Seeking Biotech Alpha February/MARCH 2020 Insight

https://seekingalpha.com/symbol/CHGCY

cobas® SARS-CoV-2 Test

Seeking Biotech Alpha February/MARCH 2020 Insight

World Health Organization declares the coronavirus outbreak a global pandemic

PUBLISHED WED, MAR 11 202012:27 PM EDTUPDATED WED, MAR 11 20208:55 PM EDTDawn Kopecki@DAWN_KOPECKIBerkeley Lovelace Jr.@BERKELEYJRWilliam Feuer@WILLFOIANoah Higgins-Dunn@HIGGINSDUNN

VENCLYXTO® (venetoclax) in combination with obinutuzumab

World Health Organization declares the coronavirus outbreak a global pandemic

AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

Thu March 12, 2020 7:00 AM|PR Newswire|About: ABBV

- Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLYXTO had superior progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil[1],[5]

PR Newswire

NORTH CHICAGO, Ill., March 12, 2020 /PRNewswire/ -- AbbVie (ABBV)

https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html

https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia-301021997.html

https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia.htm

VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.

SKYRIZI® (risankizumab)

World Health Organization declares the coronavirus outbreak a global pandemic

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

AbbVie Announces New Formulary Listings for SKYRIZI® in the Treatment of Moderate to Severe Plaque Psoriasis

Wed March 11, 2020 1:07 PM|Canada Newswire|About: ABBV

SKYRIZI® is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe psoriasis.1
In clinical studies, SKYRIZI® significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).1
Non-Insured Health Benefits program lists SKYRIZI® on its formulary effective February 21, 2020.
Manitoba lists SKYRIZI® on its provincial formulary effective March 02, 2020.
SKYRIZI® is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the formularies of Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia and the Non-Insured Health Benefits program.

MONTRÉAL, March 11, 2020 /CNW/ - AbbVie (ABBV),

https://abbviecare.ca/

USE for SKYRIZI™ (risankizumab-rzaa) SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies

Thu March 12, 2020 6:45 AM|PR Newswire|About: MNK

STAINES-UPON-THAMES, United Kingdom, March 12, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

https://www.inomax.com/wp-content/themes/inomax-website/dist/downloads/Inomax-PI.pdf

http://www.mallinckrodt.com/

http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26576

https://www.prnewswire.com/news-releases/mallinckrodt-evaluates-the-potential-role-for-inhaled-nitric-oxide-to-treat-covid-19-associated-lung-complications-engages-with-scientific-governmental-and-regulatory-agencies-301022189.html

Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies Published: Mar 12, 2020 STAINES-UPON-THAMES, United Kingdom, March 12, 2020 /PRNewswire/ -- Mallinckrodt Pharmaceuticalsplc (NYSE: MNK)

leronlimab is a viral-entry inhibitor

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

leronlimab is a viral-entry inhibitor

CytoDyn’s First mTNBC Patient in Phase 1b/2 is in Remission and Oncologist Ordered Termination of Treatment with Carboplatin (chemotherapy drug) and Remains on Leronlimab Only as Monotherapy; Patient’s Testimony about Her Condition After Nearly 6 Months of Leronlimab Treatment is Very Strong

Thu March 12, 2020 9:18 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, March 12, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/pipeline/hiv

FDA Fast Track Designation for Leronlimab

Jardiance® (empagliflozin)

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

leronlimab is a viral-entry inhibitor

US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease

Thu March 12, 2020 8:00 AM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, March 12, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Jardiance® (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (LLY)

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

https://clinicaltrials.gov/ct2/show/NCT03594110

https://www.jardiance.com/

https://www.boehringer-ingelheim.us/

https://www.lillydiabetes.com/

https://www.prnewswire.com/news-releases/us-fda-grants-fast-track-designation-to-jardiance-for-the-treatment-of-chronic-kidney-disease-301022021.html

https://www.boehringer-ingelheim.us/press-release/us-fda-grants-fast-track-designation-jardiance-treatment-chronic-kidney-disease?itid=US%20FDA%20grants%20Fast%20Track%20designation%20to%20Jardiance%C2%AE%C2%A0for%20the%20treatment%20of%20chronic%20kidney%20disease

JARDIANCE is the first type 2 diabetes pill 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

Seeking Biotech Alpha February/MARCH 2020 Insight

Kaletra/Aluvia (lopinavir/ritonavir)

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Kaletra/Aluvia (lopinavir/ritonavir)

AbbVie Partnering with Global Authorities to Determine Efficacy of HIV Drug in Treating COVID-19

Mon March 9, 2020 8:45 AM|PR Newswire|About: ABBV

- AbbVie does not have access to Chinese clinical information and therefore cannot confirm its accuracy

- AbbVie donated Aluvia to the Chinese government for experimental use against COVID-19

- AbbVie is working with global health authorities to determine the efficacy and safety of lopinavir/ritonavir against COVID-19

- AbbVie does not anticipate disruption to the medicine supply for HIV patients as a result of the investigation of the effectiveness against COVID-19

PR Newswire

NORTH CHICAGO, Ill., March 9, 2020 /PRNewswire/ -- AbbVie (ABBV)

https://www.prnewswire.com/news-releases/abbvie-partnering-with-global-authorities-to-determine-efficacy-of-hiv-drug-in-treating-covid-19-301019533.html

https://news.abbvie.com/news/press-releases/abbvie-announces-extension-expiration-date-for-exchange-offers-for-allergan-notes-1-2-3-4.htm

What are KALETRA® (lopinavir/ritonavir) tablets and oral solution?2 KALETRA is a prescription medicine that is used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). It is not known if KAL

Descovy® for HIV PrEP

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Kaletra/Aluvia (lopinavir/ritonavir)

https://www.businesswire.com/news/home/20200310005729/en/

Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations

Tue March 10, 2020 11:32 AM|Business Wire|About: GILD

BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-presents-96-week-discover-trial-data-demonstrating-favorable-renal-and-bone-safety-profile-of-descovy-for-hiv-prep-in-at-risk-populations

https://www.descovy.com/prep

What is DESCOVY for PrEP? DESCOVY for PrEP (pre-exposure prophylaxis) is a once-daily prescription medicine for adults and adolescents at risk of HIV. It helps lower the chances of getting HIV through sex.

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer

Tue March 10, 2020 4:01 PM|PR NewswirePR Newswire

RARITAN, N.J., March 10, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

https://clinicaltrials.gov/ct2/show/NCT02609776

https://www.janssen.com/janssen-announces-us-fda-breakthrough-therapy-designation-granted-jnj-6372-treatment-non-small-cell

DuoBody® is a registered trademark of Genmab A/S.

https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics

https://www.prnewswire.com/news-releases/janssen-announces-us-fda-breakthrough-therapy-designation-granted-for--jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html

Mar 10, 2020 United States JNJ-6372, a dual-targeting EGFR-MET bispecific antibody, is being investigated for adults with non-small cell lung cancer (NSCLC) EGFR Exon 20 insertion mutations RARITAN, N.J., March 10, 2020 -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

Next-generation cytology test provides additional information for HPV-positive women who may have cervical pre-cancer
More sensitive than Pap cytology testing when used as triage test for HPV-positive screening results, helping to improve the detection of cervical pre-cancer
The first biomarker-based test specifically approved by the FDA to triage women with HPV-positive / Pap cytology-negative co-testing results, providing clinicians with a new option to guide patient management
Launch supports the goal of the World Health Organization to eliminate cervical cancer, which is nearly 100 percent preventable

Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://diagnostics.roche.com/#selectProfile

https://www.roche.com/

FDA OKs Roche cervical cancer test

Mar. 11, 2020 6:53 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3550440-fda-oks-roche-cervical-cancer-test

CINtec® PLUS Cytology

receptor 7 (TLR7) agonist vesatolimod

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study

Tue March 10, 2020 2:33 PM|Business Wire|About: GILD

-- Results Presented at CROI 2020 Support Further Evaluation of Vesatolimod as Part of Investigational Curative Regimens Aimed at Achieving ART-Free Control of HIV --

BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

https://www.businesswire.com/news/home/20200310005875/en/

https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/treatment-with-gileads-vesatolimod-is-evaluated-for-safety-and-virologic-and-immunologic-response-versus-placebo-in-phase-1b-hiv-functional-cure-stud

A Study of the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

https://clinicaltrials.gov/ct2/show/NCT02579382

Gilead's vesatolimod shows modest effect early-stage HIV study

Mar. 10, 2020 3:39 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3550263-gileads-vesatolimod-shows-modest-effect-early-stage-hiv-study

March 10, 2020 Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study -- Results Presented at CROI 2020 Support Further Evaluation of Vesatolimod as Part of Investigational Curative Regimens Aimed at Achieving ART-Free Control of HIV -- BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Wed March 11, 2020 6:59 AM|Business Wire|About: BMY

Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting

Approval based on CheckMate -040 trial in which Opdivo + Yervoy showed an overall response rate of 33% (16/49; 95% CI: 20-48) in this patient population1

Opdivo + Yervoy combination is now approved to treat four types of cancer

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

https://www.businesswire.com/news/home/20200311005141/en/

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting

Approval based on CheckMate -040 trial in which Opdivo + Yervoy showed an overall response rate of 33% (16/49; 95% CI: 20-48) in this patient population1

Opdivo + Yervoy combination is now approved to treat four types of cancer

CATEGORY:

CORPORATE/FINANCIAL NEWSWEDNESDAY, MARCH 11, 2020 6:59 AM EDT

https://www.opdivo.com/

https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-ye-0

Yervoy® (ipilimumab)

https://www.yervoy.com/

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab) This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

Seeking Biotech Alpha February/MARCH 2020 Insight

DURYSTA™ (bimatoprost implant)

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

DURYSTA™ (bimatoprost implant)

Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracameral Biodegradable Sustained-Release Implant to lower Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension Patients

Thu March 5, 2020 9:44 AM|PR Newswire|About: AGN

- Allergan continues five ongoing Phase 3 studies with DURYSTA™ to support further potential FDA label enhancement and rest of the world approvals -

PR Newswire

DUBLIN, March 5, 2020 /PRNewswire/ -- Allergan plc (AGN)

https://media.allergan.com/products/durysta_pi.pdf

https://www.durystahcp.com/

https://www.allergan.com/

https://www.prnewswire.com/news-releases/allergan-receives-fda-approval-for-durysta-bimatoprost-implant-the-first-and-only-intracameral-biodegradable-sustained-release-implant-to-lower-intraocular-pressure-in-open-angle-glaucoma-or-ocular-hypertension-patients-301017349.html

https://seekingalpha.com/symbol/AGN

FDA OKs Allergan eye implant for glaucoma

Mar. 5, 2020 10:00 AM ET|About: Allergan plc (AGN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3549041-fda-oks-allergan-eye-implant-for-glaucoma

Durysta (bimatoprost implant) 10 mcg

Idylla™ MSI

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

DURYSTA™ (bimatoprost implant)

Biocartis Announces New Immuno-Oncology Project with Bristol-Myers Squibb Aimed at Registration of Idylla™ MSI test in China

March 05, 2020 01:01 ET | Source: Biocartis NVmultilang-release

PRESS RELEASE
5 March 2020, 07:01 CET

Biocartis Announces New Immuno-Oncology Project with Bristol-Myers Squibb Aimed at Registration of Idylla™ MSI test in China

Mechelen, Belgium, 5 March 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’

https://www.biocartis.com/en-US/meet-idylla/idylla-assays/idylla-msi-assay

https://www.biocartis.com/en-US

https://investors.biocartis.com/sites/default/files/press-releases/2020/200304_pr_bms_china_eng_final.pdf

https://smallcapsdaily.com/nanoviricides-to-produce-broad-spectrum-antiviral-clinical-trial-candidates-for-covid-19/

IdyllaTM MSI Assay

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

NanoViricides, Inc. Reports Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

Thu March 5, 2020 4:11 PM|Newsfile|About: NNVCNewsfile Corp

The Company has been working on a drug candidate to address the COVID-19 and has made significant progress in this regard

New York, New York--(Newsfile Corp. - March 5, 2020) - NanoViricides, Inc. (NNVC)

NanoViricides, Inc. Reports Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

The Company has been working on a drug candidate to address the COVID-19 and has made significant progress in this regard

https://www.newsfilecorp.com/release/53198

http://www.nanoviricides.com/index.html

https://seekingalpha.com/symbol/NNVC

NanoViricides, Inc. - Pipeline

MAVIRET® (glecaprevir/pibrentasvir)

Isturisa (osilodrostat) oral tablets

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

Fri March 6, 2020 7:00 AM|PR Newswire|About: ABBV

- Today's EC decision makes MAVIRET the only pan-genotypic (genotypes 1-6) 8-week treatment option for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis

PR Newswire

NORTH CHICAGO, Ill., March 6, 2020 /PRNewswire/ -- AbbVie (ABBV)

https://www.prnewswire.com/news-releases/european-commission-grants-abbvie-marketing-authorization-shortening-maviret-glecaprevirpibrentasvir-treatment-duration-to-eight-weeks-for-treatment-naive-chronic-hcv-patients-with-genotype-3-and-compensated-cirrhosis-301018922.html

https://www.mavyret.com/

March 6, 2020

European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

https://news.abbvie.com/news/press-releases/european-commission-grants-abbvie-marketing-authorization-shortening-maviret-glecaprevirpibrentasvir-treatment-duration-to-eight-weeks-for-treatment-nave-chronic-hcv-patients-with-genotype-3-and-compensated-cirrhosis.htm

https://seekingalpha.com/pr/17802094-enanta-s-hcv-collaboration-partner-abbvie-receives-marketing-authorization-from-european

Enanta’s HCV Collaboration Partner AbbVie Receives Marketing Authorization from European Commission to Shorten MAVIRET® (glecaprevir/pibrentasvir) Duration to Eight Weeks for Treatment-Naïve Genotype 3 HCV Patients with Compensated Cirrhosis

Fri March 6, 2020 7:05 AM|Business Wire|About: ENTA

MAVIRET now available in the EU as an 8-week treatment option for treatment-naïve, chronic hepatitis C virus (HCV) patients without cirrhosis or with compensated cirrhosis, regardless of genotype*
European Commission’s decision makes MAVIRET the only 8-week treatment regimen indicated for all common HCV genotypes (GT1—6) in treatment-naïve, chronic HCV patients both without cirrhosis or with compensated cirrhosis, without the need for HCV genotype testing
Glecaprevir, one of the two direct-acting antivirals (DAAs) in MAVIRET, was discovered by Enanta and developed and commercialized by AbbVie

WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (ENTA),

https://seekingalpha.com/symbol/ENTA

MAVYRET is a prescription medicine used to treat adults and children 12 years of age and older or weighing at least 99 pounds (45 kilograms) with chronic (lasting a long time) hepatitis C virus (hep C): Genotypes (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Or GT 1 infection and have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Isturisa (osilodrostat) oral tablets

FDA Approves New Treatment for Adults with Cushing's Disease

NEWS PROVIDED BY

U.S. Food and Drug Administration

Mar 06, 2020, 18:41 ET

SHARE THIS ARTICLE

SILVER SPRING, Md., March 6, 2020 /PRNewswire/

FDA Approves Osilodrostat, A Non-Surgical Option for Cushing's Disease

MARCH 07, 2020Patrick Campbell

https://www.mdmag.com/medical-news/isturisa-fda-approves-osilodrostat-nonsurgical-option-cushings-disease-novartis

https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products

Osilodrostat. Osilodrostat, sold under the brand name Isturisa, a medication for the treatment for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. It is taken by mouth

https://seekingalpha.com/news/3549544-fda-oks-novartis-osilodrostat-for-adrenal-gland-disorder

Designating an Orphan Product: Drugs and Biological Products

leronlimab (PRO 140)

Isturisa (osilodrostat) oral tablets

CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140)

Sun March 8, 2020 5:52 PM|GlobeNewswire|About: CYDY

Coronavirus Can Quickly Progress to Severe Pneumonia and Even Death Due to Immune Hyperactivity Including Acute Respiratory Distress Syndrome (ARDS); CytoDyn's Trial Focuses on Patients Who Develop Mild-To-Moderate Respiratory Illness After Contracting Coronavirus

CytoDyn Negotiating to Expedite Setup of Treatment Clinics in New York and San Francisco

VANCOUVER, Washington, March 08, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/newsroom/press-releases/detail/392/cytodyn-files-ind-and-protocol-for-phase-2-clinical-trial .

CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Coronavirus Patients with Leronlimab (PRO 140)

https://www.cdc.gov/coronavirus/2019-ncov/index.html

https://www.kgw.com/article/news/health/coronavirus/coronavirus-drug-leronlimab-cytodyn-inflammatory/283-84bd963b-3451-443e-a17d-623c7318ce2a

Vancouver-based company awaits approval to go to clinical trials with coronavirus drug

The president and CEO of CytoDyn Inc. believes leronlimab will help people with moderate to severe cases of coronavirus.Author: Mike BennerPublished: 10:21 PM PDT March 9, 2020Updated: 11:06 PM PDT March 9, 2020

PORTLAND, Ore. —

FDA Fast Track Designation for Leronlimab

Seeking Biotech Alpha February/MARCH 2020 Insight

leronlimab (PRO 140)

Acthar® Gel (Repository Corticotropin Injection)

leronlimab (PRO 140)

CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol

Wed March 4, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, March 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/pipeline/cancer

https://www.cytodyn.com/newsroom/press-releases/detail/390/cytodyn-treats-first-patient-with-leronlimab-in-phase-2

https://www.nytimes.com/reuters/2020/03/04/world/europe/04reuters-roche-device.html

Leronlimab and Cancer

Elecsys® GALAD score

Acthar® Gel (Repository Corticotropin Injection)

leronlimab (PRO 140)

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions
When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1
Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is minimally invasive to patients

Basel, 4 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://www.roche.com/

Roche Gets U.S. Breakthrough Tag for Liver Cancer Diagnosis Approach By Reuters March 4, 2020, 2:05 a.m. ET

Acthar® Gel (Repository Corticotropin Injection)

Mallinckrodt Announces Publication of New Data on Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Dermatomyositis/Polymyositis Published in Open Access Rheumatology: Research and Reviews

Wed March 4, 2020 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, March 4, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

https://www.mallinckrodt.com/investors/presentation-documents/

https://www.acthar.com/pdf/Acthar-PI.pdf

http://www.mallinckrodt.com/

https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26546

https://www.acthar.com/patient

https://www.prnewswire.com/news-releases/mallinckrodt-announces-publication-of-new-data-on-acthar-gel-repository-corticotropin-injection-in-rheumatoid-arthritis-systemic-lupus-erythematosus-and-dermatomyositispolymyositis-published-in-open-access-rheumatology-resea-301016020.html

What is Acthar Gel? Acthar® Gel (repository corticotropin injection) is used for: The reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus) Treatment of infantile spasms in infants and children under 2 years of age Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina Treatment for people with symptoms of sarcoidosis Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus) Treatment for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM) Adjunctive therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis

Trofinetide is an investigational drug

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Acthar® Gel (Repository Corticotropin Injection)

ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation for Trofinetide for the Treatment of Rett Syndrome

Tue March 3, 2020 5:50 PM|Business Wire|About: ACAD

Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.

https://www.acadia-pharm.com/

https://www.businesswire.com/news/home/20200303006075/en/

https://seekingalpha.com/symbol/ACAD

http://www.neurenpharma.com/irm/content/default.aspx

https://seekingalpha.com/symbol/NURPF

Acadia's trofinetide nabs RPD tag in U.S. for rare neurological disorder

Mar. 4, 2020 7:13 AM ET|About: ACADIA Pharmaceuticals... (ACAD)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3548471-acadias-trofinetide-nabs-rpd-tag-in-u-s-for-rare-neurological-disorder

Trofinetide (also known as NNZ-2566) in Fragile X Syndrome

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Allergan and Editas Medicine Announce Dosing of First Patient in Landmark Phase 1/2 Clinical Trial of CRISPR Medicine AGN-151587 (EDIT-101) for the Treatment of LCA10

Wed March 4, 2020 5:00 AM|GlobeNewswire|About: AGN, EDIT

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Additional patient enrollment to the BRILLIANCE Clinical Trial is ongoing

DUBLIN, Ireland and CAMBRIDGE, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- Allergan plc (AGN), a leading global pharmaceutical company, and Editas Medicine, Inc. (EDIT)

Allergan and Editas Medicine dose first patient mid-stage study of blindness medicine

Mar. 4, 2020 7:40 AM ET|About: Allergan plc (AGN)|By: Mamta Mayani, SA News Editor

Allergan (NYSE:AGN) and Editas Medicine (NASDAQ:EDIT

https://seekingalpha.com/news/3548489-allergan-and-editas-medicine-dose-first-patient-mid-stage-study-of-blindness-medicine

www.clinicaltrials.gov (NCT#03872479)

https://www.allergan.com/

https://www.editasmedicine.com/

https://www.editasmedicine.com/gene-editing-pipeline/

https://seekingalpha.com/symbol/EDIT

https://seekingalpha.com/symbol/AGN

https://clinicaltrials.gov/ct2/show/NCT03872479?term=agn-151587&draw=2&rank=1

Single Ascending Dose Study in Participants With LCA10 = Sponsor: Allergan Collaborator: Editas Medicine, Inc. Information provided by (Responsible Party): Allergan

Omnipod® DASH Insulin Management System (Omnipod DASH™ System)

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Insulet’s Omnipod DASH™ System Voted 2020 Product of the Year in Health Systems Category by 40,000 U.S. Consumers

Thu March 5, 2020 6:00 AM|Business Wire|About: PODD

Product Innovation Award Further Validates Omnipod as a Consumer Preferred Solution

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (PODD)

https://productoftheyearusa.com/

https://www.womansday.com/life/a30517486/product-of-the-year-2020-winners/

http://www.insulet.com/

https://www.myomnipod.com/home

https://www.businesswire.com/news/home/20200305005044/en/

https://seekingalpha.com/symbol/PODD

Insulet (PODD) Presents At Raymond James Institutional Investors Conference - Slideshow

Mar. 4, 2020 3:19 PM ET | About: Insulet Corporation (PODD)

https://seekingalpha.com/article/4329595-insulet-podd-presents-raymond-james-institutional-investors-conference-slideshow

CONSIDERING THE OMNIPOD DASH™ SYSTEM? Whether you are new to Pod Therapy or a current Podder™ interested in finding out if you have coverage for the Omnipod DASH™ System - We are here to help! Click on the link below to take the next step towards getting started on the Omnipod DASH™ System.

Seeking Biotech Alpha February/MARCH 2020 Insight

EPIDIOLEX® (cannabidiol) oral solution, CV

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

JAMA Neurology Publishes Results from Positive Phase 3 Trial of EPIDIOLEX® (cannabidiol) oral solution in Children with Seizures Associated with Dravet Syndrome

Mon March 2, 2020 11:13 AM|GlobeNewswire|About: GWPH

GlobeNewswire

CARLSBAD, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (NASDAQ: GWPH, GW, the Company or the Group)

https://www.epidiolex.com/

https://www.gwpharm.com/

http://ir.gwpharm.com/news-releases/news-release-details/jama-neurology-publishes-results-positive-phase-3-trial

https://seekingalpha.com/symbol/GWPH

What is EPIDIOLEX? EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

European Medicines Agency Grants PRIME and Advanced Therapy Medicinal Product Designations to Janssen's RPGR Gene Therapy for X-Linked Retinitis Pigmentosa

Mon March 2, 2020 8:30 AM|PR Newswire

Designations will accelerate the regulatory review timeline of this potential gene therapy for European patients living with X-linked retinitis pigmentosa

PR Newswire

RARITAN, N.J., March 2, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) Retinitis Pigmentosa GTPase Regulator (RPGR)

https://clinicaltrials.gov/ct2/show/NCT03252847?term=rpgr&draw=2&rank=1

https://www.prnewswire.com/news-releases/european-medicines-agency-grants-prime-and-advanced-therapy-medicinal-product-designations-to-janssens-rpgr-gene-therapy-for-x-linked-retinitis-pigmentosa-301014359.html

https://clinicaltrials.gov/ct2/show/NCT03252847?term=rpgr&draw=2&rank=1

https://ghr.nlm.nih.gov/condition/retinitis-pigmentosa

J&J gene therapy nabs accelerated review status in Europe for vision loss disorder

Mar. 2, 2020 11:32 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

European Medicines Agency Grants PRIME and Advanced Therapy Medicinal Product Designations to Janssen's RPGR Gene Therapy for X-Linked Retinitis Pigmentosa Mar 02, 2020 United States Only RPGR gene therapy program to receive PRIME designation Designations will accelerate the regulatory review timeline of this potential gene therapy for European patients living with X-linked retinitis pigmentosa RARITAN, N.J., March 2, 2020 -- The Janssen Pharmaceutical Companies of Johnson & Johnson

Remdesivir (GS-5734, Nuc inhibitor)

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

China slaps down local biotech over claims it could produce Gilead’s experimental coronavirus drug

Published: Mar 2, 2020 10:27 a.m. ET

Chinese Biotech Censured for False Claim on Gilead’s Virus Drug

Bloomberg NewsBloombergMarch 1, 2020

https://finance.yahoo.com/news/chinese-biotech-censured-false-claim-040207427.html

Severe 2019-nCoV Remdesivir RCT

https://clinicaltrials.gov/ct2/show/NCT04257656?term=remdesivir&draw=2&rank=1

First Case of 2019 Novel Coronavirus in the United States

January 31, 2020
DOI: 10.1056/NEJMoa2001191
Chinese Translation 中文翻译

https://www.nejm.org/doi/10.1056/NEJMoa2001191

February 26, 2020

Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

-- U.S. FDA Grants Investigational New Drug Authorization to Study Remdesivir for the Treatment of COVID-19 --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 26, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19

First Case of 2019 Novel Coronavirus in the United States January 31, 2020 DOI: 10.1056/NEJMoa2001191 Chinese Translation 中文翻译

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma

March 02, 2020

https://seekingalpha.com/symbol/SNY

FDA OKs Sanofi drug for previously treated multiple myeloma

Mar. 2, 2020 12:51 PM ET|About: Sanofi (SNY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3547590-fda-oks-sanofi-drug-for-previously-treated-multiple-myeloma

What is POMALYST® (pomalidomide)?

POMALYST® (pomalidomide) is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment. It is not known if POMALYST is safe and effective in children.

https://pomalyst.com/

https://seekingalpha.com/pr/17796656-sanofi-fda-approves-sarclisa-isatuximab-irfc-for-patients-relapsed-refractory-multiple

Sanofi : FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

Mon March 2, 2020 1:51 PM|GlobeNewswire|About: SNY

FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial
FDA approval based on data from the only randomized Phase 3 trial (ICARIA-MM) to evaluate an anti-CD38 in combination with pom-dex that has presented results to date
Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approximately 32,000 Americans are diagnosed with multiple myeloma each year

PARIS – March 2, 2020 – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

March 02 2020 Sanofi : FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

Mayzent™ (siponimod)

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Esbriet® (pirfenidone)

Novartis receives Health Canada approval for Mayzent™ (siponimod) to treat secondary progressive multiple sclerosis with active disease

Tue March 3, 2020 6:00 AM|Canada Newswire

MayzentTM (siponimod) is the first oral treatment approved for people living with secondary progressive multiple sclerosis (SPMS) with active disease, and the first treatment approved for SPMS with active disease in almost 15 years1
Most people living with relapsing remitting MS (RRMS) will develop SPMS2
Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of people living with SPMS, showing MayzentTM significantly reduced the risk of disease progression, including impact on physical disability3

DORVAL, QC, March 3, 2020 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis)

https://www.mayzent.com/isi

https://www.mayzent.com/index.jsp?utm_medium=paid&utm_term=mayzent%2520siponimod&utm_content=paidsearch&utm_source=google&utm_campaign=Mayzent.com_HCPBrand_Google_10.2019

https://www.novartis.ca/en

https://seekingalpha.com/symbol/NVS

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

Esbriet® (pirfenidone)

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Esbriet® (pirfenidone)

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease

Tue March 3, 2020 1:00 AM|Business Wire|About: RHHBY

– There are currently no FDA-approved treatments for unclassifiable ILD (uILD), a debilitating, severe respiratory condition –

– The designation is based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks –

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

https://www.esbriet.com/

https://www.gene.com/

https://www.businesswire.com/news/home/20200302006109/en/

https://www.gene.com/media/press-releases/14840/2020-03-02/fda-grants-breakthrough-therapy-designat

Monday, Mar 2, 2020

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease

There are currently no FDA-approved treatments for unclassifiable ILD (uILD), a debilitating, severe respiratory condition
The designation is based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks

South San Francisco, CA -- March 2, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

Seeking Biotech Alpha February/MARCH 2020 Insight

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Immunoglobulin A Nephropathy (IgAN) Published in Kidney International Reports

Thu March 5, 2020 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, March 5, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK),

Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)

Mon March 2, 2020 6:45 AM|PR Newswire|About: MNK

PR Newswire

STAINES-UPON-THAMES, United Kingdom, March 2, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

https://www.prnewswire.com/news-releases/mallinckrodt-initiates-rolling-submission-of-new-drug-application-to-the-us-food-and-drug-administration-fda-for-terlipressin-for-the-treatment-of-patients-with-hepatorenal-syndrome-type-1-hrs-1-301014108.html

https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT

https://www.prnewswire.com/news-releases/data-on-acthar-gel-repository-corticotropin-injection-therapy-in-immunoglobulin-a-nephropathy-igan-published-in-kidney-international-reports-301016912.html

Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1) - Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if approved - STAINES-UPON-THAMES, United Kingdom, March 2, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK)

Rubraca® (rucaparib) Tablets

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

Clovis Oncology Announces Availability and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Spain

Mon March 2, 2020 4:00 AM|Business Wire|About: CLVS

https://www.clovisoncology.com/

https://www.businesswire.com/news/home/20200302005009/en/

https://clovisoncology.com/pipeline/rucaparib/

https://seekingalpha.com/symbol/CLVS

Rubraca is a prescription medicine used for: The maintenance treatment of adults with ovarian cancer, fallopian tube, primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival Compared with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

Mon March 2, 2020 6:30 AM|Business Wire|About: MRK

Data from Pivotal Phase 3 KEYNOTE-204 Study to be Presented at an Upcoming Medical Meeting and Submitted to Regulatory Authorities

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

Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)

https://clinicaltrials.gov/ct2/show/NCT02684292

https://www.businesswire.com/news/home/20200302005320/en/

https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-significantly-improved-progression-free-survival

Merck's Keytruda tops Seattle Genetics' Adcetris in late-stage lymphoma study

Mar. 2, 2020 8:23 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3547387-mercks-keytruda-tops-seattle-genetics-adcetris-in-late-stage-lymphoma-study

How KEYTRUDA works KEYTRUDA is not chemotherapy or radiation therapy—it is an immunotherapy and it works with your immune system to help fight cancer. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

tanezumab 2.5 mg

Gilead to Acquire Forty Seven for $4.9 Billion

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis

Mon March 2, 2020 6:45 AM|PR Newswire|About: LLY, PFE

NEW YORK and INDIANAPOLIS, March 2, 2020 /PRNewswire/ -- Pfizer Inc. (PFE) and Eli Lilly and Company (LLY)

Tanezumab is an investigational monoclonal antibody that works by selectively targeting, binding to and inhibiting NGF. NGF levels increase in the body as a result of injury, inflammation or in chronic pain states.

https://www.pfizer.com/

https://www.lilly.com/

https://www.prnewswire.com/news-releases/us-fda-accepts-regulatory-submission-for-tanezumab-a-potential-first-in-class-treatment-for-patients-with-chronic-pain-due-to-moderate-to-severe-osteoarthritis-301013995.html

https://seekingalpha.com/symbol/PFE

U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis 03/02/2020 NEW YORK and INDIANAPOLIS, March 2, 2020 /PRNewswire/ -- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)

ALUNBRIG® (brigatinib)

Gilead to Acquire Forty Seven for $4.9 Billion

Takeda Receives Positive CHMP Opinion for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Non-Small Cell Lung Cancer

Mon March 2, 2020 8:00 AM|Business Wire|About: TAK

– If Approved by the European Medicines Agency, ALUNBRIG Would Become an Important First-Line Treatment Option for ALK+ NSCLC Patients –

– Positive Opinion is Based on Data from Phase 3 ALTA-1L Trial, in which ALUNBRIG Demonstrated Superiority in both Overall and Intracranial Efficacy Compared to Crizotinib –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.alunbrig.com/

https://www.takeda.com/

https://www.businesswire.com/news/home/20200302005068/en/

https://seekingalpha.com/symbol/TAK

What Is ALUNBRIG®? ALUNBRIG is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC): that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body, and who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib It is not known if ALUNBRIG is safe and effective in children. There is an ongoing study to learn how ALUNBRIG works over a longer period of time

Gilead to Acquire Forty Seven for $4.9 Billion

March 02, 2020

Gilead to Acquire Forty Seven for $4.9 Billion

– Gilead Gains Forty Seven’s Investigational Immuno-Oncology Therapy in Multiple Clinical Studies for Diseases Including Myelodysplastic Syndrome, Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma –

– Transaction Supports Gilead’s Strategic Focus in Oncology and Gives Access to Potential New First-in-Class Program and Innovative Pipeline –

FOSTER CITY, Calif. & MENLO PARK, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV)

https://www.fortyseveninc.com/

https://www.fortyseveninc.com/science

https://seekingalpha.com/symbol/FTSV

Gilead takes out Forty Seven for $4.9B

Mar. 2, 2020 7:38 AM ET|About: Forty Seven, Inc. (FTSV)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3547352-gilead-takes-out-forty-seven-for-4_9b

Gilead to Acquire Forty Seven for $4.9 Billion – Gilead Gains Forty Seven’s Investigational Immuno-Oncology Therapy in Multiple Clinical Studies for Diseases Including Myelodysplastic Syndrome, Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma – – Transaction Supports Gilead’s Strategic Focus in Oncology and Gives Access to Potential New First-in-Class Program and Innovative Pipeline –

Seeking Biotech Alpha February 2020 Insight

BGB-3245, an investigational, next-generation B-RAF inhibitor

MapKure, BeiGene and SpringWorks Announce Initiation of Phase 1 Clinical Trial of BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors

Thu February 27, 2020 7:14 AM|GlobeNewswire|About: BGNE, SWTX

-- Phase 1 Study Initiated in Australia with IND Cleared to Expand Study to the U.S.--

-- Industry-Leading Scientific Advisory Board Formed to Support Advancement of BGB-3245 --

CAMBRIDGE, Mass. and BEIJING and STAMFORD, Conn., Feb. 27, 2020 (GLOBE NEWSWIRE) -- MapKure, LLC, a clinical-stage company developing precision medicines for patients with life-threatening diseases, together with BeiGene, Ltd. (BGNE) and SpringWorks Therapeutics, Inc. (SWTX), who are joint owners of MapKure

Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors

https://clinicaltrials.gov/ct2/show/NCT04249843?term=BGB-3245&draw=2&rank=1#wrapper

https://www.beigene.com/

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

https://www.springworkstx.com/

https://www.springworkstx.com/pipeline/

https://seekingalpha.com/symbol/BGNE

https://seekingalpha.com/symbol/SWTX

http://ir.beigene.com/static-files/ac21f420-ebe7-4627-a9c2-c38bd7940b8d

MapKure, BeiGene and SpringWorks Announce Initiation of Phase 1 Clinical Trial of BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors February 27, 2020 at 7:14 AM EST PDF Version -- Phase 1 Study Initiated in Australia with IND Cleared to Expand Study to the U.S.-- -- Industry-Leading Scientific Advisory Board Formed to Support Advancement of BGB-3245 -- CAMBRIDGE, Mass. and BEIJING and STAMFORD, Conn., Feb. 27, 2020 (GLOBE NEWSWIRE) -- MapKure, LLC, a clinical-stage company developing precision medicines for patients with life-threatening diseases, together with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) and SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), who are joint owners of MapKure

Acthar® Gel (Repository Corticotropin Injection)

BGB-3245, an investigational, next-generation B-RAF inhibitor

Mallinckrodt to Present New Data from two Studies on Acthar® Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at Fifth Annual ACTRIMS Forum 2020

Thu February 27, 2020 6:45 AM|PR Newswire|About: MNK

PR Newswire

STAINES-UPON-THAMES, United Kingdom, Feb. 27, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

https://www.acthar.com/pdf/Acthar-PI.pdf

http://www.mallinckrodt.com/

http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26516

https://www.prnewswire.com/news-releases/mallinckrodt-to-present-new-data-from-two-studies-on-acthar-gel-repository-corticotropin-injection-therapy-in-multiple-sclerosis-ms-relapse-at-fifth-annual-actrims-forum-2020-301012267.html

resiniferatoxin (RTX)

BGB-3245, an investigational, next-generation B-RAF inhibitor

Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

Sorrento Therapeutics Presents Interim Positive Results of Phase 1b Resiniferatoxin (RTX) in Cancer Pain Trial

Thu February 27, 2020 3:30 PM|GlobeNewswire|About: SRNE

Fourteen subjects with advanced cancer pain received epidural RTX (04 to 15 ug)
Most common treatment-related adverse event was transient post-procedure related pain
Three subjects at the higher doses had rapid and marked pain reduction after treatment
One additional cohort was added to further evaluate a 25 ug dose for upcoming Phase 3 studies

SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE)

https://sorrentotherapeutics.com/pipeline/

More information on this trial can be found at www.clinicaltrials.gov (NCT03226574).

Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

https://clinicaltrials.gov/ct2/show/NCT03226574?term=NCT03226574&draw=2&rank=1

https://sorrentotherapeutics.com/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/

https://seekingalpha.com/symbol/SRNE

Sorrento Therapeutics Presents Interim Positive Results of Phase 1b Resiniferatoxin (RTX) in Cancer Pain Trial Feb 27, 2020 at 3:30 PM EST PDF Version Fourteen subjects with advanced cancer pain received epidural RTX (04 to 15 ug) Most common treatment-related adverse event was transient post-procedure related pain Three subjects at the higher doses had rapid and marked pain reduction after treatment One additional cohort was added to further evaluate a 25 ug dose for upcoming Phase 3 studies SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento")

Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

Pfizer gets OK for Advil Dual Action

Feb. 28, 2020 4:43 PM ET|About: Pfizer Inc. (PFE)|By: Jason Aycock, SA News Editor

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211733Orig1s000ltr.pdf

Advil Dual Action with Acetaminophen (ibuprofen 125 mg/acetaminophen 250 mg) tablet.

VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

AbbVie Provides Update from Phase 3 Study Evaluating VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine in Newly-Diagnosed Patients with Acute Myeloid Leukemia (AML)

Fri February 28, 2020 6:53 PM|PR Newswire|About: ABBV

- At the time of the primary analysis median OS was 7.2 months in the venetoclax arm and 4.1 months in the comparator arm

- Results are indicative of clinical activity of venetoclax in combination with low-dose cytarabine

- AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options¹ ²

- Results will be published in a peer-reviewed journal and presented at an upcoming medical meeting

- Phase 3 VIALE-A trial evaluating venetoclax in combination with azacytidine is ongoing; at this time, indications for venetoclax remain unchanged

PR Newswire

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

https://news.abbvie.com/news/press-releases/abbvie-receives-us-fda-accelerated-approval-for-venclexta-venetoclax-for-treatment-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm

https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html

https://www.prnewswire.com/news-releases/abbvie-provides-update-from-phase-3-study-evaluating-venclexta-venetoclax-in-combination-with-low-dose-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-aml-301013711.html

https://seekingalpha.com/news/3547230-abbvie-venetoclax-combo-trial-misses-endpoint

AbbVie venetoclax combo trial misses endpoint

Feb. 28, 2020 7:10 PM ET|About: AbbVie Inc. (ABBV)|By: Jason Aycock, SA News Editor

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

Merck Announces New Data from Broad HIV Program at CROI 2020

Mon March 2, 2020 6:45 AM|Business Wire|About: MRK

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

https://www.croiconference.org/

https://www.businesswire.com/news/home/20200302005284/en/

Merck Announces New Data from Broad HIV Program at CROI 2020 Monday, March 2, 2020 6:45 am EST

Seeking Biotech Alpha February 2020 Insight

CABOMETYX® (cabozantinib)

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer

Tue February 25, 2020 4:06 PM|Business Wire|About: EXEL

– Analysis for the co-primary endpoint of objective response rate and an interim analysis of progression-free survival expected in the second half of 2020 –

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

https://www.businesswire.com/news/home/20200225005987/en/

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy

https://clinicaltrials.gov/ct2/show/NCT03690388

https://cabometyx.com/downloads/CABOMETYXUSPI.pdf

https://www.exelixis.com/

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-first-100-patients-enrolled-phase-3-cosmic

https://www.businesswire.com/news/home/20200225005987/en/

https://seekingalpha.com/symbol/EXEL

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.

Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

SELLAS Announces Positive Follow-Up Phase 1/2 Clinical Data for Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

Wed February 26, 2020 8:30 AM|GlobeNewswire|About: SLS

- Final analysis shows statistically significant median overall survival of 21 months in patients who received GPS compared to previously reported 5.4 months in the control arm (p-value < 0.02) -

- Data provides additional support for ongoing pivotal Phase 3 REGAL study of GPS in patients with AML -

NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS)

GPS Compared With BAT in AML CR2/CR2p

https://www.clinicaltrials.gov/ct2/show/NCT04229979?term=galinpepimut-S&draw=2&rank=3

https://www.sellaslifesciences.com/Home/default.aspx

https://seekingalpha.com/symbol/SLS

SELLAS PIPELINE EXPANDED DEVELOPMENT PIPELINE

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir, which has been undergoing clinical tests to determine if it can effectively treat the coronavirus, He Zhimin, deputy director of the National Intellectual Property Administration said (link in Chinese) at a press conference on Tuesday.

The U.S. drugmaker has applied for eight patents for the drug and the other five are still being reviewed, according to He. The eight patents cover areas including compounds, manufacturing methods and drug usage.

Antiviral drug Remdesivir gains 3 patents in China

http://www.china.org.cn/china/2020-02/26/content_75745874.htm

Antiviral drug Remdesivir gains three patents in China: official

Source: Xinhua| 2020-02-25 19:05:41|Editor: huaxia

BEIJING, Feb. 25 (Xinhua)

http://www.xinhuanet.com/english/2020-02/25/c_138817801.htm

Xinhua, February 26, 2020 -Antiviral drug Remdesivir gains 3 patents in China

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

Wed February 26, 2020 5:30 PM|GlobeNewswire|About: ESPR

- NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins -
- First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved -
- Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, 2020 -
- Further Underscores Esperion’s Commitment to Patient Affordability -
- Conference Call and Webcast on Thursday, February 27 at 8:00 a.m. Eastern Time -

ANN ARBOR, Mich., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR)

Feb 26, 2020

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

https://pi.esperion.com/nexlizet/nexlizet-pi.pdf

https://www.esperion.com/

NEXLETOL™ (bempedoic acid) Tablet

https://seekingalpha.com/symbol/ESPR

https://www.esperion.com/investors-media/press-releases/?request=aHR0cHM6Ly9lc3Blcmlvbi5nY3Mtd2ViLmNvbS8vbmV3cy1yZWxlYXNlcy9uZXdzLXJlbGVhc2UtZGV0YWlscy9lc3Blcmlvbi1hbm5vdW5jZXMtZmRhLWFwcHJvdmFsLW5leGxpemV0dG0tYmVtcGVkb2ljLWFjaWQtYW5k

Feb 26, 2020 Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine - NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins - - First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved - - Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, 2020 - - Further Underscores Esperion’s Commitment to Patient Affordability - - Conference Call and Webcast on Thursday, February 27 at 8:00 a.m. Eastern Time - ANN ARBOR, Mich., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR)

CYRAMZA® (ramucirumab)

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Remdesivir for the Treatment of COVID-19

FDA Advisory Committee Votes in Favor of Lilly's CYRAMZA® (ramucirumab) as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

02/26/2020Download PDFRegulatory submission based on the positive Phase 3 RELAY study of CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations

INDIANAPOLIS, Feb. 26, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

https://www.cyramza.com/

VOLUME 20, ISSUE 12, P1655-1669, DECEMBER 01, 2019

Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30634-5/fulltext

http://uspl.lilly.com/cyramza/cyramza.html

https://www.lilly.com/

https://www.lillyoncology.com/

https://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-lillys-cyramza-ramucirumab-as-first-line-treatment-for-metastatic-egfr-mutated-non-small-cell-lung-cancer-301012180.html

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

https://clinicaltrials.gov/ct2/show/NCT02411448

Important Facts About CYRAMZA® (sigh-RAM-zuh). It is also known as ramucirumab. CYRAMZA is a prescription medicine used to treat certain types of cancer. It is given by intravenous (IV) infusion. An IV infusion is when a needle is placed into your vein and a medicine is given slowly. CYRAMZA is prescribed in these ways: By itself or with a chemotherapy medicine called paclitaxel to treat certain kinds of stomach cancer or cancer of the area where the stomach and esophagus (food pipe) meet that is advanced or has spread to other parts of the body. The area where the stomach and esophagus meet is often called the gastroesophageal (GE) junction. CYRAMZA is for people whose stomach cancer got worse during or after certain other types of chemotherapy. With a chemotherapy medicine called docetaxel to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has gotten worse during or after another type of chemotherapy. People who have tumors with certain abnormal genes should not receive CYRAMZA unless they have already been treated with medicine that targets those changes and their cancer became worse during treatment. With a combination of chemotherapy medicines called FOLFIRI (irinotecan, folinic acid, and fluorouracil). This is given to treat colorectal cancer (CRC) that has spread to other parts of the body and has gotten worse during or after certain other types of chemotherapy. By itself to treat a type of liver cancer called hepatocellular carcinoma (HCC). CYRAMZA is for people who have levels of alpha-fetoprotein of at least 400 nanograms per milliliter (ng/mL) in their blood and have been treated with another type of chemotherapy medicine called sorafenib.

Remdesivir for the Treatment of COVID-19

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Remdesivir for the Treatment of COVID-19

Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

Wed February 26, 2020 5:00 PM|Business Wire|About: GILD

-- U.S. FDA Grants Investigational New Drug Authorization to Study Remdesivir for the Treatment of COVID-19 --

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

https://www.gilead.com/purpose/advancing-global-health/covid-19

https://www.businesswire.com/news/home/20200226005955/en/

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS.

Gilead Sciences Update On The Company’s Ongoing Response To COVID-19

Seeking Biotech Alpha February 2020 Insight

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer

Fri February 21, 2020 6:59 AM|Business Wire|About: BMY

First approval of Opdivo for treatment of advanced esophageal cancer

First Immuno-Oncology treatment option approved for patients with esophageal cancer in Japan

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

https://www.businesswire.com/news/home/20200221005172/en/

https://news.bms.com/press-release/corporatefinancial-news/japan-ministry-health-labor-and-welfare-approves-opdivo-nivo-0

https://www.opdivo.com/

https://www.bms.com/

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer BACK ADVANCED LUNG CANCER OPDIVO for people who have had prior treatments for non-small cell lung cancer OPDIVO for people who have had prior treatments for small cell lung cancer Advanced Lung Cancer Advanced Kidney Cancer Advanced Liver Cancer Colorectal Cancer (MSI-H/dMMR) Melanoma Head and Neck Squamous Cell Cancer Advanced Bladder Cancer Classical Hodgkin Lymphoma

Trulicity® (dulaglutide)

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

Trulicity® (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease

Fri February 21, 2020 7:50 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Feb. 21, 2020 /PRNewswire/

https://www.trulicity.com/

http://pi.lilly.com/us/trulicity-uspi.pdf

https://www.lillydiabetes.com/

https://www.lilly.com/

https://investor.lilly.com/news-releases/news-release-details/trulicityr-dulaglutide-first-and-only-type-2-diabetes-medicine

https://www.prnewswire.com/news-releases/trulicity-dulaglutide-is-the-first-and-only-type-2-diabetes-medicine-approved-to-reduce-cardiovascular-events-in-adults-with-and-without-established-cardiovascular-disease-301009459.html

Important Facts About Trulicity® (Trῡ-li-si-tee). It is also known as dulaglutide. Trulicity is a prescription medicine to improve blood sugar in adults with type 2 diabetes. You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm. Use Trulicity together with the diet and exercise that your doctor recommends. Trulicity is not insulin. It should not be the first medicine you take for diabetes.

Nexletol (bempedoic acid)

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

YESCARTA® (Axicabtagene Ciloleucel)

Esperion Wins FDA Approval for First Heart Medicine, Nexletol

Feb. 21, 2020, 2:30 PM

FDA OKs Esperion's cholesterol med Nexletol

Feb. 21, 2020 3:08 PM ET|About: Esperion Therapeutics,... (ESPR)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3544573-fda-oks-esperions-cholesterol-med-nexletol

https://seekingalpha.com/symbol/ESPR

https://pi.esperion.com/nexletol/nexletol-pi.pdf

https://www.esperion.com/science/bempedoic-acid/

Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

Fri February 21, 2020 4:38 PM|GlobeNewswire|About: ESPR

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. in Nearly 20 Years for Indicated Patients –
– NEXLETOL Lowers LDL-Cholesterol with a First-in-Class Mechanism –
– Fills an Unmet Need for Affordable Medicines for Millions of Patients with ASCVD or HeFH –
– NEXLETOL will be Commercially Available in the U.S. March 30, 2020 –
– Conference Call and Webcast on Monday, February 24 at 8:00 a.m. Eastern Time –

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)

https://seekingalpha.com/pr/17787122-esperion-announces-fda-approval-of-nexletol-bempedoic-acid-tablet-oral-daily-non-statin-ldl

NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. (1)

YESCARTA® (Axicabtagene Ciloleucel)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

YESCARTA® (Axicabtagene Ciloleucel)

Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA

(24 February, 2020, Shanghai) Today, Fosun Kite Biotechnology(“Fosun Kite”) based in Shanghai, a company invested by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK),

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* Announcement in Relation to Acceptance of New Drug Application Filing from Fosun Kite Biotechnology Co., Ltd.*

https://www1.hkexnews.hk/listedco/listconews/sehk/2020/0224/2020022400822.pdf

Gilead JV application for CAR-T cancer therapy accepted in China

Feb. 24, 2020 7:46 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Liz Kiesche, SA News Editor

https://seekingalpha.com/news/3544746-gilead-jv-application-for-car-t-cancer-therapy-accepted-in-china

https://www.yescarta.com/

YESCARTA is the first CAR T therapy for adults living with certain types of non-Hodgkin lymphoma who have failed at least 2 other kinds of treatment. YESCARTA is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

ALUNBRIG® (brigatinib)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

Mon February 24, 2020 8:00 AM|Business Wire|About: TAK

– ALUNBRIG has Potential to Expand its Indication in ALK+ Metastatic Non-Small Cell Lung Cancer –

– Prescription Drug User Fee Act (PDUFA) Target Action Date Set for June 23, 2020 –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.alunbrig.com/

https://www.takeda.com/

https://www.takeda.com/newsroom/newsreleases/2019/takeda-announces-u.s.-fda-acceptance-of-supplemental-new-drug-application-for-alunbrig-brigatinib-as-a-first-line-treatment-for-alk-metastatic-non-small-cell-lung-cancer/

https://www.businesswire.com/news/home/20200224005128/en/

https://seekingalpha.com/symbol/TAK

INDICATION ALUNBRIG is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that have a certain abnormal anaplastic lymphoma kinase (ALK) gene that has spread to other parts of their body, and who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib. It is not known if ALUNBRIG is safe and effective in children. There is an ongoing study to learn how ALUNBRIG works over a longer period of time.

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Mon February 24, 2020 7:00 AM|GlobeNewswire|About: AVXL

Published in Journal of Neuroimmunology, Results Highlight ANAVEX®2-73 (blarcamesine) Shown to Protect and Repair Myelin Forming Cells

ANAVEX®2-73 (blarcamesine) Provides optimal Protection of Oligodendroglia against Glutamate Toxicity

NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (AVXL) (“Anavex” or the “Company”) (Nasdaq: AVXL)

https://www.sciencedirect.com/science/article/abs/pii/S0165572819305831

https://www.anavex.com/

https://seekingalpha.com/symbol/AVXL

https://www.anavex.com/anavex-life-sciences-announces-publication-of-foundational-data-for-anavex2-73-blarcamesine-in-multiple-sclerosis-ms/

Seeking Biotech Alpha February 2020 Insight

KEYTRUDA® (pembrolizumab) Injection, 100 mg

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

Merck Receives Complete Response Letter from the US FDA for Supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule

Tue February 18, 2020 7:17 PM|Business Wire|About: MRK

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

https://www.merck.com/clinical-trials/index.html

https://www.businesswire.com/news/home/20200218006165/en/

https://www.mrknewsroom.com/news-release/corporate-news/merck-receives-complete-response-letter-us-fda-supplemental-biologics-li

https://www.keytruda.com/

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

ruxolitinib cream 0.75% or 1.5%

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

Wed February 19, 2020 7:30 AM|Business Wire|About: INCY

For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

About Ruxolitinib Cream

Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild-to-moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

https://www.incyte.com/

https://www.businesswire.com/news/home/20200219005204/en/

https://seekingalpha.com/symbol/INCY

Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis 19 February, 2020 PDF Version Primary and secondary endpoints met in both TRuE-AD1 and TRuE-AD2 WILMINGTON, Del.--(BUSINESS WIRE)--Feb. 19, 2020-- Incyte (Nasdaq:INCY)

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

Wed February 19, 2020 8:12 AM|Business Wire|About: ALPMY, SGEN

- Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Astellas Pharma Inc. (ALPMF) (TSE: 4503

https://www.seattlegenetics.com/

https://www.astellas.com/en/

https://www.businesswire.com/news/home/20200219005512/en/

https://seekingalpha.com/symbol/ALPMY

https://seekingalpha.com/symbol/SGEN

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.

FreeStyle Libre system

AXS-07 is a novel, oral, investigational medicine

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

New Real-World Data Show that Abbott's FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes

Thu February 20, 2020 8:00 AM|PR Newswire|About: ABT

- People in Germany living with Type 1 or Type 2 diabetes on insulin showed a sustained reduction in HbA1c over one year following use of the FreeStyle Libre technology

PR Newswire

MADRID, Feb. 20, 2020 /PRNewswire/ -- Abbott (ABT)

https://www.abbott.com/

https://www.prnewswire.com/news-releases/new-real-world-data-show-that-abbotts-freestyle-libre-system-delivers-positive-health-outcomes-for-people-with-type-1-and-type-2-diabetes-301007694.html

https://seekingalpha.com/symbol/ABT

FreeStyle Libre Indications and Important Safety Information

AXS-07 is a novel, oral, investigational medicine

Axsome Therapeutics Completes Patient Enrollment in the INTERCEPT Phase 3 Trial of AXS-07 in the Early Treatment of Migraine

Thu February 20, 2020 7:00 AM|GlobeNewswire|About: AXSM

NEW YORK, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM)

https://axsome.com/

https://axsome.com/axs-pipeline/about-axs-07/

https://seekingalpha.com/symbol/AXSM

AXS-07 is a novel, oral, investigational medicine under development for the acute treatment of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life.

valoctocogene roxaparvovec

AXS-07 is a novel, oral, investigational medicine

BioMarin's Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020

Thu February 20, 2020 4:05 PM|PR Newswire|About: BMRN

If approved, 1st Gene Therapy in U.S. for the Treatment of Any Type of Hemophilia

FDA Also Accepts Premarket Approval (PMA) Application for Companion Diagnostic Test, a 1st for a Gene Therapy

PR Newswire

SAN RAFAEL, Calif., Feb. 20, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.biomarin.com/products/pipeline/bmn-270/

https://investors.biomarin.com/2020-02-20-BioMarins-Biologics-License-Application-for-Valoctocogene-Roxaparvovec-Accepted-for-Priority-Review-by-FDA-with-Review-Action-Date-of-August-21-2020

https://www.prnewswire.com/news-releases/biomarins-biologics-license-application-for-valoctocogene-roxaparvovec-accepted-for-priority-review-by-fda-with-review-action-date-of-august-21-2020-301008771.html

https://seekingalpha.com/symbol/BMRN

Valoctocogene Roxaparvovec (BMN 270) for Hemophilia A

Seeking Biotech Alpha February 2020 Insight

Beovu® (brolucizumab) injection

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Novartis receives EC Approval for Beovu®, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020

Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase1
For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments2-4
Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)1,5
Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)1,5

Basel, February 17, 2020

https://www.beovu.com/?utm_medium=paid&utm_term=Branded_Exact%20|%20beovu&utm_source=google&utm_campaign=Branded_Exact

https://seekingalpha.com/symbol/NVS

BEOVU® (brolucizumab-dbll) injection is used for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States

Mon February 17, 2020 10:00 AM|PR Newswire|About: GSKPR Newswire

WARREN, N.J., Feb. 17, 2020 /PRNewswire/ -- GlaxoSmithKline (GLAXF) (LSE/NYSE: GSK)

https://www.voltarengel.com/

https://www.gsk.com/

https://seekingalpha.com/symbol/GSK

Voltaren Arthritis Pain Gel is the first prescription strength nonsteroidal anti-inflammatory gel for arthritis pain relief, available over-the-counter in Spring 2020.

VYNDAQEL® (tafamidis)

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Tue February 18, 2020 6:45 AM|Business Wire|About: PFE

—VYNDAQEL is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalizations in adults with wild-type or hereditary ATTR-CM—

—VYNDAQEL is the first approved medicine in the EU to treat both ATTR-CM and stage 1 symptomatic transthyretin amyloid polyneuropathy (ATTR-PN)—

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

http://labeling.pfizer.com/ShowLabeling.aspx?id=11685

https://www.pfizer.com/

https://www.pfizer.com/news/press-release/press-release-detail/european_commission_approves_vyndaqel_the_first_treatment_in_the_eu_for_transthyretin_amyloid_cardiomyopathy_attr_cm

https://www.businesswire.com/news/home/20200218005225/en/

https://seekingalpha.com/symbol/PFE

VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

Abbott Introduces Next-Generation Heart Rhythm Management Devices in Europe, Featuring State-of-the-Art Patient App and Bluetooth Connectivity

Tue February 18, 2020 7:45 AM|PR Newswire|About: ABT

- Gallant ICD and CRT-D devices feature a more comfortable design, preferred by patients without compromising on battery longevity or high-voltage output, which remain among the highest in the industry

PR Newswire

ABBOTT PARK, Ill., Feb. 18, 2020 /PRNewswire/ -- Abbott (ABT)

https://www.abbott.com/

https://www.prnewswire.com/news-releases/abbott-introduces-next-generation-heart-rhythm-management-devices-in-europe-featuring-state-of-the-art-patient-app-and-bluetooth-connectivity-301006253.html

https://seekingalpha.com/symbol/ABT

https://www.abbott.com/consumer/cardiovascular.html

A healthy heart is essential to good health. That's why at Abbott, we throw our hearts into advancing treatments for people with cardiovascular disease. Our breakthrough medical technologies — many of which are minimally invasive — help restore people's health so they can get back to living their best lives, faster.

PROCYSBI® (Cysteamine Bitartrate)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

PROCYSBI® (Cysteamine Bitartrate)

Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules

Tue February 18, 2020 8:00 AM|Business Wire|About: HZNP

-- Oral granules in packets provide an additional, tear-open option for people living with cystinosis --

DUBLIN--(BUSINESS WIRE)-- Horizon Therapeutics plc (Nasdaq: HZNP)

https://www.businesswire.com/news/home/20200218005293/en/

https://www.hzndocs.com/PROCYSBI-Prescribing-Information.pdf

https://www.horizontherapeutics.com/

https://seekingalpha.com/symbol/HZNP

Our Pipeline

We are relentless in pursuing breakthroughs that boldly change the lives of the communities we serve.

https://www.horizontherapeutics.com/our-pipeline/

What is PROCYSBI? PROCYSBI (cysteamine bitartrate) delayed-release capsules is a prescription medicine used to treat a medical condition called nephropathic cystinosis in adults and children 1 year of age and older. It is not known if PROCYSBI is safe and effective in children under 1 year of age.

Tecentriq® (atezolizumab)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

PROCYSBI® (Cysteamine Bitartrate)

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

Wed February 19, 2020 1:00 AM|Business Wire|About: RHHBY

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

https://www.businesswire.com/news/home/20200218006211/en/

https://www.gene.com/

https://www.gene.com/topics/cancer-immunotherapy

https://www.tecentriq.com/

TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. A type of lung cancer called non-small cell lung cancer (NSCLC). A type of breast cancer called triple-negative breast cancer (TNBC). A type of lung cancer called small cell lung cancer (SCLC).

Seeking Biotech Alpha February 2020 Insight

Tecentriq in combination with chemotherapy

China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://www.tecentriq.com/

Roche's Tecentriq OK'd in China for first-line lung cancer

Feb. 14, 2020 7:00 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3542132-roches-tecentriq-okd-in-china-for-first-line-lung-cancer

https://www.gene.com/medical-professionals/pipeline

TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma, A type of lung cancer called non-small cell lung cancer (NSCLC)., A type of breast cancer called triple-negative breast cancer (TNBC)., A type of lung cancer called small cell lung cancer (SCLC).

STELARA® (ustekinumab)

Tecentriq in combination with chemotherapy

New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Fri February 14, 2020 2:00 AM|PR Newswire

First Study to Evaluate Intestinal Ultrasound Monitoring in an Interventional Setting

PR Newswire

VIENNA, Feb. 14, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf

https://clinicaltrials.gov/ct2/show/NCT03107793

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab (STARDUST)

https://www.prnewswire.com/news-releases/new-phase-3b-interim-data-from-stardust-study-show-two-thirds-of-patients-with-moderately-to-severely-active-crohns-disease-achieved-clinical-remission-after-two-doses-of-stelara-ustekinumab-301005006.html

Overview of Crohn's Disease

ESPAÑOL

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract. Understanding Crohn’s disease can help you and your loved ones navigate the uncertainty that comes with a new diagnosis.

https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview

New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Feb 14, 2020Austria

https://www.janssen.com/new-phase-3b-interim-data-stardust-study-show-two-thirds-patients-moderately-severely-active-crohns

WHAT IS STELARA®? STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease. STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active ulcerative colitis. STELARA® is a prescription medicine used to treat adults and children 12 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). STELARA® is a prescription medicine used to treat adults 18 years and older with active psoriatic arthritis. STELARA® can be used alone or with the medicine methotrexate.

nelipepimut-S (NPS)

Tecentriq in combination with chemotherapy

ERVEBO® (Ebola Zaire Vaccine, Live)

SELLAS Life Sciences Provides Regulatory Update for Nelipepimut-S (NPS) for Triple Negative Breast Cancer (TNBC) Following FDA Feedback

Fri February 14, 2020 8:30 AM|GlobeNewswire|About: SLSGlobeNewswire

NEW YORK, Feb. 14, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS)

https://www.sellaslifesciences.com/Home/default.aspx

https://seekingalpha.com/symbol/SLS

EXPANDED DEVELOPMENT PIPELINE PROGRAM

ERVEBO® (Ebola Zaire Vaccine, Live)

ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

Fri February 14, 2020 11:20 AM|Business Wire|About: MRK

Democratic Republic of the Congo One of the First African Countries to Register ERVEBO

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

https://www.businesswire.com/news/home/20200214005376/en/

https://www.fda.gov/vaccines-blood-biologics/ervebo

ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification Democratic Republic of the Congo One of the First African Countries to Register ERVEBO Friday, February 14, 2020 11:20 am EST KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK)

Opdivo (nivolumab)

ERVEBO® (Ebola Zaire Vaccine, Live)

Remdesivir (GS-5734, Nuc inhibitor)

Updated CheckMate -025 Results Show 26% of Patients Treated with Opdivo are Alive at Five Years in Patients with Previously Treated Advanced or Metastatic Renal Cell Carcinoma

Sat February 15, 2020 2:30 PM|Business Wire|About: BMY

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

https://www.businesswire.com/news/home/20200215005014/en/

https://www.bms.com/

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that 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.

https://www.opdivo.com/

Remdesivir (GS-5734, Nuc inhibitor)

ERVEBO® (Ebola Zaire Vaccine, Live)

Remdesivir (GS-5734, Nuc inhibitor)

Feb 16, 2020 11:16 AM

Second Batch of Experimental Gilead Coronavirus Drug Arrives in Wuhan

By Jia Tianqiong, Di Ning, Lu Yutong and Flynn Murphy

The remdesivir trials are backed by Capital Medical University in collaboration with the Chinese Academy of Medical Sciences.

Seeking Biotech Alpha February 2020 Insight

OTEZLA® (apremilast)

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Amgen Canada Receives Approval of Marketing Authorization Transfer of OTEZLA® for the Treatment of Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Wed February 12, 2020 7:00 AM|Canada Newswire|About: AMGN

Addition of OTEZLA Strengthens Amgen (AMGN)'s Long-Standing Expertise in Inflammation

MISSISSAUGA, ON, Feb. 12, 2020 /CNW/ - Today, Amgen Canada Inc.

https://www.amgen.ca/

https://www.otezla.com/

https://seekingalpha.com/symbol/AMGN

Otezla® (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis. Otezla is a prescription medicine approved for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Vir Biotechnology Identifies Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Wed February 12, 2020 8:30 AM|GlobeNewswire|About: VIR

SAN FRANCISCO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)

https://www.vir.bio/

https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-identifies-two-antibodies-bind-spike-protein

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

https://seekingalpha.com/symbol/VIR

Vir Biotechnology Identifies Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2 02/12/20 at 8:30 AM EST SAN FRANCISCO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR)

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

Wed February 12, 2020 6:45 AM|Business Wire|About: MRK

KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigator’s choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin)

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

https://clinicaltrials.gov/ct2/show/NCT02819518

https://www.businesswire.com/news/home/20200212005254/en/

https://www.merck.com/clinical-trials/index.html

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Lisocabtagene Maraleucel (liso-cel)

tucatinib in combination with trastuzumab and capecitabine

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

Thu February 13, 2020 6:59 AM|Business Wire|About: BMY

https://www.businesswire.com/news/home/20200213005238/en/

https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma U.S. FDA set a target action date of August 17, 2020 Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T cells to support a BLA to date Liso-cel is a CD19-directed CAR T-cell product with a defined composition of CAR+ viable T cells consisting of purified CD8+ and CD4+ T cells THURSDAY, FEBRUARY 13, 2020 6:59 AM EST PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY)

tucatinib in combination with trastuzumab and capecitabine

Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Thu February 13, 2020 8:00 AM|Business Wire|About: SGEN

https://www.nejm.org/doi/full/10.1056/NEJMoa1914609?query=featured_home

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

https://clinicaltrials.gov/ct2/show/NCT03975647?term=tucatinib&draw=3

https://investor.seattlegenetics.com/press-releases/news-details/2019/Initial-Results-from-MOUNTAINEER-Trial-Show-Antitumor-Activity-of-Tucatinib-Combination-in-HER2-Positive-Metastatic-Colorectal-Cancer/default.aspx

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

https://www.clinicaltrials.gov/ct2/show/NCT03043313?term=MOUNTAINEER&draw=2&rank=1

https://www.seattlegenetics.com/

https://www.businesswire.com/news/home/20200213005275/en/

Herceptin (trastuzumab)

https://www.herceptin.com/

https://seekingalpha.com/symbol/SGEN

Tucatinib is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, colorectal, and gastric cancers. Between 15% and 20% of breast cancers cases worldwide are HER2-positive.

ADXS-PSA in combination with KEYTRUDA®

tucatinib in combination with trastuzumab and capecitabine

Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium

Thu February 13, 2020 8:00 AM|GlobeNewswire|About: ADXS

Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care

Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA®

PRINCETON, N.J., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS)

https://advaxis.com/

https://advaxis.com/clinical-trials/

About KEYNOTE-046
KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA® (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC.

https://seekingalpha.com/symbol/ADXS

ADXS-PSA is under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer, and is in clinical development for the treatments of metastatic castration-resistant prostate cancer (mCRPC).

Seeking Biotech Alpha February 2020 Insight

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC

Tue February 11, 2020 8:00 AM|PR Newswire|About: ALPMY, PFE

TOKYO and NEW YORK, Feb. 11, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (PFE)

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

https://clinicaltrials.gov/ct2/show/NCT02003924

https://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf

https://www.astellas.com/en/

https://seekingalpha.com/symbol/MDVN

https://www.pfizer.com/

https://www.prnewswire.com/news-releases/xtandi-enzalutamide-demonstrates-significant-improvement-in-overall-survival-in-phase-3-prosper-trial-of-patients-with-nmcrpc-301002463.html

https://www.pfizer.com/news/press-release/press-release-detail/xtandi_enzalutamide_demonstrates_significant_improvement_in_overall_survival_in_phase_3_prosper_trial_of_patients_with_nmcrpc

https://seekingalpha.com/symbol/ALPMY

https://seekingalpha.com/symbol/PFE

XTANDI is a prescription medicine used to treat men with prostate cancer that: no longer responds to a hormone therapy or surgical treatment to lower testosterone OR has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone

PB2452

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

PhaseBio Announces European Regulatory Update for PB2452

Tue February 11, 2020 8:00 AM|GlobeNewswire|About: PHAS

PB2452 granted PRIME Designation by the European Medicines Agency

PhaseBio receives written scientific advice confirming PB2452 clinical development plan

In Phase 1 and Phase 2a clinical trials, PB2452 provided immediate and sustained reversal of the antiplatelet effects of ticagrelor

MALVERN, Pa. and SAN DIEGO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc (PHAS). (Nasdaq: PHAS)

https://phasebio.com/

https://phasebio.com/pipeline/

The European Medicines Agency has granted PRIME status to PhaseBio Pharmaceuticals' (PHAS -2.1%) PB2452 as a reversal agent of AstraZeneca's (AZN) anticoagulant Brilinta (ticagrelor).

https://seekingalpha.com/symbol/PHAS

Our lead product candidate, PB2452, is a novel ticagrelor reversal agent and we are currently conducting a Phase 2b trial in older (ages 50-64) and elderly (ages 65-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin.

FDA clears Varian Medical's Ethos therapy

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

FDA clears Varian Medical's Ethos therapy

Varian Receives FDA 510(k) Clearance for Ethos Therapy

Tue February 11, 2020 8:15 AM|PR Newswire|About: VARPR Newswire

PALO ALTO, Calif., Feb. 11, 2020 /PRNewswire/ -- Varian (VSEA) (NYSE: VAR)

https://www.varian.com/products/adaptive-therapy/ethos

https://www.varian.com/

https://www.varian.com/about-varian/newsroom/press-releases/varian-receives-fda-510k-clearance-ethos-therapy

https://seekingalpha.com/symbol/VAR

https://www.prnewswire.com/news-releases/varian-receives-fda-510k-clearance-for-ethos-therapy-301002481.html

Ethos™ therapy is a comprehensive, revolutionary new therapy that is patient-centric and personalized—from initial planning to on-couch adaptation and treatment monitoring.

JAK Inhibitor Baricitinib

Johnson & Johnson’s Response to the 2019-nCoV Crisis

FDA clears Varian Medical's Ethos therapy

Lilly and Incyte Announce Positive Top-Line Results from the North American Phase 3 Study (BREEZE-AD5) of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate- to Severe Atopic Dermatitis

Tue February 11, 2020 6:24 PM|GlobeNewswire|About: LLY

Study met the primary endpoint of at least 75% improvement of skin inflammation and key secondary endpoints
Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis
Results from this study conducted in North America continue to support regulatory submissions

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company (LLY) and Incyte

https://www.lilly.ca/en/index.aspx

https://www.incyte.com/

https://www.fibrogen.com/

roxadustat

Johnson & Johnson’s Response to the 2019-nCoV Crisis

FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

Tue February 11, 2020 5:00 PM|GlobeNewswire|About: AZN, FGEN

SAN FRANCISCO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (FGEN)

https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-us-fda-acceptance-new-drug-application

https://seekingalpha.com/symbol/FGEN

https://seekingalpha.com/symbol/AZN

FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease SAN FRANCISCO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN)

Johnson & Johnson’s Response to the 2019-nCoV Crisis

Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

Tue February 11, 2020 4:30 PM|PR Newswire|About: JNJPR Newswire

NEW BRUNSWICK, N.J., Feb. 11, 2020 /PRNewswire/ -- Johnson & Johnson (JNJ) today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.

https://www.jnj.com/johnson-johnson-launches-multi-pronged-response-to-coronavirus-global-public-health-threat

https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-collaboration-with-us-department-of-health-and-human-services-to-fight-influenza

https://www.jnj.com/coronavirus

https://www.prnewswire.com/news-releases/johnson--johnson-announces-collaboration-with-us-department-of-health--human-services-to-accelerate-development-of-a-potential-novel-coronavirus-vaccine-301003251.html

Johnson & Johnson’s Response to the 2019-nCoV Crisis

Seeking Biotech Alpha February 2020 Insight

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Exelixis Announces Encouraging Results for Cabozantinib in Combination With Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

Mon February 10, 2020 5:00 PM|Business Wire|About: EXEL

Data from the COSMIC-021 trial will be presented on Thursday, February 13, 2020 at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

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

Exelixis Further Expands Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid TumorsPDF Version

– Based on continued encouraging efficacy and safety data, metastatic castration-resistant prostate cancer cohort further expanded to 130 patients –

– Initial data to be presented on February 13 at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020) in San Francisco, CA –

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 7, 2020-- Exelixis, Inc. (NASDAQ: EXEL)

https://clinicaltrials.gov/ct2/show/NCT03170960

https://www.exelixis.com/

https://www.businesswire.com/news/home/20200210005731/en/

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination

https://ir.exelixis.com/news-releases/news-release-details/exelixis-further-expands-prostate-cancer-cohort-phase-1b-cosmic

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination

https://www.tecentriq.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.

Intuitive Acquires Orpheus Medical

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

Mon February 10, 2020 4:01 PM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG)

https://www.intuitive.com/en-us

https://seekingalpha.com/symbol/ISRG

Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals February 10, 2020 at 4:01 PM EST

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

Mon February 10, 2020 5:00 PM|PR Newswire|About: ALPMY, SGEN

PR Newswire

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ -- Seattle Genetics, Inc. (SGEN) (Nasdaq: SGEN) and Astellas Pharma Inc. (ALPMF)

https://www.seattlegenetics.com/

https://www.astellas.com/

https://www.prnewswire.com/news-releases/seattle-genetics-and-astellas-announce-updated-results-from-phase-1b2-trial-of-padcev-enfortumab-vedotin-ejfv-in-combination-with-immune-therapy-pembrolizumab-as-investigational-first-line-treatment-for-advanced-bladder-cancer-301002275.html

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

https://seekingalpha.com/symbol/SGEN

Enfortumab vedotin is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).

MET inhibitor capmatinib (INC280)

myChoice® CDx test to help identify women with advanced ovarian cancer

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

Tue February 11, 2020 1:18 AM|PR Newswire

- Substantial unmet need exists among patients with METex14 mutated advanced NSCLC as there are no treatment options approved to specifically target this aggressive form of lung cancer

- Capmatinib review expected to be completed within six months

PR Newswire

EAST HANOVER, N.J., Feb. 11, 2020 /PRNewswire

https://www.prnewswire.com/news-releases/novartis-announces-met-inhibitor-capmatinib-inc280-the-first-potential-treatment-for-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review-301002504.html

https://seekingalpha.com/symbol/NVS

https://www.incyte.com/

https://www.businesswire.com/news/home/20200210005864/en/

https://seekingalpha.com/symbol/INCY

Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer

Tue February 11, 2020 1:17 AM|Business Wire|About: INCY

The U.S. Food and Drug Administration (FDA) Priority Review for capmatinib is based on Phase 2 data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1
Novartis has exclusive worldwide development and commercialization rights to capmatinib

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

https://seekingalpha.com/pr/17774676-incyte-announces-acceptance-and-priority-review-of-nda-for-capmatinib-for-advanced-non-small

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review Feb 11, 2020 FDA Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1 Substantial unmet need exists among patients with METex14 mutated advanced NSCLC as there are no treatment options approved to specifically target this aggressive form of lung cancer Capmatinib review expected to be completed within six months Basel, February 11, 2020

myChoice® CDx test to help identify women with advanced ovarian cancer

Myriad Submits sPMA for myChoice® CDx with Lynparza® in First-Line Maintenance Therapy in Advanced Ovarian Cancer

Tue February 11, 2020 7:05 AM|GlobeNewswire|About: MYGN

https://www.nejm.org/doi/full/10.1056/NEJMoa1911361

https://myriad.com/

https://www.globenewswire.com/news-release/2020/02/11/1982928/0/en/Myriad-Submits-sPMA-for-myChoice-CDx-with-Lynparza-in-First-Line-Maintenance-Therapy-in-Advanced-Ovarian-Cancer.html

https://seekingalpha.com/symbol/MYGN

https://myriad.com/products-services/precision-medicine/mychoice-cdx/

Myriad Submits sPMA for myChoice® CDx with Lynparza® in First-Line Maintenance Therapy in Advanced Ovarian Cancer

TALTZ® (ixekizumab)

myChoice® CDx test to help identify women with advanced ovarian cancer

Health Canada has approved TALTZ® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Tue February 11, 2020 6:45 AM|GlobeNewswire|About: LLY

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly Canada

https://www.lilly.ca/en/index.aspx

Taltz is an injectable medicine used to treat adults: With moderate to severe plaque psoriasis. It is for people who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). With active psoriatic arthritis. With active ankylosing spondylitis.

Seeking Biotech Alpha February 2020 Insight

BTK (Bruton's tyrosine kinase) inhibitor (SAR442168)

KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy

BTK (Bruton's tyrosine kinase) inhibitor (SAR442168)

Sanofi : Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

Thu February 6, 2020 1:00 AM|GlobeNewswire|About: SNY

Sanofi (SNY) brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

Sanofi’s BTK inhibitor will potentially be first disease-modifying therapy to address sources of multiple sclerosis (MS) damage in the brain
Sanofi to initiate four Phase 3 clinical trials in relapsing and progressive forms of MS

PARIS – February 6, 2020

https://clinicaltrials.gov/ct2/show/NCT03889639

SAR442168 is an investigational, oral, brain-penetrant, selective small-molecule inhibitor of BTK. SAR442168 has shown BTK binding as well as cerebrospinal fluid exposure in Phase 1 studies. The efficacy and safety of SA442168 has not been reviewed by any regulatory authority.

Sanofi obtained global rights to develop and commercialize SAR442168 under a license agreement with Principia Biopharma, Inc.

February 06 2020 Sanofi : Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

EYLEA® (aflibercept) Injection

KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy

BTK (Bruton's tyrosine kinase) inhibitor (SAR442168)

EYLEA® (aflibercept) Injection Reduced Risk of Developing Vision-Threatening Events by 75% After Two Years in Patients with Diabetic Retinopathy

Sat February 8, 2020 5:00 PM|PR Newswire|About: REGN

https://www.regeneron.com/

https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-reduced-risk-developing-vision

https://www.regeneron.com/sites/default/files/EYLEA_FPI.pdf

https://www.prnewswire.com/news-releases/eylea-aflibercept-injection-reduced-risk-of-developing-vision-threatening-events-by-75-after-two-years-in-patients-with-diabetic-retinopathy-301001515.html

https://seekingalpha.com/symbol/REGN

EYLEA® (aflibercept) Injection 2 mg (0.05mL) is a prescription medicine approved for the treatment of patients with Wet Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy

U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

Mon February 10, 2020 8:30 AM|Business Wire|About: GILD

https://www.kitepharma.com/

https://www.businesswire.com/news/home/20200210005203/en/

February 10, 2020 U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma -- If Approved, Kite Could be First Company with Multiple Commercialized CAR T Therapies -- SANTA MONICA, Calif.--(BUSINESS WIRE)--Feb. 10, 2020-- Kite, a Gilead Company (Nasdaq: GILD)

Leronlimab (PRO 140)

mRNA-1273 to prevent novel coronavirus (2019-nCoV)

KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy

CytoDyn Files a Phase 2 Basket Trial with Leronlimab (PRO 140) for Treatment of All Solid Tumor Cancers

Thu February 6, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, Feb. 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/newsroom/press-releases/detail/382/cytodyn-files-a-phase-2-basket-trial-with-leronlimab-pro

https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-modernizes-clinical-trials-master-protocols-february-26-2019-issue

FDA Fast Track Designation for Leronlimab

mRNA-1273 to prevent novel coronavirus (2019-nCoV)

Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates

Mon February 10, 2020 5:11 PM|Business Wire|About: AZN, MRK, MRNA

Phase 2 CMV vaccine dose-confirmation study more than sixty percent enrolled

mRNA-1189 to prevent infectious mononucleosis and Epstein-Barr virus (EBV) infection

mRNA-1345 to prevent respiratory syncytial virus (RSV) disease in young children, with the intent to combine with mRNA-1653 to create a pediatric respiratory vaccine against RSV, hMPV and PIV3

mRNA-1273 to prevent novel coronavirus (2019-nCoV) disease, in collaboration with the National Institutes of Health; physical manufacturing of first batch complete, awaiting analytical testing

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

https://www.businesswire.com/news/home/20200210005823/en/

https://seekingalpha.com/symbol/MRNA

https://cepi.net/

https://www.modernatx.com/

Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates February 10, 2020 at 5:11 PM EST PDF Version Phase 2 CMV vaccine dose-confirmation study more than sixty percent enrolled mRNA-1189 to prevent infectious mononucleosis and Epstein-Barr virus (EBV) infection mRNA-1345 to prevent respiratory syncytial virus (RSV) disease in young children, with the intent to combine with mRNA-1653 to create a pediatric respiratory vaccine against RSV, hMPV and PIV3 mRNA-1273 to prevent novel coronavirus (2019-nCoV) disease, in collaboration with the National Institutes of Health; physical manufacturing of first batch complete, awaiting analytical testing CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 10, 2020-- Moderna, Inc. (Nasdaq: MRNA),

DARZALEX® (Daratumumab)

mRNA-1273 to prevent novel coronavirus (2019-nCoV)

Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Mon February 10, 2020 4:30 PM|PR NewswirePR Newswire

RARITAN, N.J., Feb. 10, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

CANDOR is an Amgen-sponsored study and is co-funded by Janssen Research & Development, LLC. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.

https://www.janssen.com/janssen-announces-submission-us-fda-new-darzalexr-daratumumab-based-combination-regimen-patients