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  • COMPANY NEWS: Aduro using Stanford tech in next-generation LADDs

    Aduro Biotech Inc. (NASDAQ:ADRO) said it gained an exclusive license to neoantigen identification technology from Stanford University. Aduro plans to use the technology to engineer personalized Listeria-based …

    Published on 1/19/2017
  • COMPANY NEWS: BMS cuts expectations for Opdivo/Yervoy combo

    Bristol-Myers Squibb Co. (NYSE:BMY) said that it no longer plans to seek accelerated approval of Opdivo nivolumab in combination with Yervoy ipilimumab as a first-line treatment for lung cancer. The company said it …

    Published on 1/19/2017
  • COMPANY NEWS: FDA again reviewing Shire's triple-bead ADHD therapy

    Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA accepted for review a resubmitted NDA for SHP465 to treat ADHD. Its PDUFA date is June 20.Shire hopes to launch SHP465 next half. It consists of three-component, extended …

    Published on 1/19/2017
  • COMPANY NEWS: FDA approves Imbruvica in marginal zone lymphoma

    FDA granted accelerated approval to Imbruvica ibrutinib from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) to treat relapsed or refractory marginal zone lymphoma (MZL), a type of non-Hodgkin's lymphoma (NHL).…

    Published on 1/19/2017
  • COMPANY NEWS: FDA approves Synergy's constipation drug

    FDA approved once-daily oral Trulance plecanatide from Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) to treat chronic idiopathic constipation (CIC) in adults. Spokesperson Gem Hopkins told BioCentury that Synergy plans to …

    Published on 1/19/2017
  • COMPANY NEWS: GSK names Miels president of global pharmaceuticals

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) named Luke Miels president of global pharmaceuticals. Miels will succeed Abbas Hussain, who will leave the company later this year. Hussain has held the position since October …

    Published on 1/19/2017
  • COMPANY NEWS: Boehringer's biosimilar Humira under FDA, EMA review

    Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA and EMA accepted for review regulatory applications for BI 695501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). In October, …

    Published on 1/18/2017
  • COMPANY NEWS: Management tracks

    Cancer company Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) named Richard Peters president and CEO, effective Feb. 6. He was SVP and head of global rare diseases at the Genzyme unit of Sanofi (Euronext:SAN; NYSE:SNY).…

    Published on 1/18/2017
  • COMPANY NEWS: Takeda, Ovid team to develop epilepsy candidate

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Ovid Therapeutics Inc. (New York, N.Y.) partnered to develop the Japanese pharma's TAK-935. Takeda has completed four Phase I studies of the candidate, and the partners …

    Published on 1/18/2017
  • COMPANY NEWS: Biogen pays it Forward in $1.25B deal

    Forward Pharma A/S (NASDAQ:FWP) gained $8.85 (48%) to $27.20 after it said it will receive $1.25 billion from Biogen Inc. (NASDAQ:BIIB) as part of a licensing and settlement agreement related to the companies' patent …

    Published on 1/17/2017
  • COMPANY NEWS: Management tracks

    Rare diseases company Swedish Orphan Biovitrum AB (SSE:SOBI) said CEO Geoffrey McDonough will leave the company on July 1. The company is searching for a replacement. The company also named Armin Reininger SVP and head …

    Published on 1/13/2017
  • COMPANY NEWS: Tesaro gets CRL for IV rolapitant

    Tesaro Inc. (NASDAQ:TSRO) received a complete response letter from FDA for biotech's IV formulation of rolapitant (SCH 619734) to prevent chemotherapy-induced nausea and vomiting (CINV).At FDA's request during the NDA …

    Published on 1/12/2017
  • COMPANY NEWS: FDA reviewing Herceptin biosimilar from Mylan, Biocon

    Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said FDA accepted for review a BLA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab to treat HER2-positive breast cancer. The BsUFA date …

    Published on 1/11/2017
  • COMPANY NEWS: NICE recommends Afinitor for second-line RCC

    In draft guidance issued Wednesday, the U.K.'s NICE recommended that Afinitor everolimus from Novartis AG (NYSE:NVS; SIX:NOVN) be routinely available on the NHS to treat advanced renal cell carcinoma that progressed …

    Published on 1/11/2017
  • COMPANY NEWS: Priority Review for Keytruda in broad NSCLC indication

    Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab in a broader first-line non-small cell lung cancer indication than that for which the drug is already …

    Published on 1/11/2017
  • COMPANY NEWS: Vertex grants Merck KGaA rights to cancer programs

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) granted Merck KGaA (Xetra:MRK) exclusive, worldwide rights to four cancer programs. Vertex is to receive $230 million up front and is eligible for royalties. Merck will be …

    Published on 1/11/2017
  • COMPANY NEWS: Illumina rises after introducing new products, deals

    Illumina Inc. (NASDAQ:ILMN) gained $23.50 (17%) to $165.04 on Tuesday after introducing new products and collaborations, including the launch of the NovaSeq series of high throughput sequencers. The company said the …

    Published on 1/10/2017
  • COMPANY NEWS: Kite, Fosun create China-based JV

    Kite Pharma Inc. (NASDAQ:KITE) and Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) formed a joint venture to develop Kite's lead chimeric antigen receptor (CAR) T cell immunotherapy candidate, …

    Published on 1/10/2017
  • COMPANY NEWS: Valeant selling Dendreon to Chinese conglomerate

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) is selling cancer company Dendreon Pharmaceuticals Inc. to Sanpower Group Co. Ltd. (Nanjing, China) for $819.9 million in cash. Valeant expects the deal to …

    Published on 1/10/2017
  • COMPANY NEWS: Allergan in deals with Lysosomal Therapeutics, Assembly

    Allergan plc (NYSE:AGN) announced two deals Monday, gaining an exclusive option to acquire neurodegenerative disease company Lysosomal Therapeutics Inc. (Cambridge, Mass.) and a license for rights to four …

    Published on 1/9/2017
  • COMPANY NEWS: Amgen, Immatics in bispecifics deal

    Amgen Inc. (NASDAQ:AMGN) and Immatics Biotechnologies GmbH (Tuebingen, Germany) partnered to develop T cell engaging bispecific immunotherapies to treat cancer. Immatics is to receive $30 million up front and is …

    Published on 1/9/2017
  • COMPANY NEWS: Celgene partners with Anokion, lifts 2017 guidance

    Celgene Corp. (NASDAQ:CELG) and Anokion S.A. (Ecublens, Switzerland) partnered to use the Swiss biotech's immune tolerizing platform to develop therapies for autoimmune diseases. Celgene made an equity investment in …

    Published on 1/9/2017
  • COMPANY NEWS: Daiichi gets Japan rights to Kite's CAR T

    Kite Pharma Inc. (NASDAQ:KITE) said it granted Daiichi Sankyo Co. Ltd. (Tokyo:4568) rights in Japan to develop and commercialize chimeric antigen receptor T cell therapy axicabtagene ciloleucel (KTE-C19).Kite is to …

    Published on 1/9/2017
  • COMPANY NEWS: FDA approves Egalet's Arymo

    FDA approved Arymo ER morphine sulfate extended-release from Egalet Corp. (NASDAQ:EGLT) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment …

    Published on 1/9/2017
  • COMPANY NEWS: Ipsen acquiring Merrimack's marketed products

    Ipsen Group (Euronext:IPN; Pink:IPSE) is acquiring the commercial business of Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) for $575 million up front and up to $450 million in milestones. The deal includes U.S. rights to…

    Published on 1/9/2017

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