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  • COMPANY NEWS: JAMA study finds Harvoni cost-effective

    A study published Monday in JAMA Internal Medicine found that HCV drug Harvoni sofosbuvir/ledipasvir from Gilead Sciences Inc. (NASDAQ:GILD) was cost-effective across all ranges of disease severity.The study assessed …

    Published on 11/24/2015
  • COMPANY NEWS: Lilly's NSCLC drug among host of approvals

    FDA and EMA each approved multiple drugs early this week, including the first approval for Portrazza necitumumab (LY3012211) from Eli Lilly and Co.(NYSE:LLY). FDA approved Portrazza in combination with chemotherapy as a…

    Published on 11/24/2015
  • COMPANY NEWS: Turing offers hospitals Daraprim discount

    Turing Pharmaceuticals AG (Zug, Switzerland) said it will provide discounts of up to 50% to hospitals on the price of toxoplasmosis drug Daraprim pyrimethamine, but will not cut the drug's list price.The company came …

    Published on 11/24/2015
  • COMPANY NEWS: Uni-Bio, Jiangsu Hansoh in diabetes deal

    Uni-Bio Science Group Ltd. (HKSE:690) gained exclusive, worldwide rights to mitiglinide from Jiangsu Hansoh Pharmaceutical Co. Ltd. (Lianyungang, China). Uni-Bio said China FDA has approved the insulin secretagogue as a…

    Published on 11/24/2015
  • COMPANY NEWS: CVS picks Amgen's Repatha

    CVS Health Corp. (NYSE:CVS) has selected Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) as its exclusive PCSK9 inhibitor in exchange for undisclosed discounts on the lipid-lowering mAb."We have determined that …

    Published on 11/23/2015
  • COMPANY NEWS: FDA approves Opdivo in RCC

    FDA approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval came well in advance of the drug's …

    Published on 11/23/2015
  • COMPANY NEWS: Zai gets China rights to Hanmi's EGFR inhibitor

    Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) granted Zai Laboratory Ltd. (Shanghai, China) exclusive rights in China to HM61713 to treat EGFR mutation-positive non-small cell lung cancer (NSCLC). The deal includes …

    Published on 11/23/2015
  • COMPANY NEWS: AZ, Sanofi swap 210,000 compounds

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Sanofi (Euronext:SAN; NYSE:SNY) said they will exchange 210,000 chemical compounds from their libraries. The partners said no payments were associated with the transfer, and there…

    Published on 11/20/2015
  • COMPANY NEWS: CHMP backs Enbrel biosimilar, UCB epilepsy candidate

    EMA's CHMP recommended approval of Benepali etanercept (SB4) from Samsung Bioepis Co. Ltd., a biosimilar of Enbrel etanercept for a host of autoimmune indications. The committee also recommended approval of Briviact …

    Published on 11/20/2015
  • COMPANY NEWS: Express Scripts to calculate 'blended' drug prices

    Express Scripts Holding Co. (NASDAQ:ESRX) CMO Steve Miller said the company will create a "blended price" for drugs as part of its new indication-based pricing scheme. At an HHS forum on prescription drug pricing, …

    Published on 11/20/2015
  • COMPANY NEWS: FDA approves genetically modified salmon

    FDA approved AquAdvantage Salmon from AquaBounty Technologies Inc. (LSE:ABTX). The Atlantic salmon is genetically engineered to reach market size more quickly than non-genetically engineered farm-raised Atlantic salmon.…

    Published on 11/20/2015
  • COMPANY NEWS: KaloBios names Shkreli CEO, revives leukemia program

    KaloBios Pharmaceuticals Inc. (NASDAQ:KBIO) gained $7.85 (75%) to $18.25 on Friday, continuing its rise after a group led by Martin Shkreli invested in the company. The company named Shkreli chairman and CEO after …

    Published on 11/20/2015
  • COMPANY NEWS: Takeda gets quick FDA nod for MM drug Ninlaro

    FDA approved Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat multiple myeloma (MM), months ahead of its March 10, 2016, PDUFA date. The agency approved Ninlaro in combination with Revlimid …

    Published on 11/20/2015
  • COMPANY NEWS: Eiger reverse-merges with Celladon

    Eiger Biopharmaceuticals Inc. (San Carlos, Calif.) will acquire Celladon Corp. (NASDAQ:CLDN) through a reverse merger. Eiger President and CEO David Cory will lead the combined company, which will be named Eiger and …

    Published on 11/19/2015
  • COMPANY NEWS: Ipsen, Interprotein in endocrine disease deal

    Ipsen Group (Euronext:IPN; Pink:IPSEY) and Interprotein Corp. (Osaka, Japan) partnered to develop therapeutic peptides to treat endocrine diseases including Cushing's disease. Ipsen will have an exclusive option to …

    Published on 11/19/2015
  • COMPANY NEWS: Servier, Pfizer split rights to Cellectis' UCART19

    Servier (Neuilly-sur-Seine, France) exercised its option to acquire a worldwide license to UCART19 from Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) and subsequently granted Pfizer Inc. (NYSE:PFE) U.S. rights to the …

    Published on 11/19/2015
  • COMPANY NEWS: Spring Bank, Gilead to test HBV combo

    Spring Bank Pharmaceuticals Inc. (Milford, Mass.) said it will collaborate with Gilead Sciences Inc. (NASDAQ:GILD) to conduct a Phase II trial of Spring Bank's SB 9200 plus Gilead's Viread tenofovir disoproxil fumarate …

    Published on 11/19/2015
  • COMPANY NEWS: FDA accepts BLA for Sandoz's Neulasta biosimilar

    The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted a BLA for LA-EP2006, a proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN), a pegylated granulocyte colony-…

    Published on 11/18/2015
  • COMPANY NEWS: Genentech, Novartis to share ex-U.S. Fovista rights

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) exercised its option to share ex-U.S. rights to wet age-related macular degeneration (AMD) candidate Fovista pegpleranib with Novartis AG (NYSE:NVS; SIX:NOVN). The…

    Published on 11/18/2015
  • COMPANY NEWS: NICE spurns Amgen's Repatha

    The U.K.'s NICE issued draft guidance recommending against the use of Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN), alone or in combination with lipid-lowering therapies, to treat primary hypercholesterolemia or …

    Published on 11/18/2015
  • COMPANY NEWS: AZ prices Tagrisso

    AstraZeneca plc (LSE:AZN; NYSE:AZN) priced non-small cell lung cancer (NSCLC) drug Tagrisso osimertinib (AZD9291) at a wholesale acquisition cost (WAC) of $12,750 per month.AZ spokesperson Michele Meixell said AZ's …

    Published on 11/17/2015
  • COMPANY NEWS: Management tracks

    Hematology and oncology company Nordic Nanovector ASA (OSE:NANO) said CMO Cristina Oliva will resign in January 2016 to pursue other opportunities. The company is searching for a new CMO.Generics and drug delivery play …

    Published on 11/17/2015
  • COMPANY NEWS: Radius stumbles on NDA delay

    Radius Health Inc. (NASDAQ:RDUS) fell $7.67 (11%) to $61.51 on Tuesday after it said it would delay submission of an NDA for osteoporosis treatment abaloparatide-SC (BA058-SC) to the end of 1Q16.On the company's 3Q15 …

    Published on 11/17/2015
  • COMPANY NEWS: Array licenses two cancer compounds to Pierre Fabre

    Array BioPharma Inc. (NASDAQ:ARRY) granted Laboratoires Pierre Fabre S.A. (Castres, France) exclusive rights to binimetinib (MEK162) and encorafenib (LGX818) in Europe, Latin America and most Asian territories. Both …

    Published on 11/16/2015
  • COMPANY NEWS: FDA approves Darzalex for MM

    FDA granted accelerated approval to Darzalex daratumumab from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GEN; Pink:GMXAY) to treat multiple myeloma. The agency approved the human …

    Published on 11/16/2015

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