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  • COMPANY NEWS: Flexion's Zilretta data sufficient for submission

    Flexion Therapeutics Inc. (NASDAQ:FLXN) gained $5.78 (50%) to $17.23 after it said FDA endorsed the company's plans to submit an NDA for osteoarthritis (OA) pain therapy Zilretta (FX006) based on existing data. In a …

    Published on 5/26/2016
  • COMPANY NEWS: FDA panel backs Sanofi's iGlarLixi

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 to recommend approval of Type II diabetes therapy iGlarLixi from Sanofi (Euronext:SAN: NYSE:SNY), a fixed ratio combination of lixisenatide (ZP10) …

    Published on 5/25/2016
  • COMPANY NEWS: Vitesse launches first newco Thunderbolt

    Vitesse Biologics LLC (South San Francisco, Calif.) launched virtual newco Thunderbolt Pharma Inc. (South San Francisco, Calif.), which will house a preclinical dual antagonist program targeting BLyS (BAFF) and tumor …

    Published on 5/25/2016
  • COMPANY NEWS: WuXi, Huawei launch precision medicine infrastructure

    The WuXi NextCODE subsidiary of New WuXi Life Science Ltd. (Shanghai, China) and Huawei Technologies Co. Ltd. (Shenzhen, China) launched the China Precision Medicine Cloud technology infrastructure, which is intended to…

    Published on 5/24/2016
  • COMPANY NEWS: Young returning to Gilead as COO

    Gilead Sciences Inc. (NASDAQ:GILD) named Kevin Young COO. He was Gilead's EVP of commercial operations from 2004-14, and has been an advisor to the company since then. Gilead said Paul Carter, who has been EVP of …

    Published on 5/24/2016
  • COMPANY NEWS: Arbor acquiring XenoPort

    Specialty pharma Arbor Pharmaceuticals Inc. (Atlanta, Ga.) is acquiring XenoPort Inc. (NASDAQ:XNPT) for $7.03 per share, or about $467 million. The deal will give Arbor rights to Horizant gabapentin enacarbil, which is …

    Published on 5/23/2016
  • COMPANY NEWS: Darzalex gets conditional European approval

    The European Commission granted conditional approval to Darzalex daratumumab from Johnson & Johnson (NYSE:JNJ) to treat relapsed and refractory multiple myeloma (MM) in adults whose prior therapy included a proteasome …

    Published on 5/23/2016
  • COMPANY NEWS: FDA reviewers question Sanofi's iGlarLixi

    In briefing documents released ahead of an advisory committee meeting to discuss two Type II diabetes treatments from Sanofi (Euronext:SAN; NYSE:SNY), FDA reviewers again raised concerns about a combination therapy …

    Published on 5/23/2016
  • COMPANY NEWS: FDA to review Samsung Bioepis' Remicade biosimilar

    Samsung Bioepis Co. Ltd. said FDA accepted its BLA for SB2, a biosimilar of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ).The BLA is the first submitted in the U.S. by Samsung Bioepis, a JV …

    Published on 5/23/2016
  • COMPANY NEWS: Witz among departing Sanofi execs

    Sanofi (Euronext:SAN; NYSE:SNY) said three executives will leave the company, including EVP of Diabetes and Cardiovascular Pascale Witz. Last year, Sanofi had named Witz to the post as part of a global reorganization (…

    Published on 5/23/2016
  • COMPANY NEWS: Avalon launches cancer play PDI Therapeutics

    Avalon Ventures launched cancer immunotherapy play PDI Therapeutics Inc. (La Jolla, Calif.) as part of an expanded build-to-buy partnership with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The newco is the first Avalon has…

    Published on 5/20/2016
  • COMPANY NEWS: Otonomy gains on CMS coverage decision

    Otonomy Inc. (NASDAQ:OTIC) gained $2.07 (18%) to $13.76 Friday after it said CMS assigned a C-code and approved transitional pass-through reimbursement for Otiprio ciprofloxacin otic suspension. The billing code becomes…

    Published on 5/20/2016
  • COMPANY NEWS: 3SBio, Hengrui withdraw biosimilar applications

    3SBio Inc. (HKSE:1530) and Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) each withdrew NDAs for biosimilars from China FDA review, citing review policies instituted last year that require sponsors to self-inspect …

    Published on 5/19/2016
  • COMPANY NEWS: Diabetes newco Islexa launched

    The U.K.'s Cell and Gene Therapy Catapult (CGT) and University of Aberdeen formed newco Islexa Ltd. to develop cell therapy technology to treat Type I diabetes.The technology would enable reprogramming of donor …

    Published on 5/19/2016
  • COMPANY NEWS: FDA panel to discuss Remoxy

    Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics Inc. (NASDAQ:PTIE) said FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet Aug. 5 to discuss Pain's NDA for …

    Published on 5/19/2016
  • COMPANY NEWS: NICE rebuffs Perjeta for neoadjuvant use

    In new draft guidance, the U.K.'s NICE recommended against use of Perjeta pertuzumab from Roche (SIX:ROG; OTCQX:RHHBY) in combination with the pharma's Herceptin trastuzumab and docetaxel for the neoadjuvant treatment …

    Published on 5/19/2016
  • COMPANY NEWS: J&J, MacroGenics in second antibody deal

    MacroGenics Inc. (NASDAQ:MGNX) jumped $3.02 (17%) to $21.06 on Wednesday after granting the Janssen Biotech Inc. unit of Johnson & Johnson exclusive, worldwide rights to MGD015, a preclinical bispecific antibody against…

    Published on 5/18/2016
  • COMPANY NEWS: EC approves Actelion's Uptravi

    The European Commission approved Uptravi selexipag from Actelion Ltd. (SIX:ATLN) to treat pulmonary arterial hypertension (PAH). Actelion has rights to the long-acting prostacyclin (IP) receptor (PGI2; PTGIR) agonist …

    Published on 5/17/2016
  • COMPANY NEWS: Epstein leaving Novartis amid pharma reorganization

    Novartis AG (NYSE:NVS; SIX:NOVN) said it will split its pharmaceuticals division into two new units, Novartis Pharmaceuticals and Novartis Oncology, which together will form Novartis' new Innovative Medicines division. …

    Published on 5/17/2016
  • COMPANY NEWS: Management tracks

    Acute and intensive care company The Medicines Co. (NASDAQ:MDCO) named Tony Kingsley president and COO. He was EVP of global commercial operations at Biogen Inc. (NASDAQ:BIIB). Cancer company Kite Pharma Inc. (NASDAQ:…

    Published on 5/17/2016
  • COMPANY NEWS: Opdivo approved quickly for first hematological cancer

    FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat classical Hodgkin's lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell …

    Published on 5/17/2016
  • COMPANY NEWS: PTAB institutes Coherus' IPR challenge to Humira

    Coherus BioSciences Inc. (NASDAQ:CHRS) gained $2.58 (16%) to $18.85 on Tuesday after the U.S. Patent Trial and Appeal Board instituted its inter partes review petition challenging a patent covering autoimmune drug …

    Published on 5/17/2016
  • COMPANY NEWS: Amgen sues Sandoz over Neulasta biosimilar

    In a lawsuit, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) infringed two patents protecting Neulasta pegfilgrastim. FDA accepted Sandoz's BLA in November 2015 for LA-EP2006, …

    Published on 5/16/2016
  • COMPANY NEWS: Biogen bolsters gene therapy portfolio

    Biogen Inc. (NASDAQ:BIIB) and the University of Pennsylvania will collaborate to develop gene therapies for eye, skeletal muscle and CNS conditions. Biogen will pay $20 million up front to UPenn, which is to develop …

    Published on 5/16/2016
  • COMPANY NEWS: EC approves Alprolix

    The European Commission approved Alprolix eftrenonacog alfa to treat and prevent bleeding in hemophilia B patients. Swedish Orphan Biovitrum AB (SSE:SOBI) has rights to the drug from Biogen Inc. (NASDAQ:BIIB) in Europe,…

    Published on 5/13/2016

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