Seeking Biotech Alpha DECEMBER 2019 Insight

REVLIMID® (lenalidomide)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID® in Relapsed or Refractory Indolent Lymphoma

Sun December 22, 2019 6:00 PM|GlobeNewswire|About: BGNE

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal

https://media2.celgene.com/content/uploads/revlimid-pi.pdf

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-0?loc=US

REVLIMID® (lenalidomide)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy for Duchenne Muscular Dystrophy, SRP-9001

Mon December 23, 2019 1:00 AM|GlobeNewswire|About: SRPT

– Roche obtains the exclusive right to launch and commercialize SRP-9001 outside the United States –

– At closing, Sarepta will receive an upfront payment of $1.15 billion, comprising $750 million in cash and $400 million in Sarepta stock, priced at $158.59 per share of common stock –

– Additionally, Sarepta is eligible to receive up to $1.7 billion in regulatory and sales milestones, plus royalties on net sales –

– Sarepta will continue to be responsible for clinical development and manufacturing of SRP-9001 with global clinical development costs shared equally with Roche –

– Sarepta will host a conference call on Monday, Dec. 23 at 08:30 a.m. ET –

CAMBRIDGE, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)

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

Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy for Duchenne Muscular Dystrophy, SRP-9001 December 23, 2019 at 1:00 AM EST

Valoctocogene roxaparvovec

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

Valoctocogene roxaparvovec

BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A

Mon December 23, 2019 8:36 AM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.biomarin.com/

https://www.prnewswire.com/news-releases/biomarin-submits-biologics-license-application-to-us-food-and-drug-administration-for-valoctocogene-roxaparvovec-to-treat-hemophilia-a-300978804.html

Valoctocogene Roxaparvovec (BMN 270) for Hemophilia A Valoctocogene roxaparvovec is gene therapy designed for the treatment of Hemophilia A. Hemophilia A is a genetic disease caused by the deficiency of clotting factor VIII. It is the most common type of hemophilia and occurs much more frequently in males; incidence is estimated at 1 in 4,000-5,000 male births.

UBRELVYTM (ubrogepant)

Valoctocogene roxaparvovec

Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults

Mon December 23, 2019 3:13 PM|PR Newswire|About: AGN

-- With just one dose, UBRELVY™ can quickly eliminate patients' migraine pain and their most bothersome migraine symptom compared with placebo at two hours --

-- Pain freedom (or elimination of pain) is a recent, more stringent standard of efficacy set forth by the FDA for acute treatment of migraine --

-- UBRELVY™ demonstrated low rates of side effects in clinical trials --

PR Newswire

DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (AGN)

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

https://www.prnewswire.com/news-releases/allergan-receives-us-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults-300979082.html

http://www.ubrelvy.com/

Allergan gets FDA approval for oral migraine treatment

Dec. 23, 2019 3:23 PM ET|About: Allergan plc (AGN)|By: Liz Kiesche, SA News Editor

https://seekingalpha.com/news/3528262-allergan-gets-fda-approval-for-oral-migraine-treatment

Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults -- UBRELVY™ is the first and only oral CGRP receptor antagonist (gepant) FDA-approved for the acute treatment of migraine -- -- With just one dose, UBRELVY™ can quickly eliminate patients’ migraine pain and their most bothersome migraine symptom compared with placebo at two hours -- -- Pain freedom (or elimination of pain) is a recent, more stringent standard of efficacy set forth by the FDA for acute treatment of migraine -- -- UBRELVY™ demonstrated low rates of side effects in clinical trials -- DUBLIN, IRELAND – December 23, 2019- Allergan plc (NYSE: AGN)

Tremfya (guselkumab)

UBRELVYTM (ubrogepant)

Tremfya (guselkumab)

DECEMBER 27, 2019 / 3:02 AM / UPDATED 5 HOURS AGO

China regulator approves imports of J&J's Tremfya

BEIJING (Reuters) - China has approved imports of Johnson & Johnson’s Tremfya (guselkumab)

Johnson & Johnson's Tremfya gets China approval

Dec. 27, 2019 7:36 AM ET|About: Johnson & Johnson (JNJ)|By: Brandy Betz, SA News Editor

https://seekingalpha.com/news/3528535-johnson-johnsons-tremfya-gets-china-approval

TREMFYA® 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 phototherapy (treatment using ultraviolet or UV light).

Tislelizumab

UBRELVYTM (ubrogepant)

Tremfya (guselkumab)

China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Classical Hodgkin’s Lymphoma Who Have Received at Least Two Prior Therapies

Fri December 27, 2019 10:30 PM|GlobeNewswire|About: BGNE

Second BeiGene (BGNE)-discovered drug to receive regulatory approval, first in China
Tislelizumab is an anti–PD-1 antibody specifically designed to minimize binding to FcγR on macrophages

BEIJING, China and CAMBRIDGE, Mass., Dec. 27, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd.,

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

Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies,

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

China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Classical Hodgkin’s Lymphoma Who Have Received at Least Two Prior Therapies December 27, 2019 at 10:30 PM EST

Seeking Biotech Alpha DECEMBER 2019 Insight

ERVEBO® (Ebola Zaire Vaccine, Live)

Revlimid® (lenalidomide) in Combination with Rituximab

ERVEBO® (Ebola Zaire Vaccine, Live)

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

Thu December 19, 2019 7:25 PM|PR Newswire

FDA OKs Merck Ebola vaccine

Dec. 19, 2019 10:04 PM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3527618-fda-oks-merck-ebola-vaccine

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Fri December 20, 2019 7:15 AM|Business Wire|About: MRK

https://seekingalpha.com/pr/17734317-merck-announces-fda-approval-for-ervebo-ebola-zaire-vaccine-live

https://www.merck.com/index.html

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live) Action Represents Another Milestone for the Global Partnership Against Ebola Friday, December 20, 2019 7:15 am EST

KEYTRUDA® (pembrolizumab)

Revlimid® (lenalidomide) in Combination with Rituximab

ERVEBO® (Ebola Zaire Vaccine, Live)

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

Fri December 20, 2019 6:45 AM|Business Wire|About: MRK

KEYTRUDA Now Approved for Six Cancer Types Plus Microsatellite Instability-High (MSI-H) Tumors in Japan

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

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

https://www.businesswire.com/news/home/20191220005101/en/

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

KEYTRUDA Now Approved for Six Cancer Types Plus Microsatellite Instability-High (MSI-H) Tumors in Japan

Friday, December 20, 2019 6:45 am EST

https://www.merck.com/index.html

https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-approved-japan-three-new-first-line-indications-

New indications for Merck's Keytruda OK'd in Japan

Dec. 20, 2019 6:51 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3527675-new-indications-for-mercks-keytruda-okd-in-japan

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.

Revlimid® (lenalidomide) in Combination with Rituximab

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

Fri December 20, 2019 6:59 AM|Business Wire|About: BMY

Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

Approval was based on data from the phase 3 AUGMENT study, which showed statistically significant improvements in median progression-free survival in patients treated with the combination over rituximab-placebo monotherapy

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

https://www.businesswire.com/news/home/20191220005238/en/

https://www.rituxan.com/

https://www.revlimid.com/

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

CATEGORY:

CORPORATE/FINANCIAL NEWSFRIDAY, DECEMBER 20, 2019 6:59 AM EST

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-european-commission-approval-rev

A chemotherapy-free treatment combination REVLIMID® in combination with a rituximab product, is used to treat adult patients who have previously been treated for follicular lymphoma (FL). REVLIMID® in combination with a rituximab product, is used to treat adult patients who have previously been treated for marginal zone lymphoma (MZL). Please see full Prescribing Information, including BOXED WARNINGS.

Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir)

J & J Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

Revlimid® (lenalidomide) in Combination with Rituximab

China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment

Fri December 20, 2019 8:30 AM|Business Wire|About: GILD

– Vosevi Provides a New Option for People with HCV Who Have Not Achieved Cure with Prior Direct-Acting Antiviral Treatment –

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

https://www.businesswire.com/news/home/20191220005282/en/

https://www.vosevi.com/

December 20, 2019

China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment

https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/china-national-medical-products-administration-approves-vosevi-sofosbuvir-velpatasvir-and-voxilaprevir-for-people-with-chronic-hepatitis-c-infecti

VOSEVI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated) who have previously been treated with a Hep C regimen containing an NS5A inhibitor.

ENHERTU (fam-trastuzumab deruxtecan-nxki)

J & J Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

ENHERTU (fam-trastuzumab deruxtecan-nxki) Approved in the US for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens

Fri December 20, 2019 6:04 PM|Business Wire|About: AZN

Accelerated Approval of AstraZeneca and Daiichi Sankyo’s ENHERTU based on the DESTINY-Breast01 trial that showed clinically meaningful and durable responses

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Daiichi Sankyo Company, Limited (Daiichi Sankyo)

http://www.enhertupi.com/

https://seekingalpha.com/pr/17734865-fda-approves-new-treatment-option-for-patients-her2-positive-breast-cancer-who-progressed-on

http://www.enhertupi.com/

https://www.businesswire.com/news/home/20191220005575/en/

ENHERTU (fam-trastuzumab deruxtecan-nxki) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens PUBLISHED 20 December 2019 Accelerated Approval of AstraZeneca and Daiichi Sankyo’s ENHERTU based on the DESTINY-Breast01 trial that showed clinically meaningful and durable responses AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)

J & J Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

Johnson & Johnson Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

Fri December 20, 2019 4:01 PM|PR NewswirePR Newswire

NEW BRUNSWICK, N.J., Dec. 20, 2019 /PRNewswire/ -- Johnson & Johnson announced today the acquisition of TARIS Biomedical LLC (TARIS)

https://www.janssen.com/

https://tarisbiomedical.com/

https://www.prnewswire.com/news-releases/johnson--johnson-acquires-taris-biomedical-with-focus-on-transforming-the-treatment-of-bladder-cancer-300978469.html

https://tarisbiomedical.com/pipeline/

Johnson & Johnson Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer Dec 20, 2019 United States Novel Drug Delivery Technology Strengthens Targeted Oncologic Therapy Approach NEW BRUNSWICK, N.J., Dec. 20, 2019 -- Johnson & Johnson announced today the acquisition of TARIS Biomedical LLC (TARIS),

Seeking Biotech Alpha DECEMBER 2019 Insight

SPRAVATO™ (Esketamine) Nasal Spray

Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

SPRAVATO™ (Esketamine) Nasal Spray

BUSINESS WIRE

SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder

BEERSE, Belgium 19DEC2019

J&J's Spravato OK'd in Europe for treatment-resistant depression

Dec. 19, 2019 6:35 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3527331-j-and-js-spravato-okd-in-europe-for-treatment-resistant-depression

SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults. SPRAVATO™ is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO™ is safe or effective as an anesthetic medicine.

PADCEV™ (enfortumab vedotin-ejfv)

Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

SPRAVATO™ (Esketamine) Nasal Spray

FDA Grants Accelerated Approval to Astellas' and Seattle Genetics' PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer

Wed December 18, 2019 7:49 PM|PR Newswire|About: ALPMY, SGEN

- PADCEV is the First Treatment Approved for Locally Advanced or Metastatic Urothelial Cancer Following Treatment with Platinum-based Chemotherapy and a PD-1 or PD-L1 Inhibitor -

PR Newswire

TOKYO and BOTHELL, Wash., Dec. 18, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (SGEN)

https://www.prnewswire.com/news-releases/fda-grants-accelerated-approval-to-astellas-and-seattle-genetics-padcev-enfortumab-vedotin-ejfv-for-people-with-locally-advanced-or-metastatic-urothelial-cancer-the-most-common-type-of-bladder-cancer-300977283.html

Seattle Genetics to Host Conference Call and Webcast on December 19, 2019 to Discuss PADCEVTM(enfortumab vedotin-ejfv) Approval

12/18/2019

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) will host a conference call and webcast on Thursday, December 19, 2019 to discuss the U.S. Food and Drug Administration approval of PADCEVTM (enfortumab vedotin-ejfv).

https://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-to-Host-Conference-Call-and-Webcast-on-December-19-2019-to-Discuss-PADCEVTM-enfortumab-vedotin-ejfv-Approval/default.aspx

https://www.astellas.com/us/innovation/r-and-d

https://www.fda.gov/news-events/press-announcements/fda-approves-new-type-therapy-treat-advanced-urothelial-cancer

PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, offers access and reimbursement support to help patients access PADCEVTM (enfortumab vedotin-ejfv). PADCEV Support Solutions provides information regarding patient healthcare coverage, financial assistance information that may be available to help patients with financial needs, and coding and billing information for PADCEV. To speak with a dedicated access specialist, please call us at 1‑888‑402‑0627. We are available Monday–Friday, 8:30 am–8:00 pm ET. PADCEVTM is a trademark jointly owned by Agensys, Inc. and Seattle Genetics, Inc.

Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

Catalyst Biosciences Announces Global License and Collaboration Agreement to Develop Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

Thu December 19, 2019 8:00 AM|GlobeNewswire|About: BIIB, CBIOGlobeNewswire

SOUTH SAN FRANCISCO, Calif., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO)

https://www.catalystbiosciences.com/

http://ir.catalystbiosciences.com/events-and-presentations/upcoming-events?c=254141&p=irol-calendar

https://seekingalpha.com/symbol/CBIO

Pipeline

filgotinib, an investigational, oral, selective JAK1 inhibitor

Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

Thu December 19, 2019 4:30 PM|Business Wire|About: GILD

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

https://www.businesswire.com/news/home/20191219005768/en/

December 19, 2019

Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/gilead-submits-filgotinib-new-drug-application-to-us-food-and-drug-administration-under-priority-review-for-rheumatoid-arthritis-treatment

Filgotinib

ABP 798, Biosimilar Candidate To Rituxan® (rituximab)

filgotinib, an investigational, oral, selective JAK1 inhibitor

VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%)

Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration

Thu December 19, 2019 4:44 PM|PR Newswire|About: AGN, AMGNPR Newswire

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ -- Amgen (AMGN) and Allergan plc (AGN). (NYSE:AGN)

Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration

Filing for ABP 798 Supported by Two Comparative Clinical Studies

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN)

https://www.amgen.com/media/news-releases/2019/12/amgen-and-allergan-submit-biologics-license-application-for-abp-798-biosimilar-candidate-to-rituxan-rituximab-to-us-food-and-drug-administration/

https://www.allergan.com/

https://www.prnewswire.com/news-releases/amgen-and-allergan-submit-biologics-license-application-for-abp-798-biosimilar-candidate-to-rituxan-rituximab-to-us-food-and-drug-administration-300978011.html

Your source for biosimilars information: from the basics, to the latest research, to regulatory updates.

VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%)

filgotinib, an investigational, oral, selective JAK1 inhibitor

VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%)

Bausch + Lomb Announces VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%) Now Publicly Covered Under the Ontario Public Drug Benefit (ODB) Program

Thu December 19, 2019 4:01 PM|Canada Newswire|About: BHC

LAVAL, QC, Dec. 19, 2019 /CNW Telbec/ - Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (BHC) (TSX: BHC)

https://www.formulary.health.gov.on.ca/formulary/

https://www.bausch.ca/en-ca/

https://www.bauschhealth.ca/

VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, is used to lower intraocular (eye) pressure in patients with open-angle glaucoma or ocular hypertension

Seeking Biotech Alpha DECEMBER 2019 Insight

BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab)

U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy

Wed December 18, 2019 10:30 AM|Business Wire|About: PFE

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

https://www.arraybiopharma.com/documents/Braftovi_Prescribing_information.pdf

ERBITUX is an approved treatment for people with certain advanced colorectal and head and neck cancers.

https://www.erbitux.com/

https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_accepts_and_grants_priority_review_to_snda_for_braftovi_encorafenib_in_combination_with_erbitux_cetuximab_braftovi_doublet_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_after_prior

https://www.businesswire.com/news/home/20191218005517/en/

What is BRAFTOVI + MEKTOVI? BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

RINVOQ™ (upadacitinib)

BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab)

AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Wed December 18, 2019 10:50 AM|PR Newswire|About: ABBV

- In five pivotal Phase 3 studies, RINVOQ™(upadacitinib) met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis[1-6]

- RINVOQ, given alone or with csDMARDs, demonstrated improved rates of low disease activity (DAS28-CRP≤3.2) and clinical remission (DAS28-CRP<2.6) compared to placebo, MTX or adalimumab[1-6]

- Nearly 3 million people in Europe are living with rheumatoid arthritis, the majority of whom don't achieve remission[7,8]

PR Newswire

NORTH CHICAGO, Ill., Dec. 18, 2019 /PRNewswire/ -- AbbVie (ABBV)

https://www.ema.europa.eu/en

https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-rinvoq-upadacitinib-for-treatment-adults-with-moderate-to-severe-active-rheumatoid-arthritis.htm

https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-rinvoq-upadacitinib-for-the-treatment-of-adults-with-moderate-to-severe-active-rheumatoid-arthritis-300976990.html

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.

Tucatinib in combination with trastuzumab and capecitabine

BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab)

Tucatinib in combination with trastuzumab and capecitabine

Seattle Genetics Announces U.S. FDA Grants Breakthrough Therapy Designation for Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer

Wed December 18, 2019 8:00 AM|Business Wire|About: SGEN

- Designation Based on Positive Pivotal HER2CLIMB Trial Evaluating Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer; Data were Presented at 2019 SABCS and Published in the New England Journal of Medicine -

- New Drug Application Submission to U.S. FDA Expected by First Quarter of 2020 -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN)

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

https://www.seattlegenetics.com/

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.

https://www.seattlegenetics.com/pipeline/tucatinib

https://www.businesswire.com/news/home/20191218005170/en/

Seattle Genetics' tucatinib nabs accelerated review in U.S. for HER2+ breast cancer

Dec. 18, 2019 10:26 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3527131-seattle-genetics-tucatinib-nabs-accelerated-review-in-u-s-for-her2-breast-cancer

Emgality® (galcanezumab-gnlm)

CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Tucatinib in combination with trastuzumab and capecitabine

Lilly Announces the Launch of TRIUMPH, the First, Long-Term, Real-World Evidence Study of Emgality® (galcanezumab-gnlm)

Wed December 18, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Dec. 18, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

http://uspl.lilly.com/emgality/emgality.html#pi

https://investor.lilly.com/news-

releases/news-release-details/lilly-announces-launch-triumph-first-long-term-real-world

https://www.prnewswire.com/news-releases/lilly-announces-the-launch-of-triumph-the-first-long-term-real-world-evidence-study-of-emgality-galcanezumab-gnlm-300976517.html

Important Facts About Emgality® (em-GAL-it-ē) injection. Also known as galcanezumab-gnlm. Emgality is a prescription medicine used in adults for: The preventive treatment of migraine. The medicine (120 mg) comes in a prefilled pen or syringe and is taken once a month. The treatment of episodic cluster headache. The medicine (300 mg) comes in three (100 mg) prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.

VENCLEXTA® With Rituximab

CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia (CLL)

Wed December 18, 2019 2:56 PM|Canada Newswire|About: ABBV

Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA)i, Quebec is the first province to reimburse the combination treatment.
VENCLEXTA® + rituximab is a regimen that includes a targeted oral agent that should be continued for two years after initial five weeks ramp-up phase.

MONTREAL, Dec. 18, 2019 /CNW/ - AbbVie (ABBV)

http://www.abbvie.ca/

http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf

RITUXAN® (rituximab) is a prescription medicine used to treat adults with:

Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.

https://www.rituxan.com/patient/what-is-rituxan.html

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.

https://www.venclexta.com/

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.

CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA

Wed December 18, 2019 4:16 PM|Business Wire|About: BMY

BLA submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma

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

https://www.businesswire.com/news/home/20191218005737/en/

ristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA BLA submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma CATEGORY: CORPORATE/FINANCIAL NEWS WEDNESDAY, DECEMBER 18, 2019 4:16 PM EST

Seeking Biotech Alpha DECEMBER 2019 Insight

Lilly to Integrate Dexcom CGM into Personalized Diabetes Management System

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP)

Lilly to Integrate Dexcom CGM into Personalized Diabetes Management System

Mon December 16, 2019 6:45 AM|PR Newswire|About: DXCM, LLY

INDIANAPOLIS, Dec. 16, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) has announced a global commercialization agreement to integrate DexCom, Inc. (DXCM)

https://www.lillydiabetes.com/

https://www.facebook.com/LillyDiabetesUS/

https://www.prnewswire.com/news-releases/lilly-to-integrate-dexcom-cgm-into-personalized-diabetes-management-system-300975004.html

https://www.dexcom.com/

https://seekingalpha.com/news/3526343-lilly-to-use-dexcom-cgms-in-automated-insulin-dosing-system

https://investor.lilly.com/news-releases/news-release-details/lilly-integrate-dexcom-cgm-personalized-diabetes-management

Zero Fingersticks! Discover the Dexcom G6 CGM System We’ll help make knowledge your superpower with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The Dexcom G6 eliminates fingersticks for calibration, diabetes treatment decisions and diabetes management.*

First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP)

Lilly to Integrate Dexcom CGM into Personalized Diabetes Management System

First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness

Mon December 16, 2019 8:05 AM|Business Wire|About: ABMD

DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed (NASDAQ: ABMD)

http://www.abiomed.com/impella

https://www.impella.com/

http://www.abiomed.com/

https://www.businesswire.com/news/home/20191216005332/en/

Impella® The World's Smallest Heart Pump

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP)

BioMarin Announces Positive Final Results from Placebo-Controlled Phase 3 Data in Children with Achondroplasia Treated with Vosoritide

Mon December 16, 2019 8:15 AM|PR Newswire|About: BMRN

Pre-submission Meetings with Health Authorities Planned for H1 2020 to Discuss Marketing Applications

PR Newswire

SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.prnewswire.com/news-releases/biomarin-announces-positive-final-results-from-placebo-controlled-phase-3-data-in-children-with-achondroplasia-treated-with-vosoritide-300975084.html

BioMarin's vosoritide successful in late-stage achondroplasia study

Dec. 16, 2019 11:37 AM ET|About: BioMarin Pharmaceutica... (BMRN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526501-biomarins-vosoritide-successful-in-late-stage-achondroplasia-study

https://investors.biomarin.com/2019-12-16-BioMarin-Announces-Positive-Final-Results-from-Placebo-Controlled-Phase-3-Data-in-Children-with-Achondroplasia-Treated-with-Vosoritide

Vosoritide (BMN 111) for Achondroplasia Vosoritide is designed for the treatment of achondroplasia, the most common form of dwarfism

XTANDI® (enzalutamide)

Sangamo updates on pipeline at R&D Day

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP)

XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer

Mon December 16, 2019 6:00 PM|PR Newswire|About: ALPMY, PFEPR Newswire

NEW YORK and TOKYO, Dec. 16, 2019 /PRNewswire/ -- Pfizer Inc. (PFE) and Astellas Pharma Inc. (ALPMF) (TSE: 4503

https://clinicaltrials.gov/ct2/show/NCT02677896

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

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

https://www.prnewswire.com/news-releases/xtandi-enzalutamide-approved-by-us-fda-for-the-treatment-of-metastatic-castration-sensitive-prostate-cancer-300975657.html

FDA OKs expanded use of Astellas and Pfizer's Xtandi

Dec. 16, 2019 10:00 PM ET|About: Astellas Pharma Inc. (ALPMF)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526667-fda-oks-expanded-use-of-astellas-and-pfizers-xtandi

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

belantamab mafodotin (GSK2857916)

Sangamo updates on pipeline at R&D Day

Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma

Mon December 16, 2019 6:36 PM|Canada Newswire|About: GSK

Overall response rate (ORR) of 31% with 2.5 mg/kg regimen and no new safety signals in heavily pre-treated patient population who were refractory to an immunomodulatory drug and a proteasome inhibitor, and were refractory or intolerant to an anti-CD38 antibody
Data published in The Lancet Oncology highlight the potential of belantamab mafodotin for patients with multiple myeloma whose disease has progressed
GSK confirms submission of a Biologics License Application to the US Food and Drug Administration

LONDON, Dec. 16, 2019 /CNW/ -- GlaxoSmithKline plc (GSK)

https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916

https://www.prnewswire.com/news-releases/pivotal-dreamm-2-study-demonstrated-a-clinically-meaningful-overall-response-rate-with-belantamab-mafodotin-gsk2857916-for-patients-with-relapsedrefractory-multiple-myeloma-300975664.html

Glaxo antibody-drug conjugate shows treatment benefit in refractory MM

Dec. 17, 2019 7:16 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526697-glaxo-antibody-drug-conjugate-shows-treatment-benefit-in-refractory-mm

16 December 2019 Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma

Sangamo updates on pipeline at R&D Day

Sangamo Highlights Advancements in Genomic Medicine Pipeline and Expanded R&D and Manufacturing Capabilities at R&D Day

Tue December 17, 2019 6:45 AM|Business Wire|About: SGMO

IND transfer to Pfizer for SB-525 hemophilia A gene therapy is substantially completed; Pfizer is advancing SB-525 into a Phase 3 registrational study in 2020
At R&D Day, Sangamo is detailing global capabilities across clinical science, operations, product development, and manufacturing
Company is also introducing new gene therapy and genome regulation programs for clinical development, including several addressing highly prevalent diseases, with IND targets in 2021 and 2022
Live webcast today at 8am Eastern Time

BRISBANE, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (SGMO)

Sangamo updates on pipeline at R&D Day

Dec. 17, 2019 7:39 AM ET|About: Sangamo Therapeutics, ... (SGMO)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526715-sangamo-updates-on-pipeline-r-and-d-day

https://www.sangamo.com/

https://www.businesswire.com/news/home/20191217005318/en/

https://investor.sangamo.com/news-releases/news-release-details/sangamo-highlights-advancements-genomic-medicine-pipeline-and

Sangamo Therapeutics R&D Day Tuesday, December 17, 2019

Seeking Biotech Alpha DECEMBER 2019 Insight

VASCEPA® (ICOSAPENT ETHYL)

dispersible-tablet (DT) formulation of dolutegravir (DTG)

EXALT™ Model D Single-Use Duodenoscope

Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce Cardiovascular Risk

Fri December 13, 2019 6:14 PM|PR Newswire|About: AMRN

- Millions of people in the United States qualify as treatment candidates For VASCEPA

- Cardiovascular disease events, including heart attack, stroke and cardiovascular death, occur in the United States every 14 seconds and are economically, physically and emotionally costly

- VASCEPA has been assessed by independent bodies as priced cost effectively as a cardiovascular risk reduction treatment

- VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million

Amarin to host webcast on Monday, December 16 at 7:30 a.m., Eastern Time

PR Newswire

DUBLIN and BRIDGEWATER, N.J., Dec. 13, 2019 /PRNewswire/ -- Amarin Corporation plc (AMRN)

https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups

https://investor.amarincorp.com/news-releases/news-release-details/amarin-receives-fda-approval-vascepar-icosapent-ethyl-reduce

https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf

https://www.vascepa.com/

https://www.prnewswire.com/news-releases/amarin-receives-fda-approval-of-vascepa-icosapent-ethyl-to-reduce-cardiovascular-risk-300974860.html

Home / All posts / HLS Therapeutics has a winner in Vascepa, Stifel says

HLS Therapeutics has a winner in Vascepa, Stifel says

DECEMBER 17, 2019 BY NICK WADDELL

https://www.cantechletter.com/2019/12/hls-therapeutics-has-a-winner-in-vascepa-stifel-says/

Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce Cardiovascular Risk VASCEPA becomes the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment

EXALT™ Model D Single-Use Duodenoscope

dispersible-tablet (DT) formulation of dolutegravir (DTG)

EXALT™ Model D Single-Use Duodenoscope

Boston Scientific Receives FDA Clearance For World's First Single-Use Duodenoscope, EXALT™ Model D

Fri December 13, 2019 1:30 PM|PR Newswire|About: BSXPR Newswire

MARLBOROUGH, Mass., Dec. 13, 2019 /PRNewswire/ -- Boston Scientific Corporation (BSX)

https://www.bostonscientific.com/en-US/Home.html

https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-clearance-for-worlds-first-single-use-duodenoscope-exalt-model-d-300974733.html

EXALTTM Model D Single-Use Duodenoscope Changing the standard of care for ERCP procedures with the world’s first and only single-use, sterile duodenoscope designed to be lightweight, consistent and high-performing.

dispersible-tablet (DT) formulation of dolutegravir (DTG)

13 December 2019

ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV

If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible tablet for children living with HIV - closing the gap between treatment options available for adults and children

Issued: London, UK

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited

ViiV Healthcare files applications for dispersible formulations of dolutegravir

Dec. 13, 2019 6:43 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526102-viiv-healthcare-files-applications-for-dispersible-formulations-of-dolutegravir

https://www.tivicayhcp.com/

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with: other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent

BTK inhibitor BRUKINSA™ (zanubrutinib)

combination =acetyl-CoA carboxylase (ACC) inhibitor firsocostat & nonsteroidal farnesoid X receptor

dispersible-tablet (DT) formulation of dolutegravir (DTG)

BeiGene Announces Results of Phase 3 ASPEN Trial of Zanubrutinib Compared to Ibrutinib for the Treatment of Patients with Waldenström’s Macroglobulinemia

Mon December 16, 2019 7:00 AM|GlobeNewswire|About: BGNE

- Primary Endpoint of Statistical Superiority Related to Deep Response (VGPR or Better) Was Not Met; However, Zanubrutinib Demonstrated More Frequent VGPRs (28.4% vs.19.2% in Overall Population)

- Zanubrutinib Demonstrated Advantages in Safety and Tolerability Compared to Ibrutinib

- ASPEN is the Largest Phase 3 Trial in Waldenström’s Macroglobulinemia and the First Comparative Trial Readout for BTK Inhibitors

- Company to Hold Investor Conference Call and Webcast Today at 8:30 AM ET

CAMBRIDGE, Mass. and BEIJING, China, Dec. 16, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE),

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-results-phase-3-aspen-trial-zanubrutinib?loc=US

http://hkexir.beigene.com/?loc=US

https://www.beigene.com/PDF/BRUKINSAUSPPI.pdf

Zanubrutinib (BGB-3111) — a small molecule inhibitor of Bruton’s tyrosine kinase, or BTK, that is currently being evaluated in a broad late-stage clinical trials program globally, including in China, as a potential monotherapy and in combination with other therapies to treat various B cell malignancies.

BOTOX® (onabotulinumtoxinA)

combination =acetyl-CoA carboxylase (ACC) inhibitor firsocostat & nonsteroidal farnesoid X receptor

BOTOX® (onabotulinumtoxinA) Celebrates 30 Years of Endless Innovation

Mon December 16, 2019 7:00 AM|PR Newswire|About: AGN

-- With more than 100 million vials manufactured worldwide, BOTOX® and BOTOX® Cosmetic remain trusted by physicians --

-- Allergan continues to innovate and provide new treatment options to address patients' needs --

PR Newswire

DUBLIN, Dec. 16, 2019 /PRNewswire/ -- Allergan plc (AGN)

https://www.prnewswire.com/news-releases/botox-onabotulinumtoxina-celebrates-30-years-of-endless-innovation-300974918.html

https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/20190620_BTX-and-BTX-C-Med-Guide-v2-0MG1145.pdf

https://www.allergan.com/

https://www.allergan.com/products/botox-cosmetic

https://www.allergan.com/News/Details/2019/12/BOTOX%20onabotulinumtoxinA%20Celebrates%2030%20Years%20of%20Endless%20Innovation

Indication BOTOX® is a prescription medicine that is injected to prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older. It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

combination =acetyl-CoA carboxylase (ACC) inhibitor firsocostat & nonsteroidal farnesoid X receptor

Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Mon December 16, 2019 8:00 AM|Business Wire|About: GILD

-- Study Primary Endpoint Was Not Met; Improvement in Multiple Measures of Fibrosis and Liver Injury Was Observed with Investigational Firsocostat and Cilofexor --

-- Regimens Were Well Tolerated and Safety Measures Were Consistent with Prior Studies –

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

https://www.gilead.com/

https://www.businesswire.com/news/home/20191216005231/en/

December 16, 2019 Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) -- Study Primary Endpoint Was Not Met; Improvement in Multiple Measures of Fibrosis and Liver Injury Was Observed with Investigational Firsocostat and Cilofexor -- -- Regimens Were Well Tolerated and Safety Measures Were Consistent with Prior Studies – FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 16, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD)

Seeking Biotech Alpha DECEMBER 2019 Insight

VYNDAQEL® (tafamidis 61 mg) and VYNDAQEL® (tafamidis meglumine 20 mg)

Pfizer Receives Positive CHMP Opinion for VYNDAQEL® for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease

Fri December 13, 2019 8:28 AM|Business Wire|About: PFE

—If approved by the European Commission (EC), VYNDAQEL® will be the first pharmacologic therapy in the EU for patients with transthyretin amyloid cardiomyopathy—

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

https://www.businesswire.com/news/home/20191213005202/en/

https://www.pfizer.com/science/drug-product-pipeline

U.S. FDA APPROVES VYNDAQEL® AND VYNDAMAX™ FOR USE IN PATIENTS WITH TRANSTHYRETIN AMYLOID CARDIOMYOPATHY, A RARE AND FATAL DISEASE — First and only medicines approved for patients with either wild-type or hereditary transthyretin amyloid cardiomyopathy — Monday, May 6, 2019 - 6:45am EDT NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE)

Tislelizumab in Combination with Sitravatinib

VYNDAQEL® (tafamidis 61 mg) and VYNDAQEL® (tafamidis meglumine 20 mg)

BeiGene Announces Clinical Data on Investigational Anti-PD-1 Antibody Tislelizumab in Combination with Sitravatinib at European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2019

Fri December 13, 2019 7:00 AM|GlobeNewswire|About: BGNE, MRTXGlobeNewswire

CAMBRIDGE, Mass. and BEIJING, China, Dec. 13, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

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

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-clinical-data-investigational-anti-pd-1?loc=US

Mirati Therapeutics (MRTX)

https://www.mirati.com/pipeline/

BeiGene's tislelizumab combo shows positive action in ovarian cancer

Dec. 13, 2019 8:25 AM ET|About: BeiGene, Ltd. (BGNE)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3526149-beigenes-tislelizumab-combo-shows-positive-action-in-ovarian-cancer

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and we believe it could serve as a key element of our immuno-oncology combination platform. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Erleada (apalutamide)

VYNDAQEL® (tafamidis 61 mg) and VYNDAQEL® (tafamidis meglumine 20 mg)

Jardiance® (empagliflozin)

On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Erleada. The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.

European advisory group backs new use of J&J's Erleada

Dec. 13, 2019 8:04 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526139-european-advisory-group-backs-new-use-of-j-and-js-erleada

https://www.erleada.com/

ERLEADA® (apalutamide) is a prescription medicine used for the treatment of prostate cancer: That has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone OR That has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone It is not known if ERLEADA® is safe and effective in females.

Jardiance® (empagliflozin)

automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration

Jardiance® (empagliflozin)

Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure

Fri December 13, 2019 8:00 AM|PR Newswire|About: LLY

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (LLY)

https://clinicaltrials.gov/ct2/show/NCT03448406?term=EMPERIAL&rank=1

https://clinicaltrials.gov/ct2/show/NCT03448419?term=EMPERIAL&rank=2

https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/Patient%20Info/Jardiance%20Patient%20Information.pdf?DMW_FORMAT=pdf

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

https://www.lillydiabetes.com/

https://www.lilly.com/products

Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure

12/13/2019Download PDF

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)

https://investor.lilly.com/news-releases/news-release-details/boehringer-ingelheim-and-lilly-provide-update-jardiancer-phase

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine)

DARZALEX® (daratumumab)

automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration

CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

Fri December 13, 2019 6:32 AM|GlobeNewswire|About: GMAB

Company Announcement

CHMP issued positive opinion for DARZALEX® in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
Final decision from European Commission expected in the coming months
Opinion based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; December 13, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)

https://www.darzalex.com/

http://www.genmab.com/

European advisory group backs expanded use of J&J's Darzalex

Dec. 13, 2019 7:57 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526131-european-advisory-group-backs-expanded-use-of-j-and-js-darzalex

What is DARZALEX® (daratumumab)? DARZALEX® is a prescription medicine used to treat adults with multiple myeloma: In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple

automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration

PerkinElmer Launches First FDA-Approved Assay Kit to Screen for Duchenne Muscular Dystrophy in Newborns

Fri December 13, 2019 9:20 AM|Business Wire|About: PKI

Available on PerkinElmer’s automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration instead of CK enzyme activity

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (PKI), (NYSE: PKI)

https://newbornscreening.perkinelmer.com/products/gsp_instrument/gsp_neonatal_creatine_kinase_-mm_kit

https://newbornscreening.perkinelmer.com/

https://www.perkinelmer.com/

https://www.businesswire.com/news/home/20191213005240/en/

GSP Neonatal Creatine Kinase -MM kit PerkinElmer’s new assay measures muscle specific creatine kinase in dried blood spots, helping to detect newborns affected by Duchenne Muscular Dystrophy

Seeking Biotech Alpha DECEMBER 2019 Insight

TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib)

TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib) are registered trademarks of Genentech, a member of the Roche Group.

Exelixis Announces Positive Results From IMspire150, the Phase 3 Trial of Atezolizumab Plus Cotellic and Vemurafenib in People With Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma

Fri December 13, 2019 1:02 AM|Business Wire|About: EXEL

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

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

https://www.businesswire.com/news/home/20191212005923/en/

https://www.exelixis.com/

What is COTELLIC? COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, to treat a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene

CYRAMZA® (ramucirumab)

TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib)

CHMP Issues Positive Opinion to Expand CYRAMZA® (ramucirumab) Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Fri December 13, 2019 6:47 AM|PR Newswire|About: LLY

Positive opinion based on Phase 3 RELAY study, which showed significant improvement in progression-free survival

PR Newswire

INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

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

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

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

https://www.lillyoncology.com/

https://www.cyramza.com/

CHMP Issues Positive Opinion to Expand CYRAMZA® (ramucirumab) Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

12/13/2019Download PDFCYRAMZA in combination with erlotinib recommended for approval in the EU for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations
Positive opinion based on Phase 3 RELAY study, which showed significant improvement in progression-free survival

INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

https://investor.lilly.com/news-releases/news-release-details/chmp-issues-positive-opinion-expand-cyramzar-ramucirumab-label

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

Beovu® (brolucizumab)

TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib)

XELJANZ® XR (tofacitinib)

On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Beovu, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD). The applicant for this medicinal product is Novartis Europharm Limited.

European advisory group backs Novartis' brolucizumab for wet AMD

Dec. 13, 2019 7:17 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526114-european-advisory-group-backs-novartis-brolucizumab-for-wet-amd

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

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

Novartis receives positive CHMP opinion for Beovu® (brolucizumab) for the treatment of wet AMD Dec 13, 2019

XELJANZ® XR (tofacitinib)

Tecentriq® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib)

XELJANZ® XR (tofacitinib)

FDA Approves XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

Thu December 12, 2019 5:12 PM|Business Wire|About: PFE

XELJANZ XR provides adult patients living with moderately to severely active UC the first and only once-daily JAK inhibitor for managing their disease

NEW YORK--(BUSINESS WIRE)--

Pfizer Inc. (PFE)

https://labeling.pfizer.com/ShowLabeling.aspx?id=959

https://www.pfizer.com/

https://www.businesswire.com/news/home/20191212005841/en/

FDA OK's extended-release Xeljanz for ulcerative colitis

Dec. 13, 2019 6:50 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3526105-fda-oks-extended-release-xeljanz-for-ulcerative-colitis

What is XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat: Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated Adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated XELJANZ is also used to treat: Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C. XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.

VYONDYS 53™ (golodirsen) Injection

Tecentriq® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib)

Sarepta Therapeutics Announces FDA Approval of VYONDYS 53™ (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53

Thu December 12, 2019 6:19 PM|GlobeNewswire|About: SRPT

-- VYONDYS 53 is Sarepta’s second RNA exon-skipping treatment for DMD approved in the U.S. --

-- Commercial distribution of VYONDYS 53 in the U.S. will commence immediately --

-- Information for patients and clinicians is available at www.SareptAssist.com --

CAMBRIDGE, Mass., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)

https://www.sarepta.com/our-product/sareptassist

https://www.vyondys53.com/Vyondys53_(golodirsen)_Prescribing_Information.pdf

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

Sarepta Therapeutics Announces FDA Approval of VYONDYS 53™ (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53 December 12, 2019 at 6:19 PM EST

Tecentriq® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib)

Genentech Announces Phase III Study Results for Tecentriq Plus Cotellic and Zelboraf in People With Previously Untreated BRAF V600 Mutation-positive Advanced Melanoma

Fri December 13, 2019 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/20191212005920/en/

https://www.gene.com/

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

https://www.gene.com/patients/medicines/zelboraf

https://www.cotellic.com/

TECENTRIQ may work with your immune system to fight cancer

Seeking Biotech Alpha DECEMBER 2019 Insight

LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292

Lilly Opens First Ever Randomized Phase 3 Clinical Trial in Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

Wed December 11, 2019 6:45 AM|PR Newswire|About: LLY

- Trial aims to enroll 400 patients with advanced or metastatic treatment-naïve RET fusion-positive NSCLC

PR Newswire

INDIANAPOLIS, Dec. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

https://www.lillyoncology.com/

https://www.lilly.com/

https://www.prnewswire.com/news-releases/lilly-opens-first-ever-randomized-phase-3-clinical-trial-in-treatment-naive-ret-fusion-positive-non-small-cell-lung-cancer-300972812.html

Lilly Opens First Ever Randomized Phase 3 Clinical Trial in Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer 12/11/2019 Download PDF - LIBRETTO-431 Phase 3 trial to examine selpercatinib (LOXO-292) against standard of care - Trial aims to enroll 400 patients with advanced or metastatic treatment-naïve RET fusion-positive NSCLC INDIANAPOLIS, Dec. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

[fam]-trastuzumab deruxtecan (DS-8201)

LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292

[Fam]-Trastuzumab Deruxtecan Achieved a Tumor Response of 60.9% in Pivotal Phase II HER2-positive Metastatic Breast Cancer Trial

Wed December 11, 2019 8:00 AM|Business Wire|About: AZN

AstraZeneca and Daiichi Sankyo’s [fam]-trastuzumab deruxtecan demonstrated an impressive 14.8-month median duration of response and 16.4-month median progression-free survival

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Daiichi Sankyo Company, Limited (Daiichi Sankyo)

https://www.businesswire.com/news/home/20191211005425/en/

AstraZeneca/Daiichi ADC shows sustained benefit in mid-stage breast cancer study

Dec. 11, 2019 9:19 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3525505-astrazeneca-daiichi-adc-shows-sustained-benefit-in-mid-stage-breast-cancer-study

Trastuzumab deruxtecan achieved a tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial PUBLISHED 11 December 2019 11 December 2019 13:00 GMT AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan demonstrated an impressive 14.8-month median duration of response and 16.4-month median progression-free survival

mavrilimumab, in combination with Yescarta® (axicabtagene ciloleucel)

LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292

mavrilimumab, in combination with Yescarta® (axicabtagene ciloleucel)

Kite and Kiniksa Pharmaceuticals Announce Clinical Collaboration Evaluating Investigational Combination of Yescarta® and Mavrilimumab in Relapsed or Refractory Large B-Cell Lymphoma

Wed December 11, 2019 8:30 AM|Business Wire|About: GILD, KNSA

-- Phase 2 study will Examine the Effect of Mavrilimumab on the Clinical Profile of Yescarta --

SANTA MONICA, Calif., & HAMILTON, Bermuda--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), and Kiniksa Pharmaceuticals, Ltd. (KNSA)

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

https://www.businesswire.com/news/home/20191211005149/en/

mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in combination with Yescarta® (axicabtagene ciloleucel)

https://www.yescartarems.com/

https://www.kitepharma.com/

https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-and-kiniksa-pharmaceuticals-announce-clinical-collaboration-evaluating-investigational-combination-of-yescarta-and-mavrilimumab-in-relapsed-or-r

https://www.kiniksa.com/

YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Sutimlimab, a novel investigational C1s inhibitor,

mavrilimumab, in combination with Yescarta® (axicabtagene ciloleucel)

Sanofi : Positive results presented from pivotal Phase 3 trial of sutimlimab in people with cold agglutinin disease

Tue December 10, 2019 7:30 AM|GlobeNewswire|About: SNY

www.clinicaltrials.gov, study identifier number NCT03347396

https://ml-eu.globenewswire.com/Resource/Download/ff40b2da-8397-43e9-924b-b67d4f4de0cf

https://rarediseases.info.nih.gov/diseases/6130/cold-agglutinin-disease

https://seekingalpha.com/news/3525094-sanofis-sutimlimab-successful-in-late-stage-cold-agglutinin-disease-study

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

allosteric NMDA receptor modulator SAGE-718

Sutimlimab, a novel investigational C1s inhibitor,

allosteric NMDA receptor modulator SAGE-718

Sage Therapeutics to advance Huntington's candidate SAGE-718; shares up 2%

Dec. 10, 2019 11:17 AM ET|About: Sage Therapeutics, Inc. (SAGE)|By: Douglas W. House, SA News Editor

https://www.mayoclinic.org/diseases-conditions/huntingtons-disease/symptoms-causes/syc-20356117

https://www.sagerx.com/

Advancing a Leading Brain Health Portfolio Our differentiated approach to drug discovery and development has allowed us to create a broad portfolio of fully-owned product candidates with the potential for development in a wide range of psychiatric, neurological and related central nervous system (CNS) disorders.

Xolair® (omalizumab)

Sutimlimab, a novel investigational C1s inhibitor,

allosteric NMDA receptor modulator SAGE-718

FDA Accepts Supplemental Biologics License Application for Xolair (omalizumab) for the Treatment of Nasal Polyps

Wed December 11, 2019 1:00 AM|Business Wire|About: RHHBY

– The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids –

– If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E –

– Frequently co-occurring with other respiratory conditions, nasal polyps is a chronic condition and causes a range of symptoms impacting patients’ lives including loss of sense of smell and nasal congestion –

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

https://www.xolair.com/?cid=gne_WE_00000083

https://www.gene.com/

https://www.businesswire.com/news/home/20191210006130/en/

https://seekingalpha.com/news/3525421-fda-accepts-genentechs-sbla-for-xolair

https://www.gene.com/media/press-releases/14830/2019-12-10/fda-accepts-supplemental-biologics-licen

What is XOLAIR? XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat moderate to severe persistent asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

Seeking Biotech Alpha DECEMBER 2019 Insight

EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34

Editas Medicine Announces In Vivo Proof-of-Concept Data for EDIT-301, in Development for the Treatment of Sickle Cell Disease and Beta-Thalassemia

Mon December 9, 2019 6:00 PM|GlobeNewswire|About: EDITGlobeNewswire

CAMBRIDGE, Mass., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (EDIT)

https://www.editasmedicine.com/

EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34+ Cells for the Potential Treatment of SCD

Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34

Amgen Data From Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) To Be Presented During Late-Breaking Session At American Society Of Hematology Annual Meeting

Tue December 10, 2019 7:30 AM|PR Newswire|About: AMGN

37% Reduction in the Risk of Progression or Death Compared to KYPROLIS and Dexamethasone (Kd) in Patients With Relapsed/Refractory Multiple Myeloma

Patients Treated With KdD Achieved Deeper Responses Than Patients Treated With Kd Alone

PR Newswire

THOUSAND OAKS, Calif., Dec. 10, 2019 /PRNewswire/ -- Amgen (AMGN)

https://www.darzalex.com/newly-diagnosed-multiple-myeloma#banner-click

https://www.prnewswire.com/news-releases/amgen-data-from-phase-3-candor-study-combining-kyprolis-carfilzomib-and-darzalex-daratumumab-to-be-presented-during-late-breaking-session-at-american-society-of-hematology-annual-meeting-300971947.html

KYPROLIS® (carfilzomib) is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.

investigational agent CC-486

EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34

investigational agent CC-486

Bristol-Myers Squibb Presents Overall Survival and Safety Data From Pivotal CC-486 Study QUAZAR AML-001

Tue December 10, 2019 7:30 AM|Business Wire|About: BMY

Maintenance treatment with CC-486 resulted in a significant improvement in overall survival compared with placebo for front-line AML patients

CC-486 had a manageable safety profile

Data presented at the 2019 American Society of Hematology (ASH) Annual Meeting

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

https://www.businesswire.com/news/home/20191210005526/en/

https://seekingalpha.com/pr/17723138-bristol-myers-squibb-presents-overall-survival-and-safety-data-from-pivotal-ccminus-486-study

Bristol-Myers Squibb Presents Overall Survival and Safety Data From Pivotal CC-486 Study QUAZAR AML-001 Maintenance treatment with CC-486 resulted in a significant improvement in overall survival compared with placebo for front-line AML patients CC-486 had a manageable safety profile Data presented at the 2019 American Society of Hematology (ASH) Annual Meeting CATEGORY: CORPORATE/FINANCIAL NEWS TUESDAY, DECEMBER 10, 2019 7:30 AM EST $BMY announces #latebreaking pivotal data for investigational maintenance therapy for frontline acute myeloid #leukemia at #ASH19 Tweet this PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today

Kalydeco (ivacaftor)

(bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺)

investigational agent CC-486

EC OKs expanded label for Vertex's Kalydeco

Dec. 10, 2019 7:34 AM ET|About: Vertex Pharmaceuticals... (VRTX)|By: Douglas W. House, SA News Editor

Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) in Infants With Cystic Fibrosis Ages 6 Months to Less Than 12 Months With Certain Mutations in the CFTR Gene

- Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in children this young -

https://www.streetaccount.com/pressrelease.aspx?ticker=VRTX&intraday_id=2692641

What is KALYDECO® (ivacaftor)? KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Talk to your doctor to learn if you have an indicated CF gene mutation.

Accu-Chek SugarView

(bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺)

Roche receives CE Mark for Accu-Chek SugarView app

Dec. 10, 2019 8:24 AM ET|About: Roche Holding AG (RHHBY)|By: Mamta Mayani, SA News Editor

https://www.roche.com/dam/jcr:7dce4f06-1828-4963-ba9a-8dc65660503c/en/10122019-mr-ce-accu-chek-sugarview-en.pdf

Roche receives CE Mark for its Accu-Chek SugarView app Basel, 10 December 2019 Accu-Chek SugarView is the first app that determines blood glucose ranges by taking photos with the smartphone camera without the need of a blood glucose meter. It is designed to help non-insulin-dependent people with type 2 diabetes or pre-diabetes live healthier lives in-between doctors’ visits. Type 2 diabetes is the most common form of diabetes, accounting for around 90 % of all diabetes cases. Roche (SIX: RO, ROG; OTCQX: RHHBY)

(bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺)

XBiotech Announces Agreement to Sell True Human Antibody Bermekimab Targeting IL-1a to Janssen

Sat December 7, 2019 3:05 AM|GlobeNewswire|About: XBITGlobeNewswire

AUSTIN, Texas, Dec. 07, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT)

https://seekingalpha.com/news/3524623-xbiotech-out-licenses-anti-inflammatory-antibody-to-janssen-for-up-to-1_35b

https://clinicaltrials.gov/ct2/show/NCT03496974

http://www.xbiotech.com/

XBiotech is committed to advancing its robust pipeline of potential breakthrough antibody therapies. Each of the Company’s targeted antibody candidates were discovered and developed using XBiotech’s proprietary True Human™ technology.

Seeking Biotech Alpha DECEMBER 2019 Insight

IL-15 Agonist, NKTR-255

Kymriah® (tisagenlecleucel, formerly CTL019)

Yescarta® (Axicabtagene Ciloleucel)

Nektar Therapeutics Announces Presentation of New Preclinical Data for its IL-15 Agonist, NKTR-255, at the American Society of Hematology (ASH) 2019 Annual Meeting

Mon December 9, 2019 10:05 AM|PR Newswire|About: NKTR

SAN FRANCISCO, Dec. 9, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR)

https://www.nektar.com/science/scientific-posters

https://www.nektar.com/

https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-presentation-of-new-preclinical-data-for-its-il-15-agonist-nktr-255-at-the-american-society-of-hematology-ash-2019-annual-meeting-300971422.html

https://www.nektar.com/pipeline/rd-pipeline/nktr-255

Yescarta® (Axicabtagene Ciloleucel)

Kymriah® (tisagenlecleucel, formerly CTL019)

Yescarta® (Axicabtagene Ciloleucel)

Kite and the CIBMTR® Present Positive Findings From Real-World Use of Yescarta® (Axicabtagene Ciloleucel) in Relapsed or Refractory Large B-Cell Lymphoma

Mon December 9, 2019 2:45 PM|Business Wire|About: GILD

-- Post-Marketing Study with a Larger Proportion of Older and More Difficult-to-Treat Patients Demonstrates Comparable Safety and Efficacy Data to ZUMA-1 Pivotal Trial --

-- Results Presented at the American Society of Hematology (ASH) Annual Meeting --

ORLANDO, Fla.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)

https://www.cibmtr.org/Pages/index.aspx

https://www.kitepharma.com/

https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-and-the-cibmtr-present-positive-findings-from-realworld-use-of-yescarta-axicabtagene-ciloleucel-in-relapsed-or-refractory-large-bcell-lymph

https://www.businesswire.com/news/home/20191209005180/en

Kymriah® (tisagenlecleucel, formerly CTL019)

LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel)

Novartis Kymriah® demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting

Mon December 9, 2019 2:50 PM|PR Newswire|About: NVS

https://www.novartis.com/

https://www.novartis.com/news/media-releases/novartis-kymriah-demonstrates-consistent-efficacy-and-safety-outcomes-us-patients-when-used-real-world-setting

https://www.prnewswire.com/news-releases/novartis-kymriah-demonstrates-consistent-efficacy-and-safety-outcomes-in-us-patients-when-used-in-real-world-setting-300971605.html

https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/

KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or is refractory (did not go into remission after receiving other leukemia treatments). It is also used in patients with non-Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment.

LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel)

bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy

LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel)

bluebird bio Presents New Data Demonstrating Long-Term Transfusion Independence and Safety for LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel) at 61st ASH Annual Meeting and Exposition

Mon December 9, 2019 4:30 PM|Business Wire|About: BLUE

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

https://www.businesswire.com/news/home/20191209005708/en/

bluebird bio is conducting clinical studies of investigational gene therapies in four diseases: cerebral adrenoleukodystrophy, relapsed/refractory multiple myeloma, sickle cell disease, and transfusion-dependent β-thalassemia.

Reblozyl® (luspatercept-aamt)

bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy

Reblozyl® (luspatercept-aamt) Studies Evaluating Treatment of Anemia in Rare Blood Diseases Presented at American Society of Hematology (ASH) Annual Meeting

Mon December 9, 2019 4:30 PM|Business Wire|About: BMY, XLRN

Initial results from phase 2 study evaluating an investigational use of luspatercept-aamt in myelofibrosis-associated anemia showed promising clinical activity – companies plan to initiate pivotal, phase 3 study called INDEPENDENCE in 2020

Longer-term follow-up from pivotal phase 3 studies of MEDALIST in MDS-associated anemia and BELIEVE in beta thalassemia-associated anemia showed patients experiencing sustained clinical benefit

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and Acceleron Pharma (XLRN

https://media.celgene.com/content/uploads/reblozyl-pi.pdf

http://acceleronpharma.com/

https://www.businesswire.com/news/home/20191209005174/en/

Reblozyl® (luspatercept-aamt)

bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy

bluebird bio and Bristol-Myers Squibb Present Updated Data from Ongoing Phase 1 Study of BCMA-Targeted CAR T Cell Therapy bb21217 in Relapsed/Refractory Multiple Myeloma at 61st ASH Annual Meeting and Exposition

Mon December 9, 2019 6:15 PM|Business Wire|About: BLUE, BMY

Safety profile consistent with known toxicities of CAR T therapies

CAR T persistence observed in 8/10 evaluable responders at Month 6 and 2/2 evaluable responders at Month 18

CAMBRIDGE, Mass., & PRINCETON, N.J.--(BUSINESS WIRE)--

bluebird bio, Inc. (Nasdaq: BLUE) and Bristol-Myers Squibb (BMY) (NYSE: BMY)

bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy

clinicaltrials.gov using identifier NCT03274219.

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

https://www.businesswire.com/news/home/20191209005754/en/

bluebird bio and Bristol-Myers Squibb Present Updated Data from Ongoing Phase 1 Study of BCMA-Targeted CAR T Cell Therapy bb21217 in Relapsed/Refractory Multiple Myeloma at 61st ASH Annual Meeting and Exposition Safety profile consistent with known toxicities of CAR T therapies CAR T persistence observed in 8/10 evaluable responders at Month 6 and 2/2 evaluable responders at Month 18 CATEGORY: CORPORATE/FINANCIAL NEWS MONDAY, DECEMBER 9, 2019 7:08 PM EST CAMBRIDGE, Mass., & PRINCETON, N.J.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE) and Bristol-Myers Squibb (NYSE: BMY)

Seeking Biotech Alpha DECEMBER 2019 Insight

BRUKINSA™ (Zanubrutinib)

Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

ADCETRIS® (Brentuximab Vedotin)

BeiGene Announces Clinical Data on BRUKINSA™ (Zanubrutinib) at the 61st American Society of Hematology (ASH) Annual Meeting

Sun December 8, 2019 4:45 PM|GlobeNewswire|About: BGNE

Oral presentations on data from two clinical trials in chronic lymphocytic leukemia or small lymphocytic lymphoma

Poster presentation on data from clinical trial of BRUKINSA combined with tislelizumab in B-cell malignancies

CAMBRIDGE, Mass. and BEIJING, China, Dec. 08, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.beigene.com/PDF/BRUKINSAUSPI.pdf

https://www.beigene.com/products

BeiGene Announces Clinical Data on BRUKINSA™ (Zanubrutinib) at the 61st American Society of Hematology (ASH) Annual Meeting December 8, 2019 at 4:45 PM EST

ADCETRIS® (Brentuximab Vedotin)

Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

ADCETRIS® (Brentuximab Vedotin)

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

Mon December 9, 2019 10:00 AM|Business Wire|About: SGEN, TAK

- Four-Year Data Continue to Show Superior Progression-Free Survival of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma with 31 Percent Reduction in the Risk of Progression or Death -

- Additional Analysis from ECHELON-2 Phase 3 Clinical Trial Evaluating ADCETRIS Plus CHP Chemotherapy Also Featured at ASH Annual Meeting -

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.seattlegenetics.com/products/adcetris-us

https://www.takeda.com/newsroom/newsreleases/2019/seattle-genetics-and-takeda-announce-additional-analyses-of-adcetris-brentuximab-vedotin-echelon-1-and-echelon-2-phase-3-clinical-trials-at-the-2019-ash-annual-meeting/

https://www.seattlegenetics.com/

https://www.businesswire.com/news/home/20191209005142/en/

What is ADCETRIS? ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 cHL: Adult patients with newly diagnosed Stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy (adriamycin, vinblastine, and dacarbazine) Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Previously untreated sALCL or other CD30-expressing PTCL: Adult patients with newly diagnosed systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with chemotherapy (cyclophosphamide, doxorubicin, and prednisone) Relapsed sALCL: Adult patients with sALCL after at least 1 combination chemotherapy treatment fails Relapsed pcALCL or CD30-expressing MF: Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body)

Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

Mon December 9, 2019 9:00 AM|PR Newswire|About: AMGN

New Location Will Strengthen R&D Presence in South San Francisco and Provide Flexibility for Future Growth

PR Newswire

THOUSAND OAKS, Calif., Dec. 9, 2019 /PRNewswire/ -- Amgen (AMGN) today announced the signing of a lease with BioMed Realty (BMR)

https://www.prnewswire.com/news-releases/amgen-selects-location-for-rd-facility-in-the-south-san-francisco-biotechnology-hub-300971372.html

Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub Amgen Signs Lease With Biomed Realty for New Gateway of Pacific Campus Facility New Location Will Strengthen R&D Presence in South San Francisco and Provide Flexibility for Future Growth THOUSAND OAKS, Calif., Dec. 9, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

Flublok® Quadrivalent (Influenza Vaccine)

ADYNOVATE ® [Antihemophilic Factor (Recombinant), PEGylated] & FEIBA® [Anti-Inhibitor Coagulant Comp

Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

Sanofi awarded $226 million by US government to expand pandemic influenza preparedness

Mon December 9, 2019 8:30 AM|PR Newswire|About: SNYPR Newswire

SWIFTWATER, Pa., Dec. 9, 2019 /PRNewswire/ -- Sanofi Pasteur, the vaccines global business unit of Sanofi (SNY)

https://www.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf

https://www.prnewswire.com/news-releases/sanofi-awarded-226-million-by-us-government-to-expand-pandemic-influenza-preparedness-300971002.html

FLUBLOK® QUADRIVALENT INFLUENZA VACCINE

ADYNOVATE ® [Antihemophilic Factor (Recombinant), PEGylated] & FEIBA® [Anti-Inhibitor Coagulant Comp

Takeda Demonstrates Its Long-Standing Commitment to Advancing Treatments for Rare Bleeding Disorders with Studies Highlighting Real-World Evidence and Investigational Gene Therapy at ASH 2019

Mon December 9, 2019 10:00 AM|Business Wire|About: TAK

- Key learnings from real-world data are applied as Takeda (TKPHF) continues to evolve its hematology portfolio, advancing treatment for the bleeding disorders community

- Pre-clinical scientific studies demonstrate potential opportunities to improve upon adeno-associated virus gene therapies for hemophilia and other monogenic diseases

OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“Takeda”),

https://www.shirecontent.com/PI/PDFs/ADYNOVATE_USA_ENG.pdf

https://www.shirecontent.com/PI/PDFs/FEIBA_USA_ENG.pdf

https://www.hemophilia.org/Bleeding-Disorders/Future-Therapies

https://www.businesswire.com/news/home/20191209005481/en/

Latest WFH Statements and Advisories World Hemophilia Day 2020

Vicinium®

ADYNOVATE ® [Antihemophilic Factor (Recombinant), PEGylated] & FEIBA® [Anti-Inhibitor Coagulant Comp

Sesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA

Mon December 9, 2019 7:30 AM|Business Wire|About: SESN

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (SESN),

https://sesenbio.com/

https://sesenbio.com/our-programs/#bladder-cancer

https://www.businesswire.com/news/home/20191209005207/en/

Sesen Bio (SESN) Regulatory Update - Slideshow

Dec. 17, 2019 3:29 PM ET|3 comments | About: Sesen Bio, Inc. (SESN)

https://seekingalpha.com/article/4312984-sesen-bio-sesn-regulatory-update-slideshow

PIPELINE Our fusion protein approach tethers a tumor-targeting antibody fragment to a protein cytotoxic payload to form a single protein molecule designed to selectively and broadly kill cancer cells while minimizing toxicity to healthy cells and to activate the body’s innate immune response system. We are initially focused on the treatment of non-muscle invasive bladder cancer (NMIBC).

Seeking Biotech Alpha DECEMBER 2019 Insight

Eliquis® (apixaban)

lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy

Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer

Sat December 7, 2019 4:00 PM|Business Wire|About: BMY

Results highlighted in two oral presentations at the American Society of Hematology Annual Meeting

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)-- The Bristol-Myers Squibb-Pfizer Alliance

https://www.businesswire.com/news/home/20191207005040/en/

https://www.pfizer.com/

https://www.andexxa.com/

https://news.bms.com/press-release/corporatefinancial-news/findings-released-real-world-data-analysis-eliquis-apixaban-tr

ELIQUIS is a prescription medicine used to: Reduce the risk of stroke and blood clots in people who have atrial fibrillation (AFib), a type of irregular heartbeat, not caused by a heart valve problem. Treat blood clots in the veins of the legs (deep vein thrombosis – DVT) or lungs (pulmonary embolism – PE), and reduce the risk of them occurring again. Reduce the risk of forming a blood clot in the legs (DVT) and lungs (PE) of people who have just had hip or knee replacement surgery.

lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy

Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study

Sat December 7, 2019 2:00 PM|Business Wire|About: BMY

Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses

Generally manageable safety profile with low incidence of CAR T-related severe cytokine release syndrome (CRS) and neurologic events

Data presented at 2019 American Society of Hematology (ASH) Annual Meeting

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

https://www.businesswire.com/news/home/20191207005032/en/

Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses Generally manageable safety profile with low incidence of CAR T-related severe cytokine release syndrome (CRS) and neurologic events Data presented at 2019 American Society of Hematology (ASH) Annual Meeting CATEGORY: CORPORATE/FINANCIAL NEWS SATURDAY, DECEMBER 7, 2019 2:00 PM EST PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY)

Model to Identify Infants at Risk for Infantile Spasms (IS)

lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy

Model to Identify Infants at Risk for Infantile Spasms (IS)

Mallinckrodt Presents Data on a Novel Predictive Model to Identify Infants at Risk for Infantile Spasms (IS) at the 2019 Annual Meeting of the American Epilepsy Society (AES)

Sat December 7, 2019 12:05 PM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, Dec. 7, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

http://www.mallinckrodt.com/

https://www.prnewswire.com/news-releases/mallinckrodt-presents-data-on-a-novel-predictive-model-to-identify-infants-at-risk-for-infantile-spasms-is-at-the-2019-annual-meeting-of-the-american-epilepsy-society-aes-300970934.html

Mallinckrodt Presents Data on a Novel Predictive Model to Identify Infants at Risk for Infantile Spasms (IS) at the 2019 Annual Meeting of the American Epilepsy Society (AES) -- Predictive model based on claims data from 10.8 million infant patients and input from IS medical experts finds strongest predictors for identifying infants at risk for IS include presence of at least two symptoms and a moderate or high severity emergency department visit -- STAINES-UPON-THAMES, United Kingdom, Dec. 7, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK)

Yescarta® (axicabtagene ciloleucel)

JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)chimeric antigen T cell

Model to Identify Infants at Risk for Infantile Spasms (IS)

Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment

Sat December 7, 2019 2:00 PM|Business Wire|About: GILD

-- 47 Percent of Refractory Large B-cell Lymphoma Patients in ZUMA-1 Pivotal Phase 2 Cohorts Were Alive Three Years after a Single Infusion of Yescarta --

-- Separate Cohort Finds Earlier Steroid Use May Reduce Risk of Severe Cytokine Release Syndrome and Neurologic Events --

ORLANDO, Fla.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD),

https://www.businesswire.com/news/home/20191207005016/en/

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

YESCARTA is the first CAR T therapy for adults living with certain types of non-Hodgkin lymphoma. YESCARTA is different from other cancer treatments because it is made from your own white blood cells, which have been modified to recognize and destroy cancer cells.

https://getstartedwithyescarta.com/

December 07, 2019 Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment -- 47 Percent of Refractory Large B-cell Lymphoma Patients in ZUMA-1 Pivotal Phase 2 Cohorts Were Alive Three Years after a Single Infusion of Yescarta -- -- Separate Cohort Finds Earlier Steroid Use May Reduce Risk of Severe Cytokine Release Syndrome and Neurologic Events -- ORLANDO, Fla.--(BUSINESS WIRE)--Dec. 7, 2019-- Kite, a Gilead Company (Nasdaq: GILD),

NINLAROTM (ixazomib) in combination with dexamethasone

JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)chimeric antigen T cell

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis

Sat December 7, 2019 9:30 AM|Business Wire|About: TAK

– Oral Presentation at the American Society of Hematology (ASH) Annual Meeting on December 7, 2019 –

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

https://clinicaltrials.gov/ct2/show/NCT01659658

https://www.ema.europa.eu/en/documents/product-information/ninlaro-epar-product-information_en.pdf

https://www.takeda.com/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/ninlaro/ninlaro-pm-en-non-annotated_26july2018.pdf

https://www.takeda.com/

https://www.businesswire.com/news/home/20191207005007/en/

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis December 7, 2019 – Oral Presentation at the American Society of Hematology (ASH) Annual Meeting on December 7, 2019 Cambridge, Mass. and Osaka, Japan, December 7, 2019 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)

JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)chimeric antigen T cell

Janssen Presents Initial Results for BCMA CAR-T Therapy JNJ-4528 Showing Early, Deep and High Responses in the Treatment of Relapsed or Refractory Multiple Myeloma

Sat December 7, 2019 7:30 AM|PR NewswirePR Newswire

ORLANDO, Fla., Dec. 7, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://clinicaltrials.gov/ct2/show/NCT03548207

https://www.janssen.com/

http://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/testing.html

https://www.prnewswire.com/news-releases/janssen-presents-initial-results-for-bcma-car-t-therapy-jnj-4528-showing-early-deep-and-high-responses-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma-300970960.html

Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma Dec 06, 2019 United States Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory multiple myeloma Initial results from CARTITUDE-1 study to premiere at the American Society of Hematology Annual Meeting RARITAN, N.J., Dec. 6, 2019 -- The Janssen Pharmaceutical Companies of Johnson & Johnso

Seeking Biotech Alpha DECEMBER 2019 Insight

investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB

Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas

Sat December 7, 2019 9:00 AM|Business Wire|About: RHHBY

– Mosunetuzumab data to be presented at the American Society of Hematology 2019 Annual Meeting Plenary Scientific Session demonstrate durable complete responses in people with relapsed or refractory non-Hodgkin’s lymphoma –

– Preliminary safety and efficacy data for CD20-TCB support potential of combination approaches with anti-CD20 therapies –

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

https://www.gazyva.com/

https://www.businesswire.com/news/home/20191207005029/en/

https://seekingalpha.com/pr/17721334-genentech-announces-new-data-on-novel-cd20-cd3-bispecific-cancer-immunotherapies-in-people

https://www.gene.com/

https://seekingalpha.com/news/3524627-bluebird-bios-lentiglobin-gene-therapy-shows-significant-effect-in-scd-study

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III or IV follicular lymphoma (FL) in adults who have not had previous FL treatment. GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment. GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab)

investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB

Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

Sat December 7, 2019 2:00 PM|Business Wire|About: SGEN

- Additional Analysis in Phase 2 Trial of ADCETRIS plus OPDIVO in Patients with Frontline Hodgkin Lymphoma Aged 60 Years and Older -

- Two-Year Follow-up Results from Phase 1/2 Trial in Relapsed Hodgkin Lymphoma -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)

https://www.businesswire.com/news/home/20191207005021/en/

https://www.seattlegenetics.com/

https://www.adcetris.com/

Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting 12/07/2019 - Additional Analysis in Phase 2 Trial of ADCETRIS plus OPDIVO in Patients with Frontline Hodgkin Lymphoma Aged 60 Years and Older - - Two-Year Follow-up Results from Phase 1/2 Trial in Relapsed Hodgkin Lymphoma - BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN)

HGB-206 Study of LentiGlobin™ Gene Therapy

investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB

XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor

bluebird bio Presents New Data from Ongoing Phase 1/2 HGB-206 Study of LentiGlobin™ Gene Therapy for Sickle Cell Disease (SCD) at 61st ASH Annual Meeting and Exposition

Sat December 7, 2019 2:00 PM|Business Wire|About: BLUE

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

https://www.bluebirdbio.com/

https://www.businesswire.com/news/home/20191207005044/en/

XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor

IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor

Xenon Pharmaceuticals Provides Updates on Partnered Neurology Pipeline Programs at the 2019 American Epilepsy Society (AES) Annual Meeting

Sat December 7, 2019 8:45 AM|GlobeNewswire|About: NBIX, XENE

Overview of Clinical Stage XEN901 and Related Patient Survey to be Presented in the “Genetic Epilepsies – Updates in the Science and Diagnosis” Exhibit in Room 318-319 on Sunday, December 8th

Pre-Clinical Work Suggests Selective Sodium Channel Inhibitors that Reduce Action Potential Firing in Excitatory Neurons, While Sparing Inhibitory Interneurons, May Provide Promising Drug Profile

BURNABY, British Columbia, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (XENE)

https://www.xenon-pharma.com/product-pipeline/xen901-for-epilepsy/

XEN901 FOR EPILEPSY

IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Sat December 7, 2019 7:33 AM|PR Newswire|About: ABBV

- New integrated analysis of up to six years of follow-up from RESONATE™ and RESONATE-2 studies (abstract #3054) demonstrated improved results with earlier IMBRUVICA use in CLL patients new to treatment

- Data featured at the 2019 American Society of Hematology (ASH) Annual Meeting further supports IMBRUVICA as the most comprehensively studied Bruton's tyrosine kinase inhibitor, with 10 FDA approvals and 170,000 patients treated worldwide

PR Newswire

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)

seeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotech

Seeking Biotech Alpha DECEMBER 2019 Insight

LYNPARZA® (olaparib)

AZD0466 (DEP® Bcl2/xL conjugate)

AZD0466 (DEP® Bcl2/xL conjugate)

LYNPARZA (Olaparib) Approved in the US as a 1st-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic Cancer

AZD0466 (DEP® Bcl2/xL conjugate)

AZD0466 (DEP® Bcl2/xL conjugate)

AZD0466 (DEP® Bcl2/xL conjugate)

Starpharma: Commencement of Phase 1 Trial for AZD0466 Utilising DEP® Delivery Technology

Commencement of phase 1 trial for AZD0466 utilising DEP®

selpercatinib, LOXO-292

AZD0466 (DEP® Bcl2/xL conjugate)

VASCEPA® (ICOSAPENT ETHYL)

Lilly Opens Phase 3 Clinical Trial in RET-Mutant Medullary Thyroid Cancer

- Randomized trial will examine selpercatinib against standard of care in 400 patients with advanced or metastatic treatment-naïve RET-mutant medullary thyroid cancer

VASCEPA® (ICOSAPENT ETHYL)

Alimta® (pemetrexed for injection) vitamin regimen patent

VASCEPA® (ICOSAPENT ETHYL)

HLS Therapeutics Announces Health Canada Approval for Vascepa® to Reduce the Risk of Cardiovascular Events

CV benefit claim for Amarin's Vascepa OK'd in Canada; shares up 3%

Alimta® (pemetrexed for injection) vitamin regimen patent

Alimta® (pemetrexed for injection) vitamin regimen patent

Alimta® (pemetrexed for injection) vitamin regimen patent

U.S. District Court Rules in Favor of Lilly in Alimta Vitamin Regimen Patent Lawsuit

U.S. District Court Rules in Favor of Lilly in Alimta Vitamin Regimen Patent Lawsuit

Valoctocogene Roxaparvovec

Alimta® (pemetrexed for injection) vitamin regimen patent

Alimta® (pemetrexed for injection) vitamin regimen patent

BioMarin Announces New England Journal of Medicine Publishes 3 Years of Follow-up Data in Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A

Completely Eliminated Prophylactic Factor VIII Use in 6e13 vg/kg and 4e13 vg/kg Doses

2nd Publication in NEJM on Valoctocogene Roxaparvovec

Seeking Biotech Alpha DECEMBER 2019 Insight

REVLIMID® (lenalidomide)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID® in Relapsed or Refractory Indolent Lymphoma

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy for Duchenne Muscular Dystrophy, SRP-9001

Valoctocogene roxaparvovec

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

Valoctocogene roxaparvovec

BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A

UBRELVYTM (ubrogepant)

UBRELVYTM (ubrogepant)

Valoctocogene roxaparvovec

Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults

-- With just one dose, UBRELVY™ can quickly eliminate patients' migraine pain and their most bothersome migraine symptom compared with placebo at two hours --

-- Pain freedom (or elimination of pain) is a recent, more stringent standard of efficacy set forth by the FDA for acute treatment of migraine --

-- UBRELVY™ demonstrated low rates of side effects in clinical trials --

Allergan gets FDA approval for oral migraine treatment

Tremfya (guselkumab)

UBRELVYTM (ubrogepant)

Tremfya (guselkumab)

China regulator approves imports of J&J's Tremfya

Johnson & Johnson's Tremfya gets China approval

Tislelizumab

UBRELVYTM (ubrogepant)

Tremfya (guselkumab)

China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Classical Hodgkin’s Lymphoma Who Have Received at Least Two Prior Therapies

Tislelizumab

Seeking Biotech Alpha DECEMBER 2019 Insight

ERVEBO® (Ebola Zaire Vaccine, Live)

Revlimid® (lenalidomide) in Combination with Rituximab

ERVEBO® (Ebola Zaire Vaccine, Live)

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

FDA OKs Merck Ebola vaccine

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

KEYTRUDA® (pembrolizumab)

Revlimid® (lenalidomide) in Combination with Rituximab

ERVEBO® (Ebola Zaire Vaccine, Live)

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

New indications for Merck's Keytruda OK'd in Japan

Revlimid® (lenalidomide) in Combination with Rituximab

Revlimid® (lenalidomide) in Combination with Rituximab

Revlimid® (lenalidomide) in Combination with Rituximab

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma