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  • TOP STORY: Biogen, AC Immune swing on AD readouts

    Biogen Inc. (NASDAQ:BIIB) shares seesawed Thursday and Friday, propelled upward by data showing that aducanumab (BIIB037) cleared amyloid plaques and improved cognition in an exploratory analysis of a Phase Ib study to …

    Published on 12/9/2016
  • TOP STORY: FDA cautious about real-world evidence

    A great deal of work will be required to pave the road for the use of real world evidence in regulatory decisions, wrote FDA Commissioner Robert Califf and 14 other FDA staff members in a commentary published Thursday …

    Published on 12/8/2016
  • TOP STORY: Trump drug pricing remarks sink biotech stocks

    Biotech stocks slumped Wednesday after Time magazine published an interview with Donald Trump in which the president-elect said he would lower drug prices, without saying how he plans to do so.The BioCentury 100 Index …

    Published on 12/7/2016
  • TOP STORY: BCMA-targeting therapies in ASH spotlight

    At the American Society of Hematology meeting in San Diego, presentations late Monday highlighted data from Phase I studies of two candidates targeting tumor necrosis factor (TNF) receptor superfamily member 17 (BCMA; …

    Published on 12/6/2016
  • TOP STORY: Kite, Novartis update CAR T timelines at ASH

    Kite Pharma Inc. (NASDAQ:KITE) and Novartis AG (NYSE:NVS; SIX:NOVN) each provided updates on their lead chimeric antigen receptor (CAR) T cell therapies targeting CD19. Updates for both programs, which are nearing FDA …

    Published on 12/5/2016
  • TOP STORY: Celgene acquiring Acetylon after spinout of newco

    Acetylon Pharmaceuticals Inc. (Boston, Mass.) said Celgene Corp. (NASDAQ:CELG) will acquire it for undisclosed terms. Prior to the deal's completion, Acetylon will spin out some histone deacetylase (HDAC) assets into …

    Published on 12/2/2016
  • TOP STORY: Impel raising $36M series C round

    Drug delivery company Impel NeuroPharma Inc. (Seattle, Wash.) raised $21 million in the first tranche of a planned $36 million series C round from new investors venBio, 5AM Ventures and Vivo Capital. The company is …

    Published on 12/1/2016
  • TOP STORY: bluebird CAR T therapy leads to responses in MM study

    bluebird bio Inc. (NASDAQ:BLUE) added $8.65 (14%) to $69 in early after-hours trading after it reported interim results from a Phase I study of bb2121 to treat relapsed or refractory multiple myeloma. Among nine …

    Published on 11/30/2016
  • TOP STORY: Arrowhead prunes pipeline over toxicity concerns

    Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) sank $2.63 (60%) to $1.76 in early after-hours trading after it said will discontinue development of all programs using its EX1 liver-targeted, IV delivery vehicle for its …

    Published on 11/29/2016
  • TOP STORY: Amicus again slows migalastat's NDA timeline

    Amicus Therapeutics Inc. (NASDAQ:FOLD) shed $2.29 (28%) to $6.03 in early after-hours trading Monday after it revealed a new timeline for its planned NDA submission for migalastat (AT1001) to treat Fabry's disease. The …

    Published on 11/28/2016
  • TOP STORY: Lilly's solanezumab fails third Phase III Alzheimer's test

    Eli Lilly and Co. (NYSE:LLY) lost nearly $9 billion in market cap on Wednesday when it said it was abandoning efforts to submit solanezumab (LY2062430) for regulatory approval to treat mild dementia in Alzheimer's …

    Published on 11/23/2016
  • TOP STORY: Novo, Sanofi win diabetes approvals

    FDA approved two combination therapies to treat Type II diabetes, Xultophy 100/3.6 insulin degludec/liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) and Soliqua 100/33 insulin glargine/lixisenatide from Sanofi (…

    Published on 11/22/2016
  • TOP STORY: Novartis opts in, buys sickle cell company Selexys

    Novartis AG (NYSE:NVS; SIX:NOVN) exercised its option to acquire hematologic and inflammatory company Selexys Pharmaceuticals Corp. (Oklahoma City, Okla.) for $240 million. Under a 2012 deal, the pharma held the option …

    Published on 11/21/2016
  • TOP STORY: BeiGene preps for Phase III with follow-on

    As it prepares to conduct a Phase III study of its lead candidate, cancer company BeiGene Ltd. (NASDAQ:BGNE) raised $185 million in a bumped-up follow-on of ADSs underwritten by Morgan Stanley, Goldman Sachs, Cowen, …

    Published on 11/18/2016
  • TOP STORY: Praluent CVOT to continue

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SYN) said they will continue to conduct a cardiovascular outcomes trial of hypercholesterolemia drug Praluent alirocumab after an independent …

    Published on 11/17/2016
  • TOP STORY: Amgen's anti-CGRP migraine therapy heads for submission

    Amgen Inc. (NASDAQ:AMGN) and Novartis AG (NYSE:NVS; SIX:NOVN) said both doses of erenumab (AMG 334) met the primary endpoint in the Phase III STRIVE trial to prevent episodic migraine. From baseline to week 24, 70 mg …

    Published on 11/16/2016
  • TOP STORY: Medicines Co., Alnylam PCSK9 heading for Phase III

    In an interim analysis of the Phase II ORION-1 trial, The Medicines Co. (NASDAQ:MDCO) and Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said short interfering RNA therapy inclisiran (ALN-PCSsc; PCSK9si) led to sustained …

    Published on 11/15/2016
  • TOP STORY: Corbus gains on scleroderma results

    Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) jumped $3 (51%) to $8.85 on Monday after announcing positive top-line data from the Phase II JBT101-SSc-001 trial of Resunab (JBT-101) to treat diffuse cutaneous …

    Published on 11/14/2016
  • TOP STORY: PTC gains after CHMP backs Translarna renewal

    PTC Therapeutics Inc. (NASDAQ:PTCT) gained $5.30 (88%) to $11.30 on Friday after EMA's CHMP recommended renewal of the conditional marketing authorization for Translarna ataluren to treat Duchenne muscular dystrophy (…

    Published on 11/11/2016
  • TOP STORY: BMS's NASH portfolio grows via deal for Nitto's siRNA

    Nitto Denko Corp. (Tokyo:6988) granted Bristol-Myers Squibb Co. (NYSE:BMY) an exclusive, worldwide license to clinical candidate ND-L02-s0201 to treat liver diseases including non-alcoholic steatohepatitis (NASH). The …

    Published on 11/10/2016
  • TOP STORY: Biotech stocks spike after election

    Biotech stocks rose sharply on Wednesday following the U.S. election, easily outpacing the gains seen in the broader markets. The BioCentury 100 was up 417.03 (8.7%) to 5,209.84, with gainers outnumbering decliners by …

    Published on 11/9/2016
  • TOP STORY: Valeant slammed on FDA, earnings

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) fell C$5.59 (22%) to C$19.92 in Toronto on Tuesday, and lost $4.15 (22%) to $14.98 in New York after disclosing FDA has extended by three months its review …

    Published on 11/8/2016
  • TOP STORY: Spinraza passes latest Phase III SMA test

    Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said Spinraza nusinersen met the primary endpoint of the Phase III CHERISH trial to treat later-onset spinal muscular atrophy. In an interim readout…

    Published on 11/7/2016
  • TOP STORY: Solithera narrowly wins panel's risk/benefit vote

    FDA's Antimicrobial Drugs Advisory Committee voted 7-6 that the efficacy of oral and IV Solithera solithromycin from Cempra Inc. (NASDAQ:CEMP) outweighs their hepatotoxicity risk in the treatment of community acquired …

    Published on 11/4/2016
  • TOP STORY: bluebird slips after latest LentiGlobin update

    bluebird bio Inc. (NASDAQ:BLUE) lost $5.10 (11%) to $41.30 after reporting new results from three Phase I/II studies of LentiGlobin BB305 gene therapy, which the company is developing to treat sickle cell disease (SCD) …

    Published on 11/3/2016

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