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Seeking Biotech Alpha DECEMBER 2019 Insight

Vicinium®

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Sesen Bio Completes Successful CMC Type B pre-BLA Meeting with FDA

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://sesenbio.com/ 


 https://ir.sesenbio.com/news-releases/news-release-details/sesen-bio-completes-successful-cmc-type-b-pre-bla-meeting-fda 


 https://www.businesswire.com/news/home/20191204005921/en/ 


Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

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Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder

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.prnewswire.com/news-releases/regeneron-announces-positive-topline-phase-2-data-with-anti-c5-antibody-pozelimab-in-patients-with-a-rare-blood-disorder-300969698.html 


 https://www.regeneron.com/ 


 https://www.regeneron.com/pipeline 


 https://seekingalpha.com/news/3523950-regenerons-pozelimab-shows-positive-effect-in-pnh-study 


LYNPARZA® (olaparib)

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LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

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/ 


 https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-approved-china-first-line-maintenance-therapy-brca-mutated-b 


 https://seekingalpha.com/news/3523919-astrazenecas-lynparza-okd-in-china-for-1st-line-maintenance-of-ovarian-cancer 

ambulant diagnostic technology for coagulation testing

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 http://elearning.wfh.org/resource/general-care-and-management-of-hemophilia/  

Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

Thu December 5, 2019 3:00 AM|PR Newswire|About: TAK

NIJMEGEN, Netherlands, Dec. 5, 2019 /PRNewswire/ -- Enzyre


 https://www.prnewswire.com/news-releases/takeda-and-enzyre-to-develop-diagnostic-device-allowing-hemophilia-patients-to-determine-their-coagulation-status-at-home-300969334.html 


 http://www.enzyre.com/ 


Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

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Seeking Biotech Alpha DECEMBER 2019 Insight

Tecentriq Plus Chemotherapy (Abraxane and Carboplatin)

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FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

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://www.tecentriq.com/ 


 https://www.abraxanepro.com/ 


 https://seekingalpha.com/news/3523561-fda-oks-roches-tecentriq-for-first-line-lung-cancer 

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

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Company Investigation Confirms No Asbestos in Johnson's Baby Powder

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/ 


 https://www.johnsonsbaby.com/ 


 https://www.jnj.com/ 


 https://www.prnewswire.com/news-releases/company-investigation-confirms-no-asbestos-in-johnsons-baby-powder-300968701.html 

Reblozyl® (luspatercept-aamt)

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Bristol-Myers Squibb and Acceleron Pharma Announce FDA Advisory Committee Will Review Reblozyl® (luspatercept-aamt) for Use in Patients With Myelodysplastic Syndromes

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 

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-and-acceleron-pharma-announce-fda-advisor 

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 

http://acceleronpharma.com/ 


ORENCIA® (abatacept)

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Bristol-Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for ORENCIA® (abatacept) to Help Prevent Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

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/ 


 https://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-us-fda-breakthrough-therapy-designation-orencia 


 https://www.bms.com/ 


 https://seekingalpha.com/news/3523581-bristol-myers-orencia-nabs-accelerated-review-status-for-preventing-gvhd 

ubrogepant 50 mg and 100 mg

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Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine

Wed December 4, 2019 5:26 PM|PR Newswire|About: AGN

-- Compared to placebo, ubrogepant 50 mg and 100 mg doses led to significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, a new, more stringent FDA standard in the acute treatment of migraine --

-- Ubrogepant 50 mg and 100 mg also met the secondary efficacy endpoint demonstrating clinically significant pain relief at two hours in the majority of patients studied versus placebo, a primary endpoint used in the studies of older migraine treatments, such as triptans --

-- FDA action on New Drug Application (NDA) expected in December 2019 for ubrogepant, which would make it the first oral CGRP blocker (gepant) to address unmet patient needs in acute treatment of migraine --

PR Newswire

DUBLIN, Dec. 4, 2019 /PRNewswire/ -- Allergan plc (AGN)


 https://www.allergan.com/research-and-development/pipeline 


 https://www.prnewswire.com/news-releases/allergan-announces-positive-phase-3-achieve-i-trial-results-for-ubrogepant-published-in-the-new-england-journal-of-medicine-300969502.html 


 

ALLERGAN ANNOUNCES POSITIVE PHASE 3 ACHIEVE I TRIAL RESULTS FOR UBROGEPANT PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

 https://www.allergan.com/News/Details/2019/12/Allergan%20Announces%20Positive%20Phase%203%20ACHIEVE%20I%20Trial%20Results%20for%20Ubrogepant%20Published%20in%20The%20New%20Engl 

Seeking Biotech Alpha DECEMBER 2019 Insight

New Data Children's Oncology Trial (AALL1331) of BLINCYTO® (Blinatumomab) vs Chemotherapy

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Amgen Announces Data Being Presented At ASH 2019

Mon December 2, 2019 4:00 PM|PR Newswire|About: AMGN

New Data From the Children's Oncology Group Phase 3 Trial (AALL1331) of BLINCYTO® (Blinatumomab) Versus Chemotherapy in First Relapse of Acute Lymphoblastic Leukemia Accepted as Late-Breaking Abstract

Data From Amgen's BiTE® Platform Demonstrate Versatility of Approach Across Four Hematological Malignancies

PR Newswire

THOUSAND OAKS, Calif., Dec. 2, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.prnewswire.com/news-releases/amgen-announces-data-being-presented-at-ash-2019-300967666.html 


 https://www.amgen.com/ 


 https://www.amgen.com/media/news-releases/2019/12/amgen-announces-data-being-presented-at-ash-2019/ 


 https://www.blincyto.com/ 


 https://www.xgeva.com/ 



BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

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Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Tue December 3, 2019 7:30 AM|GlobeNewswire|About: BIIB

  • The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo
  • Positive results support Biogen’s goal of building a multi-franchise portfolio and underscore the company’s discovery and development capabilities

CAMBRIDGE, Mass., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (BIIB) (Nasdaq: BIIB) 


 https://www.biogen.com/en_us/pipeline.html 



TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

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Johnson & Johnson Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism; Launching Multi-Center, Post-Market Clinical Trials Across U.S.

Tue December 3, 2019 9:00 AM|PR Newswire|About: JNJ

-- Two post-market clinical trials initiating across U.S. to demonstrate rotational stability and visual outcomes

-- Nearly half of all cataract patients have astigmatism, yet often remain untreated due to concerns around rotational stability

PR Newswire

SANTA ANA, Calif., Dec. 3, 2019 /PRNewswire/ -- Johnson & Johnson Vision*


 https://www.prnewswire.com/news-releases/johnson--johnson-vision-introduces-tecnis-toric-ii-1-piece-iol-as-new-monofocal-option-for-cataract-patients-with-astigmatism-launching-multi-center-post-market-clinical-trials-across-us-300968149.html 


 https://www.jjvision.com/ 



sacituzumab govitecan

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Immunomedics Resubmits Biologics License Application to the FDA for Sacituzumab Govitecan

Tue December 3, 2019 8:00 AM|GlobeNewswire|About: IMMU

MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Immunomedics,


 https://www.immunomedics.com/ 


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


 https://seekingalpha.com/news/3523378-immunomedics-refiles-u-s-application-for-tnbc-candidate-shares-up-1 



Seeking Biotech Alpha NOVEMBER 2019 Insight

SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

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U.S. FDA Clears SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

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 


 https://www.intuitive.com/en-us 

satralizumab (development code: SA237)

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Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online

Thu November 28, 2019 9:00 PM|Business Wire|About: CHGCY, RHHBY

  • Satralizumab added to baseline immunosuppressant therapy significantly reduced risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD).
  • Satralizumab added to baseline therapy showed a well-tolerated safety profile.
  • SAkuraSky study is a global phase III clinical study for NMOSD patients including aquaporin-4 antibodies (AQP4-IgG) seropositive and seronegative patients 

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/ 


 https://seekingalpha.com/pr/17714138-positive-phase-iii-results-genentech-s-satralizumab-neuromyelitis-optica-spectrum-disorder 


 https://www.businesswire.com/news/home/20191201005237/en/ 

KEYTRUDA® (pembrolizumab)

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

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/ 



Icosapent Ethyl (Vascepa®)

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European Medicines Agency Accepts for Review Marketing Authorization Application for Amarin’s Icosapent Ethyl (Vascepa®) for Reduction of Cardiovascular Risk in High-Risk Patients, as Reflected in REDUCE-IT® Study

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),


 https://amarincorp.com/ 


 https://investor.amarincorp.com/news-releases/news-release-details/european-medicines-agency-accepts-review-marketing-authorization 


 

EMA accepts Amarin's marketing application for icosapent ethyl

Dec. 2, 2019 6:24 AM ET|About: Amarin Corporation plc (AMRN)|By: , SA News Editor 

 https://seekingalpha.com/news/3522821-ema-accepts-amarins-marketing-application-icosapent-ethyl 



Seeking Biotech Alpha NOVEMBER 2019 Insight

KEYTRUDA® (pembrolizumab)

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Merck’s KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

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/ 


 https://www.mrknewsroom.com/news-release/oncology-newsroom/mercks-keytruda-pembrolizumab-now-approved-china-first-line-treatment 

Acthar® Gel (Repository Corticotropin Injection) Therapy

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Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Symptomatic Sarcoidosis Published in Therapeutic Advances in Respiratory Disease

Tue November 26, 2019 6:45 AM|PR Newswire|About: MNK

-- Study showed an association between Acthar Gel treatment and improved overall health status in 95 percent of patients, along with a reduced use of concomitant medications --

-- The analysis showed an association between Acthar Gel treatment and a decrease in mean daily dose of corticosteroids from 18.2 mg to 9.9 mg --

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 


 https://www.prnewswire.com/news-releases/data-on-acthar-gel-repository-corticotropin-injection-therapy-in-symptomatic-sarcoidosis-published-in-therapeutic-advances-in-respiratory-disease-300965058.html 


 http://www.mallinckrodt.com/products/brands/ 


What is Acthar Gel? Acthar® Gel (repository corticotropin injection) is used for: Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus) Treatment of infantile spasms in infants and children under 2 years of age Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease The reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus) Treatment for flares or on a regular basis (maintenance) in people with systemic dermatomyositis or polymyositis (DM-PM) Treatment for people with symptoms of sarcoidosis Adjunctive therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina Acthar is injected beneath the skin or into the muscle.

Agilent Technologies Inc (A). (NYSE: A)

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Agilent Receives Multiple Life Science Industry Awards for Innovation

Tue November 26, 2019 8:00 AM|Business Wire|About: A 


 https://www.agilent.com/ 


 https://www.businesswire.com/news/home/20191126005181/en/ 



elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis= “NASH”

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GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH

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

  • Data Safety Monitoring Board (DSMB) recommends the continuation of the RESOLVE-IT clinical trial without any modifications, based on the pre-planned review of safety data
  • DSMB guidance remains consistent, supporting favorable safety profile of elafibranor

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 


 https://www.amf-france.org/ 


 https://www.genfit.com/ 

QIAGEN and DiaSorin launches QuantiFERON-TB Plus test

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QIAGEN and DiaSorin Receive FDA Approval for The LIAISON QuantiFERON-TB Gold Plus Test on LIAISON Platforms and Begin Commercial Launch

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/ 


 https://www.qiagen.com/us/ 


 https://www.diasorin.com/home/ 

pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor

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Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma

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.incyte.com/ 

 https://www.businesswire.com/news/home/20191127005145/en/ 




Seeking Biotech Alpha NOVEMBER 2019 Insight

Dengue Vaccine Candidate

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Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting

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.takeda.com/ 


 https://www.takedavaccines.com/ 

 https://www.businesswire.com/news/home/20191123005045/en/ 


KarXT = oral xanomeline = muscarinic receptor agonist) & trospium (a muscarinic receptor antagonist)

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Karuna Therapeutics Announces KarXT Met Primary Endpoint in Phase 2 Clinical Trial of Acute Psychosis in Patients with Schizophrenia

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://karunatx.com/ 


 https://seekingalpha.com/news/3520035-karuna-86-percent-premarket-positive-karxt-data 


 https://www.businesswire.com/news/home/20191118005243/en/ 



Novartis nears $7B deal for The Medicines Co.

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Novartis Nears Deal to Buy Cholesterol-Drug Maker The Medicines Co.

Acquisition would help Novartis bulk up in the heart-treatments market

 

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 


 https://www.themedicinescompany.com/ 

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

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FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

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/ 


 https://www.gene.com/ 


 

PIPELINE

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 


ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

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Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

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://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-Announces-Progress-in-Expanding-ADCETRIS-Brentuximab-Vedotin-Indications-in-Canada/default.aspx 


 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/ 


XTANDI® (enzalutamide)

image107

 

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

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.prnewswire.com/news-releases/astellas-announces-the-approval-of-xtandi-enzalutamide-by-the-china-national-medical-products-administration-nmpa-300964935.html 

 https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf 


 

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

 https://www.astellas.com/en/news/15446 




Seeking Biotech Alpha NOVEMBER 2019 Insight

VUMERITY™ (diroximel fumarate) FDA-approved treatment for relapsing forms of multiple sclerosis (MS)

image108

 

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate)

Fri November 22, 2019 7:30 AM|GlobeNewswire|About: BIIB

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB)


 https://www.vumerity.com/content/dam/commercial/vumerity/pat/en_us/pdf/vumerity-prescribing-information.pdf 


 https://seekingalpha.com/news/3521496-biogens-ms-drug-shows-improved-gi-tolerability-vs-tecfidera 


 https://www.vumerity.com/en_us/home.html 


 https://www.biogen.com/ 


 

BIOGEN PRESENTS DATA DEMONSTRATING IMPROVED GASTROINTESTINAL TOLERABILITY WITH VUMERITY™ (DIROXIMEL FUMARATE) COMPARED TO TECFIDERA® (DIMETHYL FUMARATE)

November 22, 2019 at 7:30 AM EST

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)

 http://investors.biogen.com/news-releases/news-release-details/biogen-presents-data-demonstrating-improved-gastrointestinal 

SOLIRIS® (Eculizumab)

image109

 

SOLIRIS® (eculizumab) Receives Approval in Japan for the Prevention of Relapse in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

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.solirisrems.com/ 


 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) Receives Approval In Japan For The Prevention Of Relapse In Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

- 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 -

EmailPDFPrintRSS

BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)

 https://news.alexion.com/press-release/product-news/soliris-eculizumab-receives-approval-japan-prevention-relapse-patients-ne 

PD-L1 IHC 22C3 pharmDx -identifying HNSCC patients for treatment w/ KEYTRUDA® (pembrolizumab) in Eur

image110

 

Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC)

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 



Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)

image111

 

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

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.tecentriq.com/ 


 https://www.avastin.com/ 


 https://www.businesswire.com/news/home/20191122005376/en/ 


 https://www.gene.com/ 

ALUNBRIG® (brigatinib)

image112

  

Takeda Presents Long-Term Data in ALK+ NSCLC Showing ALUNBRIG® (brigatinib) Continues to Demonstrate Superiority in the First-Line After Two Years of Follow-Up

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)

Regeneron Pharmaceuticals (REGN) Presents At Jefferies Global Healthcare Conference - Slideshow

Nov. 22, 2019 2:10 PM ET | About: Regeneron Pharmaceuticals, Inc. (REGN) 



 https://www.businesswire.com/news/home/20191122005494/en/ 


 https://www.takeda.com/ 


 https://www.takeda.com/newsroom/newsreleases/2019/takeda-presents-long-term-data-in-alk-nsclc-showing-alunbrig-brigatinib-continues-to-demonstrate-superiority-in-the-first-line-after-two-years-of-follow-up/ 

Tislelizumab

image113

 

BeiGene Announces Clinical Data on Tislelizumab Presented at European Society for Medical Oncology (ESMO) Asia 2019 Congress

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/ 


 https://www.beigene.com/science-and-product-portfolio/pipeline?loc=US 


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



Seeking Biotech Alpha NOVEMBER 2019 InsighT

Calquence (acalabrutinib)

image115

 

Calquence approved in the US for adult patients with chronic lymphocytic leukaemia

  PUBLISHED21 November 2019

21 November 2019 18:10 BST
 

Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Calquence combined with obinutuzumab and as monotherapy reduced
the risk of disease progression or death by 90% and 80%,
respectively in ELEVATE-TN
 

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.


 

FDA OKs AstraZeneca's Calquence for lymphocytic leukemia

Nov. 21, 2019 2:13 PM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  

 https://seekingalpha.com/news/3521306-fda-oks-astrazenecas-calquence-lymphocytic-leukemia 

SYMPHONY Occipito-Cervico-Thoracic (OCT) System

image116

 

New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders

Thu November 21, 2019 9:02 AM|PR Newswire|About: JNJPR Newswire

NEW YORK, Nov. 21, 2019 /PRNewswire/ -- The Johnson & Johnson Medical Devices Companies* 


 https://www.prnewswire.com/news-releases/new-cervical-spine-system-from-depuy-synthes-advances-treatment-options-for-patients-with-complex-cervical-spine-disorders-300963037.html 


 https://www.jnjmedicaldevices.com/en-US/news-events/new-cervical-spine-system-depuy-synthes-advances-treatment-options-patients-complex 

IN.PACT™ AV drug-coated balloon

image117

 

Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions

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)



 

IN.PACT Admiral Drug-Coated Balloon

Paclitaxel Coated Balloon

 https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/drug-coated-balloons/inpact-drug-coated-balloon.html 


 

Medtronic lands FDA approval for renal disease treatment

Nov. 21, 2019 11:13 AM ET|About: Medtronic plc (MDT)|By: , SA News Editor  

 https://seekingalpha.com/news/3521268-medtronic-lands-fda-approval-renal-disease-treatment 

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

image118

 

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

Thu November 21, 2019 8:30 AM|PR Newswire|About: ABBV

- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)

- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)

- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

PR Newswire

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-research-in-the-treatment-of-leukemias-lymphomas-and-other-blood-cancers-at-2019-ash-annual-meeting-300962704.html 


 https://www.imbruvica.com/ 


 https://www.venclextahcp.com/cll.html 

Otezla® (apremilast)

image119

 

Amgen Completes Acquisition Of Otezla® (apremilast)

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.


 

Amgen Completes Acquisition Of Otezla® (apremilast)

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/ 


 https://www.prnewswire.com/news-releases/amgen-completes-acquisition-of-otezla-apremilast-300962932.html 

Seeking Biotech Alpha NOVEMBER 2019 Insight

KEYTRUDA® (pembrolizumab)

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European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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.keytruda.com/ 


 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 


 

European advisory group backs new regimens of Merck's Keytruda

Oct. 18, 2019 7:19 AM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor  

 https://seekingalpha.com/news/3506829-european-advisory-group-backs-new-regimens-mercks-keytruda 

investigational therapy tepotini

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Merck KGaA, Darmstadt, Germany, Announces Orphan Drug Designation for Investigational Therapy Tepotinib in Patients with NSCLC Harboring MET Gene Alterations

Wed November 20, 2019 2:00 AM|PR Newswire|About: MKKGY 


 https://www.prnewswire.com/news-releases/merck-kgaa-darmstadt-germany-announces-orphan-drug-designation-for-investigational-therapy-tepotinib-in-patients-with-nsclc-harboring-met-gene-alterations-300961630.html 


 https://www.emdgroup.com/en 


 https://www.emdgroup.com/en/research.html 


 SOURCE Merck KGaA (MKGAY

Tumor Treating Fields

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Novocure Announces 43 Presentations on Tumor Treating Fields at 24th Annual Meeting of the Society for Neuro-Oncology

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)


 https://www.businesswire.com/news/home/20191120005453/en/ 

Lilly Technology Center

image124

 

Lilly announces $400 million capital investment in manufacturing facilities in Indianapolis

Wed November 20, 2019 6:30 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Nov. 20, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.prnewswire.com/news-releases/lilly-announces-400-million-capital-investment-in-manufacturing-facilities-in-indianapolis-300961247.html 

Givlaari (givosiran)

image125


 

FDA approves first treatment for inherited rare disease

 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/ 


 

FDA OKs Alnylam's givosiran for AHP

Nov. 20, 2019 12:36 PM ET|About: Alnylam Pharmaceutical... (ALNY)|By: , SA News Editor  

 https://seekingalpha.com/news/3520900-fda-oks-alnylams-givosiran-ahp 



 https://www.alnylam.com/ 

Seeking Biotech Alpha NOVEMBER 2019 Insight

icosapent ethyl (Vascepa®)

image127



 https://www.abstractsonline.com/pp8/#!/7891/presentation/35097  

Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions

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 


SB8 Bevacizumab Biosimilar

image128

 

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

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 



ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug

image129

 

Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder

Tue November 19, 2019 7:00 AM|PR Newswire|About: ALKS

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)


 https://www.prnewswire.com/news-releases/alkermes-submits-new-drug-application-to-us-food-and-drug-administration-for-alks-3831-for-treatment-of-schizophrenia-and-bipolar-i-disorder-300960407.html 


 

Alkermes plc (ALKS) Investor Presentation - Sliideshow

Nov. 20, 2019 5:13 AM ET | About: Alkermes plc (ALKS) 

 https://seekingalpha.com/article/4307949-alkermes-plc-alks-investor-presentation-sliideshow 

DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone

image130

 

Genmab Announces European Marketing Authorization for DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma

Tue November 19, 2019 11:14 AM|GlobeNewswire|About: GMAB

Company Announcement

  • DARZALEX® approved in Europe in combination with lenalidomide and dexamethasone as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
  • Approval follows positive opinion by European Committee for Medicinal Products for Human Use (CHMP) in October
  • Approval based on data from Phase III MAIA study

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 



Ubrogepant 50 mg and 25 mg

image131

Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association

Tue November 19, 2019 11:22 AM|PR Newswire|About: AGN

-- Acute treatment of migraine with ubrogepant compared with placebo led to significantly greater rates of pain freedom at two hours with both the 50 mg and 25 mg doses, and freedom from the most bothersome migraine-associated symptom at two hours with the 50 mg dose --

-- FDA action on New Drug Application (NDA) expected in December 2019 for ubrogepant, potentially making it the first oral CGRP to address unmet patient needs in acute treatment of migraine and the first FDA-approved gepant --

PR Newswire

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Allergan plc (AGN)


 https://www.allergan.com/News/Details/2019/11/Allergan%20Announces%20Positive%20Phase%203%20ACHIEVE%20II%20Trial%20Results%20for%20Ubrogepant%20Published%20in%20The%20Journal 


 https://www.prnewswire.com/news-releases/allergan-announces-positive-phase-3-achieve-ii-trial-results-for-ubrogepant-published-in-the-journal-of-the-american-medical-association-300961106.html 



Seeking Biotech Alpha NOVEMBER 2019 Insight

Perjeta (pertuzumab)

image132

 

Genentech to Present New and Updated Data for Seven Approved and Investigational Medicines Across Multiple Types of Breast Cancer at the 2019 San Antonio Breast Cancer Symposium

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.herceptin.com/ 


 https://www.gene.com/download/pdf/herceptin_prescribing.pdf 


 https://www.businesswire.com/news/home/20191117005086/en/ 


 https://www.gene.com/ 

Leronlimab (PRO 140)

image133

 

CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in March 2020

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://www.cytodyn.com/newsroom/press-releases/detail/356/cytodyn-treats-first-patient-in-phase-1b2-clinical-trial 


 https://seekingalpha.com/symbol/CYDY 


PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

image134

 

Ontario and Quebec provide reimbursement for HIV therapies PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

Mon November 18, 2019 7:00 AM|Canada Newswire|About: MRK

  • Although treatment progress has been made, human immunodeficiency virus (HIV) is still one of the world's most serious public health challenges.i In 2018, approximately 37.9 million people were living with HIV worldwide.ii During that same year, an estimated 1.7 million people became newly infected globally.iii
  • For more than 30 years, Merck (MRK) has been committed to scientific research and discovery in HIV that addresses unmet medical needs and helps people living with HIV have a long and healthy life.

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). 

 https://www.delstrigo.com/ 

vericiguat, a soluble guanylate cyclase (sGC) stimulator

image137

 

Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

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/ 


 https://seekingalpha.com/news/3520021-merck-bayers-vericiguat-successful-late-stage-heart-failure-study 


https://www.mrknewsroom.com/news-release/research-and-development-news/merck-and-bayers-investigational-drug-vericiguat-meets-pr

Seeking Biotech Alpha NOVEMBER 2019 Insight

REVLIMID® (lenalidomide) in combination with rituximab (R²)

image138

 

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

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/ 


 https://www.celgene.com/ 


 https://revlimidrrfl.com/patient/ 

Repatha® (evolocumab)

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Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Sat November 16, 2019 9:00 AM|PR Newswire|About: AMGNPR Newswire

THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.ashx 

 

Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Additional FOURIER Analysis Shows Lowering LDL-C With Repatha Did Not Impair Patient-Reported Cognition

THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen

 https://www.amgen.com/media/news-releases/2019/11/amgen-announces-new-fourier-analysis-showing-benefit-of-repatha-evolocumab-in-highrisk-patients-who-have-experienced-a-recent-heart-attack/ 

FARXIGA (dapagliflozin)

image141


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/consistent-effects-of-farxiga-in-heart-failure-patients-with-reduced-ejection-fraction-shown-in-new-analyses-from-landmark-phase-iii-dapa-hf-trial-11172019.html  

Consistent Effects of FARXIGA in Heart Failure Patients With Reduced Ejection Fraction Shown in New Analyses From Landmark Phase III DAPA-HF Trial

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 


 

Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

 https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg 


 https://www.businesswire.com/news/home/20191117005052/en/ 


BRILINTA (ticagrelor)

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Subgroup Analysis of TWILIGHT Trial Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Who Underwent PCI Showed BRILINTA Monotherapy Reduced the Risk of Clinically Relevant Bleeding Compared With Dual Antiplatelet Therapy (DAPT)

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/ 


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/subgroup-analysis-of-twilight-trial-patients-with-non-st-elevation-acute-coronary-syndrome-nste-acs-who-underwent-pci-showed-brilinta-monotherapy-reduced-the-risk-of-clinically-relevant-bleeding-compared-with-dual-antiplatelet-therapy-dapt-11172019.html 


Seeking Biotech Alpha NOVEMBER 2019 Insight

Vosoritide (BMN 111) for Achondroplasia

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BioMarin Announces Cumulative Additional Height Gain of 9.0 cm over 54 months versus Natural History in Children with Achondroplasia Treated with Vosoritide in Phase 2 Study

Thu November 14, 2019 8:27 AM|PR Newswire|About: BMRN

Company Presents Data Confirming that the Phase 3 and Phase 2 Study Participants have Similar Baseline Parameters

PR Newswire

SAN RAFAEL, Calif., Nov. 14, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN


 https://www.prnewswire.com/news-releases/biomarin-announces-cumulative-additional-height-gain-of-9-0-cm-over-54-months-versus-natural-history-in-children-with-achondroplasia-treated-with-vosoritide-in-phase-2-study-300958408.html 


 https://clinicaltrials.gov/ct2/show/NCT02724228?cond=Achondroplasia&lead=biomarin&phase=12&draw=2&rank=1 


 https://investors.biomarin.com/2019-11-14-BioMarin-Announces-Cumulative-Additional-Height-Gain-of-9-0-cm-over-54-months-versus-Natural-History-in-Children-with-Achondroplasia-Treated-with-Vosoritide-in-Phase-2-Study 



MEK 1/2 inhibitor selumetinib

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US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review

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 


 https://www.mrknewsroom.com/news-release/oncology/us-fda-accepts-regulatory-submission-new-drug-application-selumetinib-neurofib 



Vascepa (icosapent ethyl)

 

FDA Ad Com thumbs up on CV benefit of Amarin's Vascepa

Nov. 14, 2019 4:09 PM ET|About: Amarin Corporation plc (AMRN)|By: , SA News Editor  


 

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

Thu November 14, 2019 5:34 PM|GlobeNewswire|About: AMRN 

 https://seekingalpha.com/pr/17700484-amarin-announced-fda-advisory-committee-voted-unanimously-16minus-0-recommend-approval 



 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 


 https://investor.amarincorp.com/news-releases/news-release-details/amarin-announced-fda-advisory-committee-voted-unanimously-16-0 


 

AHA: Amarin's Vascepa halts progression of arterial plaque in key study

by Kyle Blankenship | Nov 17, 2019 5:32pm 

 https://www.fiercepharma.com/pharma/aha-amarin-s-vascepa-halts-progression-arterial-plaque-interim-imaging-data 

BRUKINSA™ (zanubrutinib)

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U.S. FDA Grants BeiGene’s BRUKINSA™ (zanubrutinib) Accelerated Approval to Treat Adult Patients with Mantle Cell Lymphoma Who Received at Least One Prior Therapy

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 


 https://www.beigene.com/products 

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin)

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Qtrilmet approved in the EU for the treatment of type-2 diabetes

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.


15 November 2019 07:00 GMT
 

Seeking Biotech Alpha NOVEMBER 2019 Insight

RINVOQ™ (upadacitinib)

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New Positive Data for RINVOQ™ (upadacitinib) on Signs and Symptoms in Patients with Ankylosing Spondylitis Presented at 2019 ACR/ARP Annual Meeting

Tue November 12, 2019 11:15 AM|PR Newswire|About: ABBV

- Full results were presented today at the 2019 ACR/ARP Annual Meeting in Atlanta

- The safety profile was consistent with that of previous studies across indications, with no new safety risks detected[1,2]

- Affecting more than five million people worldwide, AS is a chronic inflammatory disease that causes pain and stiffness in the joints, mainly in the spine[3,4]

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 


 https://www.prnewswire.com/news-releases/new-positive-data-for-rinvoq-upadacitinib-on-signs-and-symptoms-in-patients-with-ankylosing-spondylitis-presented-at-2019-acrarp-annual-meeting-300956524.html 

Northern Ireland will have access to ORKAMBI® (lumacaftor/ivacaftor), SYMKEVI®, KALYDECO®

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Vertex Confirms Northern Ireland Offer Accepted for Cystic Fibrosis Medicines

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/ 


 https://www.orkambi.com/ 



INGREZZA® (valbenazine)

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Neurocrine Biosciences Publishes Long-Term INGREZZA® (valbenazine) Data in the Journal of Clinical Psychopharmacology Demonstrating Once-Daily 40 mg and 80 mg Capsules Reduced Involuntary Movements in Adults with Tardive Dyskinesia

Tue November 12, 2019 4:01 PM|PR Newswire|About: NBIX

- INGREZZA Continues to Be Well Tolerated Through One Year of Treatment

PR Newswire

SAN DIEGO, Nov. 12, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)


 https://www.prnewswire.com/news-releases/neurocrine-biosciences-publishes-long-term-ingrezza-valbenazine-data-in-the-journal-of-clinical-psychopharmacology-demonstrating-once-daily-40-mg-and-80-mg-capsules-reduced-involuntary-movements-in-adults-with-tardive-dyskinesi-300956831.html 


 https://www.neurocrine.com/pipeline/pipeline-overview/ 


 https://www.ingrezza.com/PI 


 https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-publishes-long-term-ingrezzar-valbenazine 

Rubraca® (rucaparib)

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Clovis Oncology Announces Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Italy

Wed November 13, 2019 4:00 AM|Business Wire|About: CLVS 

 

  • Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
  • Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rucaparib now reimbursed in several countries in Europe with additional countries to follow in 2020

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/ 


Nucala (mepolizumab)

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13 November 2019

Nucala (mepolizumab) is the first treatment to show a significant reduction in flares for patients with Hypereosinophilic Syndrome (HES)

Positive data from a pivotal study supports new regulatory filing in HES

Issued: London, UK

GlaxoSmithKline plc (GSK)


 

Glaxo's Nucala successful in pivotal HES study

Nov. 13, 2019 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 

 https://seekingalpha.com/news/3518541-glaxos-nucala-successful-pivotal-hes-study 

Seeking Biotech Alpha NOVEMBER 2019 Insight

Risdiplam

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Genentech’s Risdiplam Meets Primary Endpoint in Pivotal SUNFISH Trial in People With Type 2 or 3 Spinal Muscular Atrophy

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

Roche signs agreement with PTC Therapeutics to advance treatment for Spinal Muscular Atrophy (SMA)

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 


 https://www.gene.com/ 

NIS4, an Investigational Non-Invasive NASH Diagnostic

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GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019

Sun November 10, 2019 8:00 AM|GlobeNewswire|About: GNFT

GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019

  • NIS4 is GENFIT’s innovative non-invasive in vitro diagnostic test, or IVD, to identify patients with NASH who may be appropriate candidates for drug therapy
  • Program is based on the in-house discovery of a 4-biomarker algorithm potentially replacing biopsy with a single blood test
  • Study finds patients living with type 2 diabetes are at increased risk of being diagnosed with NASH

Lille (France), Cambridge (Massachusetts, United States), November 10, 2019 – GENFIT (Nasdaq and Euronext: GNFT)


 https://www.genfit.com/ 


 https://ir.genfit.com/news-releases/news-release-details/genfit-announces-results-nis4-investigational-non-invasive-nash 



Ervebo

image156

 (Reuters)  

HEALTH NEWSNOVEMBER 11, 2019 / 12:48 PM / UPDATED 2 HOURS AGO

Merck wins European approval for first-ever Ebola vaccine

 Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila 



 

Merck Ebola vaccine OK'd in Europe

Nov. 11, 2019 1:59 PM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor  

 

Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

Mon November 11, 2019 3:00 PM|Business Wire|About: MRK 

 

Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

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 

XELJANZ® (tofacitinib)

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Seeking Biotech Alpha NOVEMBER 2019 Insight

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination

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U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma

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 


 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-0 

Vascepa® (icosapent ethyl)

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REDUCE-IT® USA Results, in Prespecified Subgroup Analyses of Landmark REDUCE-IT Global Study, Showed Robust Cardiovascular Risk Reductions Across a Variety of Study Endpoints, Including Cardiovascular Death and All-Cause Mortality

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 


 https://amarincorp.com/ 


 https://investor.amarincorp.com/news-releases/news-release-details/reduce-itr-usa-results-prespecified-subgroup-analyses-landmark 

ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

image163

 

Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

Mon November 11, 2019 7:30 AM|PR Newswire|About: AGN 

 PR Newswire

DUBLIN, Nov. 11, 2019 /PRNewswire/ -- Allergan plc (AGN)


 https://www.prnewswire.com/news-releases/allergan-receives-fda-qualified-infectious-disease-product-qidp-designation-and-fast-track-designation-for-atm-avi-aztreonam-and-avibactam-for-antibiotic-resistant-gram-negative-infections-300955166.html 


 https://www.combacte.com/about/about-combacte-care-detail/ 

MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study Micra™ Transcatheter Pacing

image165

 

New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker

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)


 http://newsroom.medtronic.com/news-releases/news-release-details/new-study-shows-promise-treating-more-patients-worlds-smallest 

Seeking Biotech Alpha NOVEMBER 2019 Insight

REBLOZYL® (luspatercept-aamt)

image166

 

FDA Approves REBLOZYL® (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions

Fri November 8, 2019 12:33 PM|Business Wire|About: CELG, XLRN

REBLOZYL is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients

Approval of REBLOZYL marks the first FDA-approved treatment for anemia in beta thalassemia

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Celgene Corporation (CELG) and Acceleron Pharma Inc. (XLRN)


 https://www.businesswire.com/news/home/20191108005496/en/ 


 https://www.clinicaltrials.gov/ct2/show/NCT03682536?term=COMMANDS+luspatercept&rank=1 


 https://www.clinicaltrials.gov/ct2/show/NCT03342404?term=BEYOND&cond=Beta-Thalassemia&rank=2 

GAZYVA® (obinutuzumab)

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Genentech’s Gazyva (obinutuzumab), in Combination With Standard of Care, More Than Doubles the Percentage of Lupus Nephritis Patients Achieving Complete Renal Response, Compared to Standard of Care Alone

Sat November 9, 2019 4:30 PM|Business Wire|About: RHHBY

—NOBILITY Phase II study showed 40% of patients treated with Gazyva plus standard of care achieved complete renal response at week 76, compared to 18% of patients treated with placebo plus standard of care—

—Gazyva also met key secondary efficacy endpoints—

—Genentech plans to initiate enrollment in a Phase III study in 2020—

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


 https://www.gene.com/patients/advancing-inclusive-research 


 https://www.businesswire.com/news/home/20191109005043/en/ 


 https://www.gene.com/media/press-releases/14821/2019-11-09/genentechs-gazyva-obinutuzumab-in-combin 

Nektar Therapeutics Presents New Clinical and Preclinical Data from its Immuno-Oncology Pipeline

image169

 

Nektar Therapeutics Presents New Clinical and Preclinical Data from its Immuno-Oncology Pipeline at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Sat November 9, 2019 5:30 PM|PR Newswire|About: NKTR 

 

Additional Preclinical Data Presentations Showcase Nektar's Immuno-Oncology (I-O) Pipeline Programs

PR Newswire

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


 https://www.prnewswire.com/news-releases/nektar-therapeutics-presents-new-clinical-and-preclinical-data-from-its-immuno-oncology-pipeline-at-the-2019-society-for-immunotherapy-of-cancer-sitc-annual-meeting-300955155.html 


 https://www.nektar.com/ 


Amarin Corporation plc

image170

 
Amarin Announces FDA Notification of Advisory Committee Meeting Planned to be Held in November 2019 in Connection With Vascepa® REDUCE-IT™ sNDA 

 August 08, 2019 16:30 ET | Source: Amarin Corporation plc

PDUFA Date Extension to End of December 2019 Expected

Management to Host Conference Call Today at 7:00 p.m. ET

BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN)

 

More articles issued by Amarin Corporation plc
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Seeking Biotech Alpha NOVEMBER 2019 Insight

Acthar® Gel (Repository Corticotropin Injection)

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Mallinckrodt Announces Data Publication on the Treatment Effectiveness of Acthar® Gel (Repository Corticotropin Injection) for Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan Population

Thu November 7, 2019 6:45 AM|PR Newswire|About: MNK 

 PR Newswire

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


 https://www.prnewswire.com/news-releases/mallinckrodt-announces-data-publication-on-the-treatment-effectiveness-of-acthar-gel-repository-corticotropin-injection-for-resolution-of-multiple-sclerosis-relapse-in-a-us-health-plan-population-300953458.html 


 http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26271 


NINLARO™ (ixazomib)

image172

 

Phase 3 Trial of NINLAROTM (ixazomib) as First Line Maintenance Therapy Met Primary Endpoint in Multiple Myeloma Patients not treated with Stem Cell Transplantation

Thu November 7, 2019 8:00 AM|Business Wire|About: TAK

- Results Demonstrated Statistically Significant Improvement in Progression-Free Survival -

- Data to be Submitted for Presentation at an Upcoming Medical Meeting -

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


 https://clinicaltrials.gov/ct2/show/NCT02312258 


 https://www.takeda.com/newsroom/newsreleases/2019/phase-3-trial-of-ninlaro-ixazomib-as-first-line-maintenance-therapy-met-primary-endpoint-in-multiple-myeloma-patients-not-treated-with-stem-cell-transplantation/ 

Harmony® Test - The first non-invasive prenatal test

image173

 

Harmony® Test: The first non-invasive prenatal test approved by Health Canada

Thu November 7, 2019 7:31 AM|Canada Newswire|About: CHGCY, RHHBY

Canadian women now have access to an approved non-invasive prenatal test

LAVAL, QC, Nov. 7, 2019 /CNW Telbec/


 https://harmonytest.com/en/non-invasive-prenatal-test-nipt.html 

Roxadustat

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Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients with Anemia in Phase III OLYMPUS and ROCKIES Trials

Thu November 7, 2019 4:35 PM|Business Wire|About: AZN

OLYMPUS demonstrated a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo

ROCKIES demonstrated a mean increase of 0.77g/dL averaged over weeks 28 to 52, compared to 0.68g/dL with epoetin alfa

WILMINGTON, Del.--(BUSINESS WIRE)


 https://www.businesswire.com/news/home/20191107005774/en/ 


 https://www.fibrogen.com/roxadustat/ 


 https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-presents-phase-3-efficacy-and-safety-results-roxadustat 


 

Roxadustat Phase III Program Pooled Analyses Showed Positive Efficacy and No Increased Cardiovascular Risk in Patients with Anemia from Chronic Kidney Disease Versus Comparators

Fri November 8, 2019 2:02 PM|Business Wire|About: AZN

In non dialysis-dependent patients receiving roxadustat, the risk of MACE, MACE+ and all-cause mortality was comparable to placebo

Dialysis-dependent patients receiving roxadustat had a lower risk of MACE+ and no increased risk of MACE or all-cause mortality versus epoetin alfa

In incident dialysis patients, roxadustat had a lower risk of MACE and MACE+ and showed a trend towards lower risk of all-cause mortality relative to epoetin alfa

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN)

 https://seekingalpha.com/pr/17693400-roxadustat-phase-iii-program-pooled-analyses-showed-positive-efficacy-increased 

Seeking Biotech Alpha NOVEMBER 2019 Insight

Descovy For PrEP™

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Gilead Presents 96-week Discover Trial Data Supporting Non-inferior Efficacy and Key Safety Differences of Descovy For PrEP™ Compared With Truvada For PrEP®

Wed November 6, 2019 6:45 AM|Business Wire|About: GILD

– Results Continue to Demonstrate Statistically Significant Advantages of Descovy® Over Truvada® for Study Measurements of Bone and Renal Safety –

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


 https://www.businesswire.com/news/home/20191106005417/en/ 


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

CALQUENCE® (acalabrutinib)

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CALQUENCE® Data To Show Improved Progression-Free Survival In Phase III Front-Line Chronic Lymphocytic Leukemia At ASH 2019 Annual Meeting

Wed November 6, 2019 3:16 PM|Business Wire|About: AZN

Robust early-stage pipeline advancements and presentations across multiple scientific platforms demonstrate potential to improve treatment outcomes in blood cancers with high unmet need

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca will present the first data from the Phase III ELEVATE-TN trial assessing CALQUENCE® (acalabrutinib)


 https://www.businesswire.com/news/home/20191106005922/en/ 


 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-data-to-show-improved-progression-free-survival-in-phase-iii-front-line-chronic-lymphocytic-leukaemia-trial-at-ash-2019-annual-meeting.html 



 https://www.astrazeneca-us.com/ 

Tetravalent Immunization against Dengue Efficacy Study (TIDES)

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Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure

Wed November 6, 2019 5:00 PM|Business Wire|About: TAK

− New England Journal of Medicine publishes primary endpoint analysis from ongoing Phase 3 study of Takeda’s dengue vaccine candidate

− Over 20,000 study participants in dengue-endemic areas in Latin America and Asia received two doses of Takeda’s dengue vaccine candidate or placebo administered three months apart

− Results demonstrated overall vaccine efficacy of 80.2% (12-month follow-up after second dose) against virologically confirmed dengue; exploratory analyses of secondary endpoints showed 82.2% vaccine efficacy among baseline seropositives and 74.9% vaccine efficacy among baseline seronegatives; the vaccine candidate was generally well tolerated with no important safety risks observed to date

− Formal assessment of secondary efficacy endpoints (18-month follow-up after second dose) will be presented later this year; safety and efficacy will be assessed over a total of four and a half years

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


 https://clinicaltrials.gov/ct2/show/record/NCT02747927?term=den-301&rank=1&view=record 


 https://www.businesswire.com/news/home/20191106005751/en/ 

ORENCIA® (abatacept)

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Bristol-Myers Squibb Underscores Precision-Focused Immunology Leadership with New Data on ORENCIA® (abatacept) in Early RA, ACPA-Positive Patients Presented at 2019 ACR/ARP Annual Meeting¹

Thu November 7, 2019 6:59 AM|Business Wire|About: BMY 

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


 http://packageinserts.bms.com/pi/pi_orencia.pdf 


 https://www.businesswire.com/news/home/20191107005257/en/ 



Seeking Biotech Alpha NOVEMBER 2019 Insight

Seattle Genetics, Inc. (SGEN)

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Seattle Genetics to Present at Credit Suisse 28th Annual Healthcare Conference

Mon November 4, 2019 8:00 AM|Business Wire|About: SGEN 


 https://www.businesswire.com/news/home/20191104005240/en/ 


 https://www.seattlegenetics.com/ 

Oligomannate (GV-971)

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 China Conditionally Approves ‘Seaweed Drug’ for Alzheimer’s

By Ding Yi / Nov 04, 2019 12:34 PM / Society & Culture

 Shanghai Green Valley Pharmaceuticals 


 http://www.nmpa.gov.cn/WS04/CL2056/359779.html 


 http://www.cas.cn/syky/201911/t20191103_4722432.shtml 


 http://en.zjsfq.gov.cn/2016-01/29/c_49112.htm 


 

Green Valley Pharmaceutical Company has submitted New Drug Applications and Market Authorization to China Food and Drug Administration (CFDA) for Sodium Oligomannurarate (GV-971)

BARCELONA, Spain, Oct. 25, 2018 /PRNewswire/ -- Green Valley Pharmaceutical Co., Ltd. (Headquarter: Shanghai)

 https://www.prnewswire.com/news-releases/novel-drug-treatment-shows-improved-cognition-in-a-phase-3-clinical-trial-in-persons-with-mild-to-moderate-alzheimers-disease-in-china-300737649.html 


Immunology Portfolio and Pipeline

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AbbVie to Showcase Depth of Immunology Portfolio and Pipeline at the 2019 ACR/ARP Annual Meeting

Mon November 4, 2019 8:31 AM|PR Newswire|About: ABBV 


 https://clinicaltrials.gov/ct2/show/NCT03104374 


 https://www.prnewswire.com/news-releases/abbvie-to-showcase-depth-of-immunology-portfolio-and-pipeline-at-the-2019-acrarp-annual-meeting-300950462.html 

Jardiance® (empagliflozin) in type 2 diabetes, heart failure, and chronic kidney disease.

Boehringer Ingelheim and Lilly modernise alliance to focus full expertise on Jardiance®
Mon November

 

Boehringer Ingelheim and Lilly modernise alliance to focus full expertise on Jardiance®

Mon November 4, 2019 9:00 AM|PR Newswire|About: LLY

- Alliance to focus combined expertise and investment to maximise Jardiance® for people with type 2 diabetes, heart failure, and chronic kidney disease

- Alliance to continue to include three product families – empagliflozin, linagliptin and insulin glargine

INGELHEIM, Germany, and INDIANAPOLIS, Nov. 4, 2019 /PRNewswire/


 Jardiance® (empagliflozin) in type 2 diabetes, heart failure, and chronic kidney disease. Trajenta® (linagliptin) and Basaglar® (insulin glargine) 

 Trajenta® (linagliptin) and Basaglar® (insulin glargine) continue to be part of the Alliance, with primary responsibility for development and commercialisation led by the innovator company. Boehringer Ingelheim will continue as strategic lead for Trajenta®, and Lilly for Basaglar®. 


 https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-modernise-alliance-to-focus-full-expertise-on-jardiance-300950132.html