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21039 items
4:38 PM, Oct 19, 2018  |  BC Extra | Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE. FDA...
4:32 PM, Oct 19, 2018  |  BC Extra | Company News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Friday that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The company also...
3:42 PM, Oct 19, 2018  |  BC Extra | Company News

FDA approves Dupixent for asthma

FDA approved Dupixent dupilumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat moderate to severe eosinophilic or corticosteroid-dependent asthma in patients ages 12 and older. Sanofi said the drug’s wholesale acquisition cost (WAC)...
3:35 PM, Oct 19, 2018  |  BC Extra | Company News

Management tracks: AbbVie, Adverum

AbbVie Inc. (NYSE:ABBV) said EVP and CFO William Chase will retire in mid-2019. Effective immediately, Chase becomes EVP of finance and administration until his retirement and VP and Controller Robert Michael will succeed Chase as...
3:09 PM, Oct 18, 2018  |  BC Extra | Company News

AbbVie, Morphic partner on antifibrotic integrins

AbbVie Inc. (NYSE:ABBV) agreed to pay Morphic Therapeutic (Waltham, Mass.) $100 million up front for exclusive options to license antifibrotic integrins to block transforming growth factor (TGF) β activation via multiple undisclosed targets. Morphic is responsible...
1:10 PM, Oct 18, 2018  |  BC Extra | Company News

WideTrial seeks to increase expanded access programs by helping companies recover costs

FDA has authorized WideTrial Inc. (San Francisco, Calif.) to charge payment for an expanded access program for critical limb ischemia (CLI) candidate PLX-PAD from Pluristem Therapeutics Inc. (NASDAQ:PSTI; Tel Aviv:PSTI) under a cost recovery program....
12:57 PM, Oct 18, 2018  |  BC Extra | Company News

Management tracks: Autolus, Bayer, Cambridge Allergy

T cell cancer therapy company Autolus Therapeutics plc (NASDAQ:AUTL) hired Adam Hacker as SVP for regulatory affairs and quality, a newly created position. Previously, he was VP, head of vaccines and scientific innovation projects, global...
10:47 AM, Oct 18, 2018  |  BC Extra | Company News

Novartis buys Endocyte for $2.1B, gets radioligand therapy for prostate cancer

Novartis AG (NYSE:NVS; SIX:NOVN) will acquire cancer company Endocyte Inc. (NASDAQ:ECYT) for about $2.1 billion in cash. The deal gives Novartis 177Lu-PSMA-617, a radioligand therapy in the Phase III VISION trial to treat prostate-specific membrane...
7:01 AM, Oct 18, 2018  |  BC Extra | Company News

Xyphos, Parker Institute steer next-gen CAR T therapies into solid tumors

Xyphos Biosciences Inc. (South San Francisco, Calif.) will partner with the Parker Institute for Cancer Immunotherapy to develop CAR Ts using Xyphos' convertibleCAR platform. Xyphos President and CEO Jim Knighton told BioCentury the research will...
4:16 PM, Oct 17, 2018  |  BC Extra | Company News

Express Scripts adds Aimovig, Emgality to new value-based migraine program; excludes Ajovy

Express Scripts Holding Co. (NASDAQ:ESRX) will include two of three FDA approved migraine prevention drugs in its value-based program for migraine, which it unveiled Wednesday. The PBM gave the nod to Aimovig erenumab-aooe from Amgen...