Seeking Biotech Alpha February 2020 Insight

CABOMETYX® (cabozantinib)

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.

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/

https://seekingalpha.com/symbol/BMY

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)

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

https://seekingalpha.com/symbol/LLY

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)

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)

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/

https://seekingalpha.com/symbol/GILD

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)

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

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.merck.com/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://seekingalpha.com/symbol/MRK

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%

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

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

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

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://www.novartis.com/

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)

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

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)

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/

https://seekingalpha.com/symbol/RHHBY

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://seekingalpha.com/symbol/RHHBY

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)

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://www.janssen.com/

https://www.jnj.com/

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

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

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

https://seekingalpha.com/symbol/JNJ

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)

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.merck.com/index.html

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)

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/

https://seekingalpha.com/symbol/BMY

https://www.opdivo.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.

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)

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

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

https://seekingalpha.com/symbol/MRK

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)

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

https://seekingalpha.com/symbol/BMY

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®

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

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

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

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://seekingalpha.com/symbol/LLY

https://seekingalpha.com/symbol/JNJ

roxadustat

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://www.fibrogen.com/

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.jnj.com/

https://www.janssen.com/

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®)

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

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)

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.novartis.com/

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)

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

https://seekingalpha.com/symbol/LLY

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

EXPANDED COLLABORATION WITH HHS TO DEVELOP ANTIBODY TREATMENTS FOR NEW CORONAVIRUS

February 4, 2020 at 9:00 AM EST Back

REGENERON ANNOUNCES EXPANDED COLLABORATION WITH HHS TO DEVELOP ANTIBODY TREATMENTS FOR NEW CORONAVIRUS

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

Tue February 4, 2020 9:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN)

https://www.prnewswire.com/news-releases/regeneron-announces-expanded-collaboration-with-hhs-to-develop-antibody-treatments-for-new-coronavirus-300998140.html

August 12, 2019 at 10:01 AM EDT Back

PALM EBOLA CLINICAL TRIAL STOPPED EARLY AS REGENERON'S REGN-EB3 THERAPY SHOWS SUPERIORITY TO ZMAPP IN PREVENTING EBOLA DEATHS

TARRYTOWN, N.Y., Aug. 12, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

https://seekingalpha.com/symbol/REGN

https://www.regeneron.com/technology

VELOCISUITE®

VelociMouse® is a breakthrough technology that enables the immediate generation of genetically altered mice directly from modified embryonic stem cells, thereby avoiding the need to breed multiple generations. This technology has dramatically shortened the time needed to engineer genetically modified mice, while at the same time reducing costs and improving precision.

https://newsroom.regeneron.com/news-releases/news-release-details/palm-ebola-clinical-trial-stopped-early-regenerons-regn-eb3

https://seekingalpha.com/pr/17768295-regeneron-announces-expanded-collaboration-hhs-to-develop-antibody-treatments-for-new

VelociMouse® is a breakthrough technology that enables the immediate generation of genetically altered mice directly from modified embryonic stem cells, thereby avoiding the need to breed multiple generations. This technology has dramatically shortened the time needed to engineer genetically modified mice, while at the same time reducing costs and improving precision.

Fully Implantable Left Ventricular Assist System (FILVAS)

Abbott's In-Development Fully Implantable Heart Pump System Earns FDA's Breakthrough Device Designation

Tue February 4, 2020 9:00 AM|PR Newswire|About: ABT

ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ -- Abbott (ABT)

https://www.abbott.com/isi.html

https://www.abbott.com/

https://www.prnewswire.com/news-releases/abbotts-in-development-fully-implantable-heart-pump-system-earns-fdas-breakthrough-device-designation-300998058.html

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

https://seekingalpha.com/symbol/ABT

https://abbott.mediaroom.com/2020-02-04-Abbotts-In-Development-Fully-Implantable-Heart-Pump-System-Earns-FDAs-Breakthrough-Device-Designation

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. We focus on innovative technologies that can improve the way doctors treat people with vascular diseases, heart arrhythmias (irregular heartbeats) and diseases of the heart’s valves.

BioMotiv and Bristol-Myers Squibb Announce the Launch of Anteros Pharmaceuticals

Tue February 4, 2020 7:00 AM|Business Wire|About: BMY

CLEVELAND & NEW YORK--(BUSINESS WIRE)-- BioMotiv, a mission-driven drug development accelerator associated with The Harrington Project for discovery and development, that advances breakthrough discoveries from research institutions into therapeutics, and Bristol-Myers Squibb Company (BMY) today announced the launch of Anteros Pharmaceuticals

https://www.biomotiv.com/news-posts/2019/9/4/biomotiv-and-bristol-myers-squibb-form-strategic-partnership

https://www.businesswire.com/news/home/20200204005078/en/

https://www.biomotiv.com/

https://www.biomotiv.com/news-posts/2020/2/4/biomotiv-and-bristol-myers-squibb-announce-the-launch-of-anteros-pharmaceuticals

https://www.biomotiv.com/portfolio

https://seekingalpha.com/symbol/BMY

Under the terms of the venture, BMY will contribute intellectual property, data and reagents for a series of small molecules against an undisclosed mechanism. BioMotiv, working with Yale University, will be responsible for R&D. Once Anteros nominates a preclinical candidate, BMY will have the option to acquire Anteros from BioMotiv under pre-agreed terms

Portfolio BioMotiv BioMotiv-BMS

RINVOQ™ (upadacitinib)

RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

Wed February 5, 2020 8:45 AM|PR Newswire|About: ABBV

- The 30 mg dose of RINVOQ achieved superiority to adalimumab in terms of ACR20 response at week 12, whereas both doses achieved non-inferiority versus adalimumab[1]

- Both doses of RINVOQ also significantly inhibited radiographic progression at week 24 compared to placebo[1]

- Significantly more patients receiving either dose of RINVOQ achieved PASI 75 at week 16 compared to placebo[1]

- The safety profile of RINVOQ was consistent with previously reported results across indications, with no new safety risks detected[1,2]

PR Newswire

NORTH CHICAGO, Ill., Feb. 5, 2020 /PRNewswire/ -- AbbVie (ABBV)

https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-meets-primary-and-key-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis-300999462.html

https://www.rxabbvie.com/pdf/humira.pdf?_ga=2.11852404.1718545564.1580836838-223150130.157991395

https://www.abbvie.com/

https://www.abbvie.com/our-science/pipeline.html

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1)

https://clinicaltrials.gov/ct2/show/NCT03104400?cond=Psoriatic+Arthritis&lead=abbvie&phase=2&draw=2&rank=4

https://seekingalpha.com/symbol/ABBV

RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.

SKYRIZI™ (risankizumab)

AbbVie's SKYRIZI™ Now Publicly Reimbursed in Ontario, Alberta, Saskatchewan and Quebec for the Treatment of Moderate to Severe Plaque Psoriasis

Thu February 6, 2020 6:00 AM|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
SKYRIZI™ is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan and Quebec.
Ontario lists SKYRIZI™ on its provincial formulary effective January 31, 2020.
Alberta lists SKYRIZI™ on its provincial formulary effective February 01, 2020.
Saskatchewan lists SKYRIZI™ on its provincial formulary effective February 01, 2020.
Quebec lists SKYRIZI™ on its provincial formulary effective February 05, 2020.

MONTREAL, Feb. 6, 2020 /CNW/ - AbbVie (ABBV)

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31713-6/fulltext

https://abbviecare.ca/

http://www.abbvie.ca/

https://www.abbvie.com/

https://www.skyrizi.com/

https://seekingalpha.com/symbol/ABBV

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).

risdiplam, investigational, orally administered survival motor neuron-2 (SMN-2) splicing modifier

Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy

Thu February 6, 2020 5:00 AM|Business Wire|About: RHHBY

– First placebo-controlled trial to include adults with SMA demonstrates risdiplam improved or stabilized motor function –

– Medically-meaningful and statistically significant results in primary and key secondary endpoints –

– Pivotal SUNFISH Part 2 study population represents broad, real-world spectrum of people living with SMA –

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

https://www.businesswire.com/news/home/20200206005333/en/

https://www.gene.com/scientists/oncology

https://seekingalpha.com/symbol/RHHBY

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

Roche scores FDA priority review for risdiplam, threatening Biogen and Novartis SMA meds by Eric Sagonowsky | Nov 25, 2019 10:35am

Seeking Biotech Alpha February 2020 Insight

testing of remdesivir against 2019-nCoV

Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)

Foster City, Calif., January 31, 2020

"Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir.

Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV.

Biotech

Gilead mulls repositioning failed Ebola drug in China virus

by Nick Paul Taylor | Jan 24, 2020 8:22am

https://www.fiercebiotech.com/biotech/gilead-mulls-repositioning-failed-ebola-drug-china-virus

https://www.wsj.com/articles/u-s-drugmakers-ship-therapies-to-china-seeking-to-treat-coronavirus-11580166592?mod=article_inline

Gilead Sciences Offers Experimental Drug for Coronavirus Treatments, Testing

The U.S. biotech firm has formalized agreement with China to conduct clinical trial of remdesivir

By Joseph WalkerUpdated Jan. 31, 2020 8:33 pm ET

https://www.wsj.com/articles/gilead-sciences-offers-experimental-drug-for-coronavirus-treatments-testing-11580511519

Washington state coronavirus patient treated with investigational, unapproved Ebola drug UPDATED: Fri., Jan. 31, 2020

lopinavir/ritonavir, in combination with flu drug oseltamivir

FEBRUARY 2, 2020 / 8:01 AM / UPDATED 9 HOURS AGO

Cocktail of flu, HIV drugs appears to help fight coronavirus: Thai doctors

Panu Wongcha-um

BANGKOK (Reuters)

The drug treatment includes a mixture of anti-HIV drugs lopinavir and ritonavir, in combination with flu drug oseltamivir in large doses.

lopinavir/ritonavir,

https://www.kaletra.com/

oseltamivir

https://www.tamiflu.com/

The Chinese health authorities have requested supply of Aluvia (lopinavir/ritonavir) as part of the government’s broader efforts to address the coronavirus crisis in China.

PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat)

Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat

Initiating Vaccine Development and Providing Supplies of Antiviral Medicines to China for Investigational Use

NEW BRUNSWICK, N.J., January 29, 2020 – Johnson & Johnson today announced that it is mobilizing resources at its Janssen Pharmaceutical Companies to launch a multi-pronged response to the novel coronavirus (also known as 2019-nCoV or Wuhan coronavirus) outbreak

PREZCOBIX®

https://www.prezcobix.com/home

What You Need to Know About the Latest on the Coronavirus—and a Potential Preventive Vaccine

The coronavirus has made headlines as it has spread from China to other parts of the world. To help stop the global outbreak in its tracks, Johnson & Johnson is already hard at work on a potential preventive vaccine.By Johnson & JohnsonJanuary 28, 2020

https://www.jnj.com/latest-news/what-you-need-to-know-about-coronavirus-and-a-potential-johnson-johnson-vaccine

https://www.janssen.com/

PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine always used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). PREZCOBIX® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. PREZCOBIX® should be taken once daily with food.

REYVOW™ (lasmiditan) C-V 50 mg and 100 mg tablets

Lilly's REYVOW™ (lasmiditan) C-V, the First and Only Medicine in a New Class of Acute Treatment for Migraine (ditan), Now Available for Prescription

Fri January 31, 2020 10:43 AM|PR Newswire|About: LLY

https://www.reyvow.com/

https://www.lilly.com/

https://investor.lilly.com/news-releases/news-release-details/lillys-reyvowtm-lasmiditan-c-v-first-and-only-medicine-new-class

https://www.prnewswire.com/news-releases/lillys-reyvow-lasmiditan-c-v-the-first-and-only-medicine-in-a-new-class-of-acute-treatment-for-migraine-ditan-now-available-for-prescription-300996903.html

Important Facts About REYVOW™ (RAY-vow) tablets. REYVOW is also known as lasmiditan. REYVOW is a prescription medicine for adults. It is used to treat migraine attacks with or without aura when they happen (acute treatment). It is a tablet that you take by mouth. REYVOW is not used to prevent migraine attacks. It is not known if REYVOW is safe and effective in children.

RECARBRIO™ (imipenem, cilastatin, and relebactam)

FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Mon February 3, 2020 6:45 AM|Business Wire|About: MRK

Filing Receives Priority Review

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

https://www.businesswire.com/news/home/20200203005253/en/

https://www.merck.com/product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf

https://www.merckconnect.com/recarbrio/dosing-administration/

https://seekingalpha.com/symbol/MRK

FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Filing Receives Priority Review Monday, February 3, 2020 6:45 am EST

therascreen® PIK3CA RGQ PCR Kit

QIAGEN Launches FFPE and Liquid Biopsy PIK3CA Diagnostics in Europe to Enhance Precision Medicine in Advanced Breast Cancer

Mon February 3, 2020 4:06 PM|Business Wire|About: QGEN

Innovative therascreen® PIK3CA RGQ PCR Kit CE-marked for use in guiding treatment decisions for breast cancer patients
Test detects activating mutations in the phosphatidyl 3-kinase catalytic subunit alpha (PIK3CA) gene
CE-IVD approved therascreen assay will be available to labs in Europe starting immediately

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN N.V. (QGEN)

https://www.businesswire.com/news/home/20200203005744/en/

https://seekingalpha.com/symbol/QGEN

https://www.qiagen.com/us/

https://www.qiagen.com/us/products/diagnostics-and-clinical-research/oncology/therascreen-pik3ca-rgq-pcr-kit-us/?clear=true#orderinginformation

FEB 03 2020

QIAGEN launches FFPE and Liquid Biopsy PIK3CA diagnostics in Europe to enhance precision medicine in advanced breast cancer

• Innovative therascreen® PIK3CA RGQ PCR Kit CE-marked for use in guiding treatment decisions for breast cancer patients
• Test detects activating mutations in the phosphatidylinositol3-kinase catalytic subunit alpha (PIK3CA) gene
• CE-IVD approved therascreen assay will be available to labs in Europe starting immediately

Germantown, Maryland, and Hilden, Germany, February 3, 2019 – QIAGEN N.V. (NYSE: QGEN;

https://corporate.qiagen.com/newsroom/press-releases/2020/20200203_pik3ca_ce_ivd

Oncology Circulating Tumor Cells8 ipsogen Leukemia28 therascreen Solid Tumor12 therascreen PIK3CA RGQ PCR Kit For qualitative detection of 11 mutations in the PIK3CA gene by real-time PCR Reliable detection of clinically relevant mutations in the PIK3CA gene High sensitivity and specificity Results in less than two working days Ready-to-use reagents and reaction mixes Automated data analysis using Rotor-Gene AssayManager v2.1 software

seeking biotech alpha 2/26/2020 the heart of biotech™

seeking biotech alpha 2/26/2020 the heart of biotech™

Seeking Biotech Alpha February 2020 Insight

CABOMETYX® (cabozantinib)

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

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

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

Trulicity® (dulaglutide)

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

Nexletol (bempedoic acid)

Esperion Wins FDA Approval for First Heart Medicine, Nexletol

FDA OKs Esperion's cholesterol med Nexletol

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

YESCARTA® (Axicabtagene Ciloleucel)

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

ALUNBRIG® (brigatinib)

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

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)

Seeking Biotech Alpha February 2020 Insight

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

ruxolitinib cream 0.75% or 1.5%

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

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

FreeStyle Libre system

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

- 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

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

valoctocogene roxaparvovec

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

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

Seeking Biotech Alpha February 2020 Insight

Beovu® (brolucizumab) injection

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

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

VYNDAQEL® (tafamidis)

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

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

- 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

PROCYSBI® (Cysteamine Bitartrate)

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

Our Pipeline

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

Tecentriq® (atezolizumab)

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

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

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

STELARA® (ustekinumab)

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)

First Study to Evaluate Intestinal Ultrasound Monitoring in an Interventional Setting

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

Overview of Crohn's Disease

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)

nelipepimut-S (NPS)

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

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

Opdivo (nivolumab)

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

Remdesivir (GS-5734, Nuc inhibitor)

Second Batch of Experimental Gilead Coronavirus Drug Arrives in Wuhan

Seeking Biotech Alpha February 2020 Insight

OTEZLA® (apremilast)

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

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

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)

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)

Lisocabtagene Maraleucel (liso-cel)