JNJ
Agreement provides option for European Union Member States to secure up to 200 million additional doses for a total of up to 400 million doses
NEW BRUNSWICK, N.J., Oct. 8, 2020 /PRNewswire/ -- Johnson & Johnson (JNJ)
The Company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) that started in September.
For more information on Johnson & Johnson's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.
Learn more at www.jnj.com.
Learn more at www.janssen.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/johnson--johnson-announces-european-commission-approval-of-agreement-to-supply-200-million-doses-of-janssens-covid-19-vaccine-candidate-301148577.html
https://seekingalpha.com/symbol/JNJ
Janssen's investigational COVID-19 vaccine leverages Janssen's AdVac® technology.
THERMOCOOL SMARTTOUCH® SF Ablation Catheter
Biosense Webster Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation
Tue October 6, 2020 9:15 AM|PR Newswire|About: JNJPR Newswire
IRVINE, Calif., Oct. 6, 2020 /PRNewswire/ -- Johnson & Johnson Medical Devices Companies** t
Learn more at www.biosensewebster.com
For more information, visit www.jnjmedicaldevices.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/biosense-webster-receives-fda-approval-for-thermocool-smarttouch-sf-ablation-catheter-for-the-treatment-of-persistent-atrial-fibrillation-301146067.html
https://seekingalpha.com/symbol/JNJ
Biosense Webster, Inc.'s THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF).
https://www.biosensewebster.com/products/carto-3/smarttouch-catheter.aspx
https://www.biosensewebster.com/
J&J's Biosense Webster gets FDA nod for ablation catheter for atrial fibrillation
Oct. 6, 2020 10:15 AM ET|About: Johnson & Johnson (JNJ)|By: Meghavi Singh, SA News Editor
ALKS 3831 (olanzapine/samidorphan)
FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
Fri October 9, 2020 5:11 PM|PR Newswire|About: ALKS
DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)
For more information, please visit Alkermes' website at www.alkermes.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-support-of-alks-3831-for-the-treatment-of-schizophrenia-and-bipolar-i-disorder-301149686.html
https://seekingalpha.com/symbol/ALKS
Pipeline of Key Proprietary Products
We have a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer.
https://www.alkermes.com/research-and-development/pipeline
FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) t
AstraZeneca wins $486M from U.S. to develop, supply COVID antibody treatment
Oct. 9, 2020 9:32 PM ET|About: AstraZeneca PLC (AZN)|By: Carl Surran, SA News Editor
OCTOBER 9, 202011:34 PMUPDATED 2 DAYS AGO
U.S., AstraZeneca strike deal for COVID-19 antibody treatment touted by Trump
By Reuters Staff (Reuters)
https://seekingalpha.com/symbol/AZN
COVID-19 Information Hub
https://www.astrazeneca.com/media-centre/articles/2020/covid-19-information-hub.html
U.S., AstraZeneca strike deal for Covid-19 antibody treatment touted by Trump
PUBLISHED MON, OCT 12 20203:47 AM EDT
https://www.cnbc.com/2020/10/12/us-astrazeneca-strike-deal-for-covid-19-antibody-treatment.html
ENTYVIO® (vedolizumab)
Takeda's vedolizumab shows sustained effect in maintenance therapy for ulcerative colitis
Oct. 12, 2020 2:43 AM ET|About: Takeda Pharmaceutical Comp... (TAK)|By: Mamta Mayani, SA News Editor
VISIBLE open-label extension (OLE)
Vedolizumab Subcutaneous Long-Term Open-Label Extension Study
https://clinicaltrials.gov/ct2/show/NCT02620046
https://seekingalpha.com/symbol/TAK
Entyvio (vedolizumab)
Please see the full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Uses of ENTYVIO® (vedolizumab)
ENTYVIO is a prescription medicine used in adults for the treatment of:
- moderately to severely active ulcerative colitis
- moderately to severely active Crohn’s disease
STELARA® (ustekinumab)
STELARA® (ustekinumab) Five-Year Results Presented from Long-term Extension Study of Clinical Response and Remission in Patients with Moderate to Severe Crohn's Disease
Mon October 12, 2020 3:00 AM|PR NewswirePR Newswire
SPRING HOUSE, Pa., Oct. 12, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson
STELARA® (ustekinumab)
https://www.stelarahcp.com/
INDICATIONS
STELARA® (ustekinumab) is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).
STELARA® (ustekinumab) is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Please read the full Prescribing Information and Medication Guide for STELARA® 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/stelara-ustekinumab-five-year-results-presented-from-long-term-extension-study-of-clinical-response-and-remission-in-patients-with-moderate-to-severe-crohns-disease-301149840.html
https://seekingalpha.com/symbol/JNJ
PADCEV® (enfortumab vedotin-ejfv)
Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer
Mon October 12, 2020 6:45 AM|PR Newswire|About: ALPMY, SGENPR Newswire
TOKYO and BOTHELL, Wash., Oct. 12, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (SGEN)
PADCEV® (enfortumab vedotin-ejfv)
WHAT IS PADCEV™?
PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine. It is not known if PADCEV is safe and effective in children.
PADCEV was FDA-approved based on a clinical study that measured how many patients had a tumor response. There is another study with PADCEV to confirm the clinical benefit
For more information about the EV-201 clinical trial, please visit clinicaltrials.gov.
For more information, please visit our website at https://www.astellas.com/en.
For more information on our marketed products and robust pipeline, visit www.seagen.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/astellas-and-seagen-announce-positive-topline-results-from-second-cohort-of-patients-in-phase-2-pivotal-trial-of-padcev-enfortumab-vedotin-ejfv-in-advanced-urothelial-cancer-301149817.html
Seagen and Astellas Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer
10/12/2020
- Durable Responses Observed in Patients Who Had Previously Received Immunotherapy but Were Ineligible for Cisplatin in Locally Advanced or Metastatic Setting -
BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503,
https://seekingalpha.com/symbol/ALPMF
https://seekingalpha.com/symbol/SGEN
Mirikizumab
Mirikizumab Shows Continued Symptom Improvement and Reduction of Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial
Mon October 12, 2020 6:45 AM|PR Newswire|About: LLY
‒ These Phase 2 data reinforce the continued evaluation of mirikizumab in the ongoing, pivotal VIVID Phase 3 program as a potential treatment for patients with Crohn's disease
PR Newswire
INDIANAPOLIS, Oct. 12, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)
Mirikizumab
please visit us at www.lilly.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/mirikizumab-shows-continued-symptom-improvement-and-reduction-of-intestinal-inflammation-in-patients-with-crohns-disease-in-52-week-phase-2-trial-301149778.html
Phase 2 SERENITY study evaluating mirikizumab in moderately to severely active Crohn's disease.
October 12, 2020
https://seekingalpha.com/symbol/LLY
ULTOMIRIS® (ravulizumab-cwvz)
Alexion Receives FDA Approval for New Advanced Formulation of ULTOMIRIS® (ravulizumab-cwvz) with Significantly Reduced Infusion Time
Mon October 12, 2020 8:30 AM|Business Wire|About: ALXN
– New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients –
– ULTOMIRIS is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) –
BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN)
ULTOMIRIS® (ravulizumab-cwvz)
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.
Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.
https://seekingalpha.com/symbol/ALXN
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005090/en/
please visit www.alexion.com.
PIPELINE
Advancing Our Pipeline Every Day
https://alexion.com/our-research/pipeline