Mon December 30, 2019 6:55 AM|Business Wire|About: AZN
LYNPARZA reduced the risk of disease progression or death by 47% in patients whose disease had not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)
https://www.businesswire.com/news/home/20191230005085/en/
https://www.astrazeneca-us.com/
Sun December 29, 2019 6:07 PM|Business Wire|About: AZN, SPHRY
MELBOURNE, Australia--(BUSINESS WIRE)-- Starpharma today announced that AstraZeneca (AZN)
https://www.businesswire.com/news/home/20191229005009/en/
https://seekingalpha.com/symbol/SPHRY
Dec 30, 2019
https://www.starpharma.com/news/story/commencement-of-phase-1-trial-for-azd0466-utilising-dep
Mon December 30, 2019 6:45 AM|PR Newswire|About: LLY
PR Newswire
INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) today announced the opening of the LIBRETTO-531 clinical trial [NCT04211337] for selpercatinib, also known as LOXO-292
https://www.lillyoncology.com/
Tue December 31, 2019 1:00 PM|Canada Newswire|About: AMRN, HLTRF
TORONTO, Dec. 31, 2019 /CNW/ - HLS Therapeutics Inc. (HLTRF) ("HLS" or the "Company") (TSX:HLS)
Dec. 31, 2019 1:17 PM ET|About: Amarin Corporation plc (AMRN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3528971-cv-benefit-claim-for-amarins-vascepa-okd-in-canada-shares-up-3
Mon December 30, 2019 1:09 PM|PR Newswire|About: LLY
INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)
12/30/2019Download PDF
INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company
Thu January 2, 2020 8:31 AM|PR Newswire|About: BMRN
PR Newswire
SAN RAFAEL, Calif., Jan. 2, 2020 /PRNewswire/ --BioMarin Pharmaceutical Inc. (BMRN)
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
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
Mon December 23, 2019 3:13 PM|PR Newswire|About: AGN
PR Newswire
DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (AGN)
https://media.allergan.com/products/Ubrelvy_pi.pdf
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
DECEMBER 27, 2019 / 3:02 AM / UPDATED 5 HOURS AGO
BEIJING (Reuters) - China has approved imports of Johnson & Johnson’s Tremfya (guselkumab)
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
Fri December 27, 2019 10:30 PM|GlobeNewswire|About: BGNE
BEIJING, China and CAMBRIDGE, Mass., Dec. 27, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd.,
https://www.beigene.com/science-and-product-portfolio/pipeline
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
Thu December 19, 2019 7:25 PM|PR Newswire
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
Fri December 20, 2019 7:15 AM|Business Wire|About: MRK
https://www.merck.com/index.html
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/
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
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
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/
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
CORPORATE/FINANCIAL NEWSFRIDAY, DECEMBER 20, 2019 6:59 AM EST
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/
December 20, 2019
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)
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)
BEERSE, Belgium 19DEC2019
Dec. 19, 2019 6:35 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor
Wed December 18, 2019 7:49 PM|PR Newswire|About: ALPMY, SGEN
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)
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://www.astellas.com/us/innovation/r-and-d
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
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
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)
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)
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)
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/
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
https://www.businesswire.com/news/home/20191218005517/en/
Wed December 18, 2019 10:50 AM|PR Newswire|About: ABBV
PR Newswire
NORTH CHICAGO, Ill., Dec. 18, 2019 /PRNewswire/ -- AbbVie (ABBV)
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/
Dec. 18, 2019 10:26 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor
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
Wed December 18, 2019 2:56 PM|Canada Newswire|About: ABBV
MONTREAL, Dec. 18, 2019 /CNW/ - AbbVie (ABBV)
http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf
https://www.rituxan.com/patient/what-is-rituxan.html
VENCLEXTA is a prescription medicine used:
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.
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/
Tue December 17, 2019 2:09 PM|Business Wire|About: MRK
Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada,
https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1
https://www.merck.com/clinical-trials/index.html
https://www.merck.com/index.html
https://www.businesswire.com/news/home/20191217005774/en/
Mon December 16, 2019 4:45 PM|PR Newswire|About: MNK
STAINES-UPON-THAMES, United Kingdom, Dec. 16, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK),
https://clinicaltrials.gov/ct2/show/NCT03656692?term=acthar&cond=Uveitis&rank=4
https://www.acthar.com/pdf/Acthar-PI.pdf
Nov. 15, 2019 7:38 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor
Dec. 19, 2019 6:47 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor
Basel, 19 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
Tue December 17, 2019 5:15 PM|Business Wire|About: MRK
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,
https://clinicaltrials.gov/ct2/show/NCT02625961
. https://www.merck.com/clinical-trials/index.html
https://www.businesswire.com/news/home/20191217005846/en/
Dec. 17, 2019 4:53 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Edito
PUBLISHED17 December 2019
Tue December 17, 2019 7:30 AM|Business Wire|About: DRNA
LEXINGTON, Mass.--(BUSINESS WIRE)-- Dicerna™ Pharmaceuticals, Inc. (Nasdaq: DRNA)
https://www.businesswire.com/news/home/20191217005176/en/
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://seekingalpha.com/news/3526343-lilly-to-use-dexcom-cgms-in-automated-insulin-dosing-system
Mon December 16, 2019 8:05 AM|Business Wire|About: ABMD
DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed (NASDAQ: ABMD)
http://www.abiomed.com/impella
Mon December 16, 2019 8:15 AM|PR Newswire|About: BMRN
PR Newswire
SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)
Dec. 16, 2019 11:37 AM ET|About: BioMarin Pharmaceutica... (BMRN)|By: Douglas W. House, SA News Editor
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
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
Mon December 16, 2019 6:36 PM|Canada Newswire|About: GSK
LONDON, Dec. 16, 2019 /CNW/ -- GlaxoSmithKline plc (GSK)
Dec. 17, 2019 7:16 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
Tue December 17, 2019 6:45 AM|Business Wire|About: SGMO
BRISBANE, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (SGMO)
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.businesswire.com/news/home/20191217005318/en/
Fri December 13, 2019 6:14 PM|PR Newswire|About: AMRN
PR Newswire
DUBLIN and BRIDGEWATER, N.J., Dec. 13, 2019 /PRNewswire/ -- Amarin Corporation plc (AMRN)
https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf
Home / All posts / 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/
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
13 December 2019
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
Dec. 13, 2019 6:43 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
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://hkexir.beigene.com/?loc=US
https://www.beigene.com/PDF/BRUKINSAUSPPI.pdf
Mon December 16, 2019 7:00 AM|PR Newswire|About: AGN
PR Newswire
DUBLIN, Dec. 16, 2019 /PRNewswire/ -- Allergan plc (AGN)
https://www.allergan.com/products/botox-cosmetic
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.businesswire.com/news/home/20191216005231/en/
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
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
Mirati Therapeutics (MRTX)
https://www.mirati.com/pipeline/
Dec. 13, 2019 8:25 AM ET|About: BeiGene, Ltd. (BGNE)|By: Mamta Mayani, SA News Editor
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.
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
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://www.boehringer-ingelheim.us/
https://www.lillydiabetes.com/
https://www.lilly.com/products
12/13/2019Download PDF
RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)
Fri December 13, 2019 6:32 AM|GlobeNewswire|About: GMAB
Company Announcement
Copenhagen, Denmark; December 13, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)
Dec. 13, 2019 7:57 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor
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/
TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib) are registered trademarks of Genentech, a member of the Roche Group.
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/
Fri December 13, 2019 6:47 AM|PR Newswire|About: LLY
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/
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)
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.
Dec. 13, 2019 7:17 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor
BEOVU® (brolucizumab-dbll) injection is used for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).
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.businesswire.com/news/home/20191212005841/en/
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
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
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/topics/cancer-immunotherapy
https://www.gene.com/patients/medicines/zelboraf
Thu December 12, 2019 1:05 AM|Business Wire|About: RHHBY
https://www.gene.com/download/pdf/perjeta_prescribing.pdf
https://www.gene.com/download/pdf/herceptin_prescribing.pdf
https://www.businesswire.com/news/home/20191211006028/en/
Thu December 12, 2019 1:00 AM|PR Newswire|About: AMGN, UCBJY
PR Newswire
THOUSAND OAKS, Calif. and BRUSSELS, Dec. 11, 2019 /PRNewswire/ -- Amgen (AMGN) and UCB (Euronext Brussels: UCB)
Thu December 12, 2019 6:45 AM|Business Wire|About: MRK
New Findings from Phase 3 KEYNOTE-042 Study Were Presented Today at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2019
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada
https://www.merck.com/clinical-trials/index.html
https://www.merck.com/index.html
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.businesswire.com/news/home/20191212005312/en/
https://seekingalpha.com/news/3525781-mercks-keytruda-extends-survival-in-first-line-lung-cancer
PUBLISHED12 December 2019
https://seekingalpha.com/news/3525759-astrazenecas-imfinzi-okd-in-china-for-lung-cancer
Thu December 12, 2019 7:00 AM|Canada Newswire
DORVAL, QC, Dec. 12, 2019 /CNW/ - Novartis Pharmaceuticals Canada Inc
https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/#
https://www.us.kymriah.com/acute-lymphoblastic-leukemia-children/
Wed December 11, 2019 4:05 PM|Business Wire|About: GILD
-- Investigational KTE-X19 To Be First Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma if Approved --
-- Filing for Kite’s Second CAR T Therapy Marks Potential Expansion of Company’s Cell Therapy Portfolio --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)
https://www.businesswire.com/news/home/20191211005861/en/
Dec. 11, 2019 4:20 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
Wed December 11, 2019 6:45 AM|PR Newswire|About: LLY
PR Newswire
INDIANAPOLIS, Dec. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)
https://www.lillyoncology.com/
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/
Dec. 11, 2019 9:19 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
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)
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
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
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.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
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/
Tue December 10, 2019 7:30 AM|PR Newswire|About: AMGN
PR Newswire
THOUSAND OAKS, Calif., Dec. 10, 2019 /PRNewswire/ -- Amgen (AMGN)
https://www.darzalex.com/newly-diagnosed-multiple-myeloma#banner-click
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/
Dec. 10, 2019 7:34 AM ET|About: Vertex Pharmaceuticals... (VRTX)|By: Douglas W. House, SA News Editor
- 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
Dec. 10, 2019 8:24 AM ET|About: Roche Holding AG (RHHBY)|By: Mamta Mayani, SA News Editor
Sat December 7, 2019 3:05 AM|GlobeNewswire|About: XBITGlobeNewswire
AUSTIN, Texas, Dec. 07, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT)
https://clinicaltrials.gov/ct2/show/NCT03496974
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
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
Mon December 9, 2019 2:50 PM|PR Newswire|About: NVS
https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/
Mon December 9, 2019 4:30 PM|Business Wire|About: BLUE
https://www.bluebirdbio.com/our-science/pipeline
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
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/
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
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.seattlegenetics.com/
https://www.businesswire.com/news/home/20191209005142/en/
Mon December 9, 2019 9:00 AM|PR Newswire|About: AMGN
PR Newswire
THOUSAND OAKS, Calif., Dec. 9, 2019 /PRNewswire/ -- Amgen (AMGN) today announced the signing of a lease with BioMed Realty (BMR)
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.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf
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/
Mon December 9, 2019 7:30 AM|Business Wire|About: SESN
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (SESN),
https://sesenbio.com/our-programs/#bladder-cancer
https://www.businesswire.com/news/home/20191209005207/en/
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
Sun December 8, 2019 9:00 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y., Dec. 8, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)
Sun December 8, 2019 8:00 AM|PR Newswire|About: JNJPR Newswire
NEW BRUNSWICK, N.J., Dec. 8, 2019 /PRNewswire/ -- Johnson & Johnson (JNJ)
https://www.who.int/ihr/procedures/statement-emergency-committee-ebola-drc-july-2019.pdf
Sun December 8, 2019 7:30 AM|Business Wire|About: RHHBY
https://www.gene.com/topics/hematology
https://www.businesswire.com/news/home/20191208005034/en/
https://www.gene.com/media/press-releases/14829/2019-12-08/new-data-demonstrate-the-continued-clini
Sun December 8, 2019 7:30 AM|PR Newswire|About: ABBV
https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html
Sun December 8, 2019 4:30 PM|Business Wire|About: BMY
Heavily pre-treated patients with chronic lymphocytic leukemia receiving liso-cel achieved durable complete responses, including undetectable minimal residual disease
Preliminary data from the PILOT study showed promising efficacy and safety as second-line therapy in patients with aggressive relapsed or refractory large B-cell non-Hodgkin lymphoma who were transplant ineligible
Separate analysis of patients treated in the outpatient setting across three studies also presented
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (BMY) (NYSE: BMY)
https://www.businesswire.com/news/home/20191208005049/en/
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/
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/
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)
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.
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
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
http://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/testing.html
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.businesswire.com/news/home/20191207005029/en/
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/
Sat December 7, 2019 2:00 PM|Business Wire|About: BLUE
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (BLUE)
https://www.businesswire.com/news/home/20191207005044/en/
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/
Sat December 7, 2019 7:33 AM|PR Newswire|About: ABBV
PR Newswire
NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)