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  • COMPANY NEWS: NeuroDerm shortens regulatory path for PD candidate

    NeuroDerm Ltd. (NASDAQ:NDRM) gained $4.10 (26%) to $19.65 on Monday after revealing a new regulatory path in the U.S. for ND0612 to treat Parkinson's disease. ND0612 delivers liquid levodopa/carbidopa continuously via a…

    Published on 12/5/2016
  • COMPANY NEWS: Sanofi invests in JHL, gets biosimilar rights

    JHL Biotech Inc. (TPex-E:6540) granted Sanofi (Euronext:SAN: NYSE:SNY) rights in China to develop and commercialize biosimilar rituximab (JHL1101), as well as options for rights to other JHL candidates. JHL is to …

    Published on 12/5/2016
  • COMPANY NEWS: Jardiance label adds CV risk indication

    FDA approved Jardiance empagliflozin from Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY) to reduce the risk of cardiovascular death in adults with Type II diabetes and cardiovascular …

    Published on 12/2/2016
  • COMPANY NEWS: Management tracks

    Prescription and OTC pharma Taro Pharmaceutical Industries Ltd. (NYSE:TARO) said Uday Baldota will replace Kal Sundaram as its CEO, effective April 2017. Baldota is EVP and CFO at Sun Pharmaceutical Industries Ltd. (BSE…

    Published on 12/2/2016
  • COMPANY NEWS: Bicycle, AZ in bicyclic peptide deal

    Bicycle Therapeutics Ltd. (Cambridge, U.K.) and AstraZeneca plc (LSE:AZN; NYSE:AZN) partnered to identify and develop bicyclic peptides to treat respiratory, cardiovascular and metabolic diseases. Bicyclic peptides are …

    Published on 12/1/2016
  • COMPANY NEWS: Keytruda gets FDA review in cHL, NICE nod in NSCLC

    Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab to treat refractory classical Hodgkin's lymphoma, or cHL in patients who relapsed after three or more prior…

    Published on 12/1/2016
  • COMPANY NEWS: Parker Institute, CRI form neoantigen initiative

    The Parker Institute for Cancer Immunotherapy and the Cancer Research Institute (New York, N.Y.) announced a partnership to improve algorithms used to identify cancer neoantigens. Nonprofit organization Sage Bionetworks…

    Published on 12/1/2016
  • COMPANY NEWS: Boehringer forges hearing loss research deal in China

    Boehringer Ingelheim GmbH (Ingelheim, Germany) said it will collaborate with the China Southeast University Institute of Life Sciences to develop regenerative therapies to treat hearing loss. The collaboration is part …

    Published on 11/29/2016
  • COMPANY NEWS: FDA panel to discuss Neurocrine's Ingrezza

    Neurocrine Biosciences Inc. (NASDAQ:NBIX) said FDA's Psychopharmacologic Drugs Advisory Committee will meet on Feb. 16, 2017, to discuss the company's NDA for Ingrezza valbenazine to treat tardive dyskinesia. The NDA is…

    Published on 11/29/2016
  • COMPANY NEWS: Priority Review for avelumab in metastatic MCC

    Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) said FDA accepted and granted Priority Review to a BLA for avelumab (MSB0010718C) to treat metastatic Merkel cell carcinoma. The partners said the mAb against PD-L1 …

    Published on 11/29/2016
  • COMPANY NEWS: Actelion says J&J discussed deal

    Actelion Ltd. (SIX:ATLN) acknowledged in a statement Friday that Johnson & Johnson (NYSE:JNJ) has approached it "about a possible transaction." Actelion declined further comment. The company markets hypertension drugs …

    Published on 11/28/2016
  • COMPANY NEWS: FDA drops Veltassa's black box warning

    The Relypsa Inc. unit of Vifor Pharma Ltd. (Zurich, Switzerland) said FDA approved an sNDA that removes a black box warning from the label of Veltassa patiromer. The warning addressed potential drug-drug interactions, …

    Published on 11/28/2016
  • COMPANY NEWS: NICE recommends Imbruvica, Imnovid

    In updated guidance documents, the U.K.'s NICE recommended routine use of Imbruvica ibrutinib from Johnson & Johnson (NYSE:JNJ) and AbbVie Inc. (NYSE:ABBV) to treat chronic lymphocytic leukemia (CLL), and recommended …

    Published on 11/28/2016
  • COMPANY NEWS: Priority Review for Keytruda in MSI-H cancer

    Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab to treat advanced microsatellite instability-high (MSI-H) cancer. Its PDUFA date is March 8, 2017.Merck is …

    Published on 11/28/2016
  • COMPANY NEWS: Takeda's Ninlaro gets conditional approval in EU

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said the European Commission conditionally approved Ninlaro ixazomib in combination with Revlimid lenalidomide and dexamethasone to treat adults with multiple myeloma who …

    Published on 11/28/2016
  • COMPANY NEWS: Allergan acquires Chase

    Allergan plc (NYSE:AGN) said it acquired Chase Pharmaceuticals Corp. (Washington, D.C.) for $125 million up front, plus milestones tied to the company's lead candidate, CPC-201, to treat Alzheimer's disease. Allergan …

    Published on 11/22/2016
  • COMPANY NEWS: Intarcia submits diabetes implant, gets $100M milestone

    Intarcia Therapeutics Inc. (Boston, Mass.) submitted an NDA to FDA for ITCA 650 to treat Type II diabetes. The submission triggered a $100 million milestone payment to Intarcia under a 2015 royalty deal (see BioCentury,…

    Published on 11/21/2016
  • COMPANY NEWS: Quick FDA approval for Darzalex in second-line MM

    Genmab A/S (CSE:GEN) said FDA approved Darzalex daratumumab in combination with dexamethasone and either Revlimid lenalidomide or Velcade bortezomib to treat multiple myeloma in patients who have received at least one …

    Published on 11/21/2016
  • COMPANY NEWS: Celgene opts in for Triphase's proteasome inhibitor

    Triphase Accelerator Corp. (San Diego, Calif.) said Celgene Corp. (NASDAQ:CELG) exercised its option to acquire Triphase's proteasome inhibitor marizomib (NPI-0052). Triphase will receive an undisclosed upfront payment,…

    Published on 11/18/2016
  • COMPANY NEWS: Complete response letter for Spectrum's Qapzola

    Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it received a complete response letter from FDA for its non-muscle invasive bladder cancer (NMIBC) candidate Qapzola apaziquone. Based on discussions with the agency, …

    Published on 11/18/2016
  • COMPANY NEWS: Gilead ends GlobeImmune HBV deal

    GlobeImmune Inc. (Pink:GMIB) said Gilead Sciences Inc. (NASDAQ:GILD) returned rights to HBV candidate GS-4774 and terminated a 2011 partnership to develop HBV vaccines. The companies had hoped to create vaccines based …

    Published on 11/18/2016
  • COMPANY NEWS: Management tracks

    Hematology and oncology company Nordic Nanovector ASA (OSE:NANO) named Lisa Rojkjaer CMO. She was global clinical program head in oncology global development at Novartis AG (NYSE:NVS; SIX:NOVN). Biogen Inc. (NASDAQ:BIIB…

    Published on 11/18/2016
  • COMPANY NEWS: Gruenenthal buys oral formulation company Thar

    Gruenenthal Group (Aachen, Germany) acquired drug formulation company Thar Pharmaceuticals Inc. (Pittsburgh, Pa.). The companies did not disclose financial terms, and did not respond to inquiries.Thar's Enhance …

    Published on 11/17/2016
  • COMPANY NEWS: J&J submits BLA for guselkumab

    Johnson & Johnson (NYSE:JNJ) said it submitted a BLA to FDA for guselkumab (CNTO 1959) to treat moderate to severe plaque psoriasis. The submission triggers an undisclosed milestone payment to MorphoSys AG (Xetra:MOR; …

    Published on 11/17/2016
  • COMPANY NEWS: Management tracks

    Diagnostics company Exact Sciences Corp. (NASDAQ:EXAS) promoted Jeff Elliott to CFO from VP of business development and strategy. He replaces the retiring John Bakewell.Neurology company vasopharm GmbH (Wuerzburg, …

    Published on 11/17/2016

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