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