Wed December 4, 2019 4:30 PM|Business Wire|About: SESN
Company gained FDA alignment on the final content of the BLA
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (SESN)
https://www.businesswire.com/news/home/20191204005921/en/
Thu December 5, 2019 7:00 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y., Dec. 5, 2019 /PRNewswire/ --
Results from initial 6-patient cohort show pozelimab reduced lactate dehydrogenase (LDH) to normal levels at week 8 in patients with paroxysmal nocturnal hemoglobinuria (PNH), utilizing a weekly subcutaneous dosing regimen
Second part of Phase 2 trial initiated; plans for Phase 3 program underway
Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)
https://www.regeneron.com/pipeline
https://seekingalpha.com/news/3523950-regenerons-pozelimab-shows-positive-effect-in-pnh-study
Thu December 5, 2019 6:45 AM|Business Wire|About: MRK
AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Versus Placebo in BRCAm Advanced Ovarian Cancer Following Response to Platinum-Based Chemotherapy
Only PARP Inhibitor Approved in This Setting in China
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.businesswire.com/news/home/20191205005115/en/
http://elearning.wfh.org/resource/general-care-and-management-of-hemophilia/
Thu December 5, 2019 3:00 AM|PR Newswire|About: TAK
NIJMEGEN, Netherlands, Dec. 5, 2019 /PRNewswire/ -- Enzyre
Thu December 5, 2019 7:00 AM|PR Newswire
WHIPPANY, N.J., Dec. 5, 2019 /PRNewswire/
https://media.bayer.com/baynews/baynews.nsf/id/news-overview-category-search-en#/search
Dec. 5, 2019 11:41 AM ET|About: Biogen Inc. (BIIB)|By: Douglas W. House, SA News Editor
https://clinicaltrials.gov/ct2/show/NCT02484547?intr=BIIB-037&lead=biogen&phase=2&draw=2&rank=2
https://clinicaltrials.gov/ct2/show/NCT02477800?intr=BIIB-037&lead=biogen&phase=2&draw=2&rank=1
https://seekingalpha.com/symbol/BIIB
http://investors.biogen.com/static-files/ddd45672-9c7e-4c99-8a06-3b557697c06f
Tue December 3, 2019 6:30 PM|Business Wire|About: RHHBY
– Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.genentech-access.com/hcp.html
https://www.businesswire.com/news/home/20191203006105/en/
https://www.gene.com/topics/cancer-immunotherapy
https://seekingalpha.com/news/3523561-fda-oks-roches-tecentriq-for-first-line-lung-cancer
Tue December 3, 2019 5:39 PM|PR Newswire|About: JNJPR Newswire
NEW BRUNSWICK, N.J., Dec. 3, 2019 /PRNewswire/ -- Johnson & Johnson Consumer Inc. (NYSE: JNJ)
https://www.factsabouttalc.com/
Tue December 3, 2019 7:38 AM|Business Wire|About: BMY, XLRN
PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and Acceleron Pharma Inc. (XLRN)
https://media.celgene.com/content/uploads/reblozyl-pi.pdf
http://acceleronpharma.com/science-pipeline/pipeline/
https://www.businesswire.com/news/home/20191203005566/en/
https://seekingalpha.com/news/3523331-fda-ad-com-set-for-bristol-myers-luspatercept-for-mds
Wed December 4, 2019 6:59 AM|Business Wire|About: BMY
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY)
http://packageinserts.bms.com/pi/pi_orencia.pdf
https://www.businesswire.com/news/home/20191204005265/en/
Wed December 4, 2019 7:00 AM|Business Wire|About: AVEO
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AVEO Oncology (NASDAQ: AVEO)
https://www.businesswire.com/news/home/20191204005441/en/
https://www.aveooncology.com/product-candidates/tivozanib/
Wed December 4, 2019 5:26 PM|PR Newswire|About: AGN
PR Newswire
DUBLIN, Dec. 4, 2019 /PRNewswire/ -- Allergan plc (AGN)
https://www.allergan.com/research-and-development/pipeline
Mon December 2, 2019 4:00 PM|PR Newswire|About: AMGN
PR Newswire
THOUSAND OAKS, Calif., Dec. 2, 2019 /PRNewswire/ -- Amgen (AMGN)
https://www.amgen.com/media/news-releases/2019/12/amgen-announces-data-being-presented-at-ash-2019/
Tue December 3, 2019 7:30 AM|GlobeNewswire|About: BIIB
CAMBRIDGE, Mass., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (BIIB) (Nasdaq: BIIB)
https://www.biogen.com/en_us/pipeline.html
Tue December 3, 2019 7:30 AM|PR Newswire|About: HRTX
SAN DIEGO, Dec. 3, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (HRTX)
Dec. 3, 2019 7:45 AM ET|About: Heron Therapeutics, Inc. (HRTX)|By: Mamta Mayani, SA News Edito
Tue December 3, 2019 8:15 AM|PR Newswire|About: VAR
PALO ALTO, Calif., Dec. 3, 2019 /PRNewswire/
Tue December 3, 2019 9:00 AM|PR Newswire|About: JNJ
PR Newswire
SANTA ANA, Calif., Dec. 3, 2019 /PRNewswire/ -- Johnson & Johnson Vision*
Tue December 3, 2019 8:00 AM|GlobeNewswire|About: IMMU
MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Immunomedics,
https://www.immunomedics.com/our-science/pipeline/
Tue November 26, 2019 6:40 PM|GlobeNewswire|About: ISRG
Intuitive’s new sealing instrument and its first generator add versatility1
SUNNYVALE, Calif., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Intuitive (ISRG)
https://www.intuitive.com/en-us/products-and-services/da-vinci/systems
Thu November 28, 2019 9:00 PM|Business Wire|About: CHGCY, RHHBY
TOKYO--(BUSINESS WIRE)-- Chugai Pharmaceutical Co., Ltd. (CHGCF) (TOKYO:4519)
https://www.chugai-pharm.co.jp/english/
https://www.nejm.org/doi/full/10.1056/NEJMoa1901747
https://www.businesswire.com/news/home/20191128005586/en/
PUBLISHED29 November 2019
AstraZeneca
Nov. 29, 2019 7:49 AM ET|About: AstraZeneca PLC (AZN)|By: Clark Schultz, SA News Editor
https://seekingalpha.com/news/3522640-astrazeneca-lands-fast-review-imfinzi
HEALTH NEWSNOVEMBER 29, 2019 / 2:26 AM / UPDATED 6 HOURS AGO
2 MIN RE
Mon December 2, 2019 6:45 AM|Business Wire|About: MRK
Application Based on Results from Phase 2 KEYNOTE-057 Trial, to be Discussed at December FDA Oncologic Drugs Advisory Committee (ODAC) Meeting
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/20191202005300/en/
Mon December 2, 2019 6:00 AM|GlobeNewswire|About: AMRN
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN),
Dec. 2, 2019 6:24 AM ET|About: Amarin Corporation plc (AMRN)|By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3522821-ema-accepts-amarins-marketing-application-icosapent-ethyl
Mon December 2, 2019 8:00 AM|Business Wire|About: ALPMY, SGEN
- Companies to Initiate Phase 3 Trial to Support Global Registrations -
BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. (ALPMF) (TSE: 4503,
https://www.businesswire.com/news/home/20191202005357/en/
https://www.cancer.net/cancer-types/bladder-cancer/introduction
Tue November 26, 2019 6:45 AM|Business Wire|About: MRK
Third Approval for KEYTRUDA in First-Line NSCLC in China in Less Than One Year
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,
https://www.businesswire.com/news/home/20191126005394/en/
Tue November 26, 2019 6:45 AM|PR Newswire|About: MNK
PR Newswire
STAINES-UPON-THAMES, United Kingdom, Nov. 26, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK
http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26326
https://clinicaltrials.gov/ct2/show/NCT03320070
https://www.acthar.com/pdf/Acthar-PI.pdf
http://www.mallinckrodt.com/products/brands/
Tue November 26, 2019 8:00 AM|Business Wire|About: A
https://www.businesswire.com/news/home/20191126005181/en/
Tue November 26, 2019 2:46 AM|GlobeNewswire|About: GNFT
GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH
Lille (France), Cambridge (Massachusetts, United States), November 26, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT)
https://www.genfit.com/pipeline/elafibranor/
https://ml-eu.globenewswire.com/Resource/Download/12e07f8b-6afb-4b50-b4ec-3bce9cc11397
Wed November 27, 2019 2:00 AM|Business Wire|About: QGEN
Enabling highly automated screening solution for latent tuberculosis in all throughput segments
Germantown, Md. & HILDEN, Germany & SALUGGIA, Italy--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and DiaSorin (DSRLF) (FTSE MIB: DIA)
https://www.businesswire.com/news/home/20191126005848/en/
Wed November 27, 2019 7:30 AM|Business Wire|About: INCY
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)
https://clinicaltrials.gov/ct2/show/NCT02924376
https://www.businesswire.com/news/home/20191127005145/en/
Sat November 23, 2019 10:30 AM|Business Wire|About: TAK
− Data presented from the pivotal Phase 3 trial include an update on overall efficacy of the vaccine candidate, as well as formal analyses of secondary efficacy endpoints by serotype, baseline serostatus and disease severity −
− 18-month results build upon the efficacy and safety data reported in the 12-month analysis; overall vaccine efficacy remained generally consistent and the trial met all secondary endpoints for which there were a sufficient number of cases; safety and efficacy will be assessed over a total of four and a half years –
− Takeda (TKPHF) presented 11 abstracts across its vaccine pipeline at ASTMH, including oral presentations on its dengue and Zika vaccine candidates −
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502 / NYSE:TAK)
https://clinicaltrials.gov/ct2/show/record/NCT02747927?term=den-301&rank=1&view=record
https://www.takedavaccines.com/
https://www.businesswire.com/news/home/20191123005045/en/
Mon November 18, 2019 6:00 AM|Business Wire|About: KRTX
KarXT Demonstrated Statistically Significant and Clinically Meaningful Improvement in Total PANSS Score at All Time Points Over Five Weeks and was Well-Tolerated Compared to Placebo
Improvement in Total PANSS Score at Five Weeks was 11.6 Points Compared to Placebo (p<0.0001)
No Evidence of Somnolence, Extrapyramidal Side Effects or Weight Gain Relative to Placebo
Data Support Advancing KarXT to Phase 3 and Continued Development in Other CNS Disorders
Conference Call and Webcast to Take Place Today at 8:30 a.m. EST
BOSTON--(BUSINESS WIRE)-- Karuna Therapeutics, Inc. (KRTX),
https://clinicaltrials.gov/ct2/show/NCT03697252?lead=karuna&phase=1&draw=2&rank=1
https://seekingalpha.com/news/3520035-karuna-86-percent-premarket-positive-karxt-data
https://www.businesswire.com/news/home/20191118005243/en/
Novartis Chief Executive Vas Narasimhan has been steering the Swiss drugmaker toward newer technologies through deals. PHOTO: ARND WIEGMANN/REUTERS
By Dana Cimilluca, Cara Lombardo and Jonathan D. RockoffUpdated Nov. 23, 2019 10:06 pm ET
Novartis AG NVS -0.06% is nearing a deal to buy cholesterol-drug maker The Medicines Co. for nearly $7 billion, in an expensive bid to expand its reach in the lucrative market for heart treatments.
https://seekingalpha.com/news/3521670-novartis-nears-7b-deal-medicines-co
Mon November 25, 2019 1:00 AM|Business Wire|About: RHHBY
– Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20191124005113/en/
Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.
https://www.gene.com/medical-professionals/pipeline
Mon November 25, 2019 8:00 AM|Business Wire|About: SGEN
- Approval of Supplemental New Drug Submission for ADCETRIS in Combination with CHP Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma based on Positive Phase 3 ECHELON-2 Clinical Trial Results -
BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)
https://www.businesswire.com/news/home/20191125005237/en/
https://www.adcetris.com/#page-isi
https://www.seattlegenetics.com/pipeline/brentuximab-vedotin
https://www.seattlegenetics.com/
Mon November 25, 2019 7:00 PM|PR Newswire|About: ALPMY, PFEPR Newswire
TOKYO, Nov. 25, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503,
https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf
https://www.astellas.com/en/news/15446
Fri November 22, 2019 7:30 AM|GlobeNewswire|About: BIIB
CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB)
https://seekingalpha.com/news/3521496-biogens-ms-drug-shows-improved-gi-tolerability-vs-tecfidera
https://www.vumerity.com/en_us/home.html
November 22, 2019 at 7:30 AM EST
CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)
Fri November 22, 2019 8:30 AM|Business Wire|About: ALXN
- SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Japan -
- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -
BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN)
https://www.businesswire.com/news/home/20191122005192/en/
https://seekingalpha.com/news/3521518-alexion-pharmaceuticals-gains-approval-soliris-japan
Friday, November 22, 2019 8:30 am EST
- SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Japan -
- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -
BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)
Fri November 22, 2019 8:43 AM|Business Wire|About: A
PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab) in Europe
SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A)
https://www.businesswire.com/news/home/20191122005275/en/
https://www.agilent.com/about/newsroom/presrel/2019/22nov-ca19033.html
https://www.agilent.com/search/?N=900010356&Ntt=PD+L1+IHC+22C3+pharmDx
Fri November 22, 2019 11:05 AM|Business Wire|About: RHHBY
– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib –
– Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20191122005376/en/
Fri November 22, 2019 10:00 PM|Business Wire|About: TAK
– ALUNBRIG Reduced the Risk of Disease Progression or Death by 76% in Patients whose Disease Had Spread to the Brain, and by 57% in All Patients, when Compared to Crizotinib –
– Median Progression-Free Survival with ALUNBRIG was Three Times Longer than that with Crizotinib –
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)
Nov. 22, 2019 2:10 PM ET | About: Regeneron Pharmaceuticals, Inc. (REGN)
https://www.businesswire.com/news/home/20191122005494/en/
Sat November 23, 2019 5:00 AM|GlobeNewswire|About: BGNE
CAMBRIDGE, Mass. and BEIJING, China, Nov. 23, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)
https://www.globenewswire.com/NewsRoom/AttachmentNg/afe76614-5866-42d4-9623-adfe526c7ec6
https://www.beigene.com/science-and-product-portfolio/pipeline?loc=US
https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab
Thu November 21, 2019 4:04 PM|PR Newswire|About: BMRN
PR Newswire
SAN RAFAEL, Calif., Nov. 21, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)
https://www.biomarin.com/products/pipeline
PUBLISHED21 November 2019
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programmes.
Nov. 21, 2019 2:13 PM ET|About: AstraZeneca PLC (AZN)|By: Carl Surran, SA News Editor
https://seekingalpha.com/news/3521306-fda-oks-astrazenecas-calquence-lymphocytic-leukemia
Thu November 21, 2019 9:02 AM|PR Newswire|About: JNJPR Newswire
NEW YORK, Nov. 21, 2019 /PRNewswire/ -- The Johnson & Johnson Medical Devices Companies*
Thu November 21, 2019 11:05 AM|GlobeNewswire|About: MDT
Clinical Data Demonstrates IN.PACT™ AV DCB Is Safe, Reduces Reinterventions, and Maintains Access for End-Stage Renal Disease Patients Undergoing Dialysis
DUBLIN, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)
Paclitaxel Coated Balloon
Nov. 21, 2019 11:13 AM ET|About: Medtronic plc (MDT)|By: Clark Schultz, SA News Editor
https://seekingalpha.com/news/3521268-medtronic-lands-fda-approval-renal-disease-treatment
Thu November 21, 2019 8:30 AM|PR Newswire|About: ABBV
PR Newswire
NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (ABBV)
Thu November 21, 2019 6:21 AM|PR Newswire|About: AMGN, BMY, CELGPR Newswire
THOUSAND OAKS, Calif., Nov. 21, 2019 /PRNewswire/ -- Amgen (AMGN) today announced the successful completion of its acquisition of worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for moderate-to-severe plaque psoriasis and psoriatic arthritis. Otezla was acquired from Celgene Corporation (CELG) in connection with its previously announced merger with Bristol-Myers Squibb Company (BMY), which was completed on Nov. 20.
Differentiated Therapy Strengthens Amgen's Long-Standing Expertise in Inflammation
THOUSAND OAKS, Calif., Nov. 21, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
https://www.amgen.com/media/news-releases/2019/11/amgen-completes-acquisition-of-otezla-apremilast/
Wed November 20, 2019 6:45 AM|Business Wire|About: MRK
KEYTRUDA is the First Anti-PD-1 Therapy Approved in Europe for the First-Line Treatment of Head and Neck Cancer as Monotherapy or in Combination with Chemotherapy, in Patients Whose Tumors Express PD-L1 (CPS ≥1)
Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 Trial
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.businesswire.com/news/home/20191120005267/en/
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.merck.com/research/index.html#IntroVideo
Oct. 18, 2019 7:19 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3506829-european-advisory-group-backs-new-regimens-mercks-keytruda
Wed November 20, 2019 2:00 AM|PR Newswire|About: MKKGY
https://www.emdgroup.com/en/research.html
SOURCE Merck KGaA (MKGAY)
Wed November 20, 2019 7:30 AM|Business Wire|About: NVCR
Presentations on Tumor Treating Fields cover a broad and growing range of topics, with nearly 80 percent of presentations prepared by external authors
ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NVCR)
Wed November 20, 2019 6:58 AM|Business Wire|About: BMY
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)
. https://www.businesswire.com/news/home/20191120005427/en/
https://packageinserts.bms.com/pi/pi_opdivo.pdf
https://packageinserts.bms.com/pi/pi_yervoy.pdf
November 20, 2019
Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood).
https://www.ncbi.nlm.nih.gov/books/NBK537178/
Nov. 20, 2019 12:36 PM ET|About: Alnylam Pharmaceutical... (ALNY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3520900-fda-oks-alnylams-givosiran-ahp
Sat November 16, 2019 9:15 AM|PR Newswire
PR Newswire
TITUSVILLE, N.J., Nov. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson
https://www.janssen.com/cardiovascular-and-metabolism
https://www.invokana.com/splash-home
https://seekingalpha.com/news/3520157-j-and-j-launches-innovative-study-expanded-use-invokana
https://www.abstractsonline.com/pp8/#!/7891/presentation/35097
Mon November 18, 2019 5:30 PM|GlobeNewswire|About: AMRN
REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction in all-cause mortality
New analysis determined icosapent ethyl (Vascepa®) is highly cost-effective in patients from the REDUCE-IT study and, as is rarely found, may result in net healthcare cost-savings to patients, payers and society
Data showed prevalence of elevated risk of major cardiovascular events (mean 10-year ASCVD risk score greater than 20%) in more than 20% of patients on statins with triglycerides below 150 mg/dL
Interim EVAPORATE study provides important mechanistic data with relevance to the reduction in cardiovascular events seen in the REDUCE-IT clinical trial; final study results likely in early 2020
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)
https://www.abstractsonline.com/pp8/#!/7891/presentation/40313
https://www.abstractsonline.com/pp8/#!/7891/presentation/33779
https://www.abstractsonline.com/pp8/#!/7891/presentation/35090
https://amarincorp.com/products.html
https://investor.amarincorp.com/static-files/c2473067-dcab-47ea-9968-b908da51c671
November 19, 2019 05:00 AM Eastern Standard Time
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd.
https://www.businesswire.com/news/home/20191119005429/en/
If approved, Merck (NYSE:MRK) will commercialize.
https://seekingalpha.com/news/3520355-fda-accepts-bioepis-application-avastin-biosimilar
Tue November 19, 2019 7:00 AM|PR Newswire|About: ALKS
DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)
Nov. 20, 2019 5:13 AM ET | About: Alkermes plc (ALKS)
https://seekingalpha.com/article/4307949-alkermes-plc-alks-investor-presentation-sliideshow
Tue November 19, 2019 11:14 AM|GlobeNewswire|About: GMAB
Company Announcement
Copenhagen, Denmark; November 19, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)
http://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
European Commission approves the use of Johnson & Johnson (JNJ -0.2%) unit Janssen Biotech's Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone
https://seekingalpha.com/news/3520513-expanded-use-j-and-js-darzalex-okd-europe
.
Tue November 19, 2019 11:22 AM|PR Newswire|About: AGN
PR Newswire
DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Allergan plc (AGN)
Mon November 18, 2019 1:00 AM|Business Wire|About: RHHBY
— Study results reflect advancements in HER2-positive, triple-negative, and hormone receptor-positive breast cancer —
— Follow-up data from pivotal Phase III APHINITY study evaluating Perjeta plus Herceptin and chemotherapy in HER2-positive early breast cancer —
— Results from Phase III FeDeriCa study confirming the non-inferiority of a fixed-dose combination of Perjeta and Herceptin administered under the skin —
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: 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/20191117005086/en/
Mon November 18, 2019 6:00 AM|GlobeNewswire|About: CYDY
Independent data from the PRESTIGIO Registry Study Group in Italy shows leronlimab inhibits multi-drug resistant HIV-1 viruses in Heavily Treatment-Experienced (HTE) patients
VANCOUVER, Washington, Nov. 18, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)
https://seekingalpha.com/symbol/CYDY
Mon November 18, 2019 7:00 AM|Canada Newswire|About: MRK
KIRKLAND, QC, Nov. 18, 2019 /CNW/ - Merck Canada Inc., an affiliate of Merck & Co., Inc.,
https://www.merck.ca/static/pdf/PIFELTRO-PM_E.pdf
DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not taken HIV-1 medicines before. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
Mon November 18, 2019 6:45 AM|Business Wire|About: PFE
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)
http://labeling.pfizer.com/ShowLabeling.aspx?id=12780
https://www.businesswire.com/news/home/20191118005208/en/
Mon November 18, 2019 9:00 AM|PR Newswire|About: AMGN, CYTK
THOUSAND OAKS, Calif., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Nov. 18, 2019 /PRNewswire/ -- Amgen (AMGN), Cytokinetics, Incorporated (CYTK)
Mon November 18, 2019 6:30 AM|Business Wire|About: MRK
Vericiguat Reduced the Risk of Heart Failure Hospitalization or Cardiovascular Death in Patients with Worsening Chronic Heart Failure with Reduced Ejection Fraction, Compared to Placebo When Added to Available Heart Failure Therapies
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada
https://www.ncbi.nlm.nih.gov/pubmed/24092345
https://www.businesswire.com/news/home/20191118005267/en/
Fri November 15, 2019 7:30 AM|Business Wire|About: CELG
REVLIMID® and rituximab (R2) has the potential to become a chemotherapy-free combination treatment option for patients with follicular lymphoma who have relapsed or did not respond to previous treatment
The positive opinion was based on the results of the Phase 3 AUGMENT study, which showed the R2 regimen conferred a statistically significantly improvement in progression-free survival versus rituximab monotherapy
SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (CELG)
http://media.celgene.com/content/uploads/revlimid-pi.pdf
https://www.celgene.com/research-development/pipeline-pdf/
https://www.businesswire.com/news/home/20191115005209/en/
FDA NEWS RELEASE
November 15, 2019
https://seekingalpha.com/news/3519890-fda-oks-novartis-crizanlizumab-sickle-cell-disease
Sat November 16, 2019 9:00 AM|PR Newswire|About: AMGNPR Newswire
THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen (AMGN)
Additional FOURIER Analysis Shows Lowering LDL-C With Repatha Did Not Impair Patient-Reported Cognition
THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen
Sun November 17, 2019 10:45 AM|Business Wire|About: AZN
Data were consistent in patients with and without type 2 diabetes, showed early effects in the first month and improvement in patient-reported outcomes
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca
https://www.azpicentral.com/farxiga/farxiga.pdf#page=1
https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg
https://www.businesswire.com/news/home/20191117005052/en/
Sun November 17, 2019 10:50 AM|PR Newswire|About: LLY
PR Newswire
RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 17, 2019 /PRNewswire/
https://www.boehringer-ingelheim.us/innovation/pipeline
https://www.lillydiabetes.com/
Sun November 17, 2019 11:47 AM|Business Wire|About: AZN
Secondary endpoint of subgroup analysis showed similar rates of the composite of all-cause death, myocardial infarction or stroke between monotherapy and DAPT
Results of subgroup analysis of TWILIGHT randomized clinical trial presented at AHA Scientific Sessions 2019
WILMINGTON, Del.--(BUSINESS WIRE)
https://www.azpicentral.com/brilinta/brilinta.pdf#page=1
https://www.nejm.org/doi/full/10.1056/NEJMoa1908419?query=featured_home
https://www.businesswire.com/news/home/20191117005054/en/
Wed November 13, 2019 5:07 PM|PR Newswire|About: LLY
RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2019 /PRNewswire/
https://www.lillydiabetes.com/
Thu November 14, 2019 8:27 AM|PR Newswire|About: BMRN
PR Newswire
SAN RAFAEL, Calif., Nov. 14, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)
Thu November 14, 2019 6:55 AM|Business Wire|About: MRK
AstraZeneca and Merck’s Selumetinib Would Become the First Medicine Indicated for the Treatment of Certain Pediatric Patients with NF1 Plexiform Neurofibromas if Approved
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada
https://www.businesswire.com/news/home/20191114005242/en/
https://www.merck.com/clinical-trials/index.html
https://ghr.nlm.nih.gov/condition/neurofibromatosis-type-1
Nov. 14, 2019 4:09 PM ET|About: Amarin Corporation plc (AMRN)|By: Douglas W. House, SA News Editor
Thu November 14, 2019 5:34 PM|GlobeNewswire|About: AMRN
Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial November 14, 2019 Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN)
https://investor.amarincorp.com/node/18376/pdf
https://www.youtube.com/watch?v=VloIzGYw6vo
by Kyle Blankenship | Nov 17, 2019 5:32pm
Thu November 14, 2019 4:20 PM|GlobeNewswire|About: BGNE
84% of patients taking BRUKINSA achieved an overall response1
- BRUKINSA is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells and the only BTK inhibitor with the flexibility to be taken once or twice daily
CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd.
https://www.beigene.com/PDF/BRUKINSAUSPI.pdf
https://ml.globenewswire.com/Resource/Download/c47ea153-ba25-4dd1-8155-937b64fdf4b7
https://ml.globenewswire.com/Resource/Download/aca04555-626d-4c35-821b-957abaab640c
PUBLISHED15 November 2019
About Qtrilmet
Qtrilmet is a once-daily oral medicine comprised of the selective sodium‑glucose co-transporter 2 (SGLT2) inhibitor Forxiga, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor Onglyza and metformin hydrochloride extended release indicated as treatment in adults with T2D.
Tue November 12, 2019 11:15 AM|PR Newswire|About: ABBV
PR Newswire
NORTH CHICAGO, Ill., Nov. 12, 2019 /PRNewswire/ -- AbbVie (ABBV)
www.clinicaltrials.gov (NCT03178487).
https://www.rxabbvie.com/pdf/rinvoq_pi.pdf
https://www.abbvie.com/our-science/pipeline.html
Tue November 12, 2019 10:51 AM|Business Wire|About: VRTX
-Eligible patients in Northern Ireland will soon have access to ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor), expanded access to KALYDECO® (ivacaftor) under same terms as NHS England agreement-
LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)
https://www.businesswire.com/news/home/20191112005777/en/
Tue November 12, 2019 8:30 AM|PR Newswire|About: LLYPR Newswire
RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 12, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (LLY)
https://www.lillydiabetes.com/
Tue November 12, 2019 4:01 PM|PR Newswire|About: NBIX
PR Newswire
SAN DIEGO, Nov. 12, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)
https://www.neurocrine.com/pipeline/pipeline-overview/
Wed November 13, 2019 4:00 AM|Business Wire|About: CLVS
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS)
https://www.clovisoncology.com/
https://www.clovisoncology.com/pipeline/pipeline-overview/
https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf
https://www.businesswire.com/news/home/20191113005122/en/
13 November 2019
Positive data from a pivotal study supports new regulatory filing in HES
Issued: London, UK
GlaxoSmithKline plc (GSK)
Nov. 13, 2019 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3518541-glaxos-nucala-successful-pivotal-hes-study
Mon November 11, 2019 1:00 AM|Business Wire|About: RHHBY
– Study demonstrated statistically significant improvements in the overall study population with Type 2 or 3 SMA –
– No treatment related safety findings leading to withdrawal seen in any risdiplam trial to date –
– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20191110005058/en/
https://clinicaltrials.gov/ct2/show/NCT02908685?titles=sunfish&lead=roche&draw=2&rank=1
Basel, Switzerland, South Plainfield, NJ, USA and New York, NY, USA, 29 November 2011
Basel, Switzerland, South Plainfield, NJ, USA and New York, NY, USA – November 29, 2011
Collaboration offers new hope for a potential treatment for the leading genetic cause of death in infants and toddlers
Roche (SIX: RO, ROG; OTCQX: RHHBY), PTC Therapeutics, Inc. (PTC) and the SMA Foundation
https://www.roche.com/media/releases/med-cor-2011-11-29t.htm
Sun November 10, 2019 8:00 AM|GlobeNewswire|About: GNFT
GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019
Lille (France), Cambridge (Massachusetts, United States), November 10, 2019 – GENFIT (Nasdaq and Euronext: GNFT)
(Reuters)
HEALTH NEWSNOVEMBER 11, 2019 / 12:48 PM / UPDATED 2 HOURS AGO
Nov. 11, 2019 1:59 PM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor
Mon November 11, 2019 3:00 PM|Business Wire|About: MRK
Authorization Represents Significant Advancement in the Global Response to Ebola
Merck Remains Committed to Working with International Health Partners in Ebola Outbreak Response
Monday, November 11, 2019 3:00 pm EST
Tue November 12, 2019 6:45 AM|Business Wire|About: PFE
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)
http://labeling.pfizer.com/ShowLabeling.aspx?id=959
Tue November 12, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire
INDIANAPOLIS, Nov. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)
http://uspl.lilly.com/taltz/taltz.html#pi
https://www.arthritis.org/about-arthritis/types/spondyloarthritis/
Tue November 12, 2019 7:00 AM|PR Newswire|About: ALKS, BIIB
DUBLIN, Nov. 12, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)
Mon November 11, 2019 6:59 AM|Business Wire|About: BMY
The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)
https://www.businesswire.com/news/home/20191111005122/en/
https://packageinserts.bms.com/pi/pi_opdivo.pdf
https://packageinserts.bms.com/pi/pi_yervoy.pdf
Sun November 10, 2019 7:01 PM|GlobeNewswire|About: GWPH
Mon November 11, 2019 6:30 AM|GlobeNewswire|About: AMRN
Prespecified Analysis of 3,146 Patients in the USA Enrolled in REDUCE-IT Showed 31% Relative Risk Reductions for First Occurrence of Both 5-Point MACE and 3-Point MACE
Significant Reductions Shown in All Predefined Composite and Individual Cardiovascular Endpoints, Including Cardiovascular Death and All-Cause Mortality
Tolerability and Safety Findings Consistent with Full Study
Results Published Today in Circulation and Scheduled for Presentation at American Heart Association 2019 Scientific Sessions on November 17
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.044440
Mon November 11, 2019 7:30 AM|PR Newswire|About: AGN
PR Newswire
DUBLIN, Nov. 11, 2019 /PRNewswire/ -- Allergan plc (AGN)
Mon November 11, 2019 7:05 AM|GlobeNewswire|About: MYGN
GlobeNewswire
SALT LAKE CITY, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN)
https://obgyn.onlinelibrary.wiley.com/journal/14690705
Mon November 11, 2019 9:00 AM|GlobeNewswire|About: MDT
Data Published in JACC: Clinical Electrophysiology and to be Presented at American Heart Association Scientific Sessions Demonstrates the Potential of Investigational Algorithms in Medtronic Micra Pacemaker to Improve Synchrony and Cardiac Function in AV Block Patients
DUBLIN, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)