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  • TOP STORY: Biogen hammered after slashing guidance

    Biogen Inc. (NASDAQ:BIIB) sank $85.02 (22%) to $300.03, losing $20 billion in market cap Friday after it lowered its 2015 guidance for EPS and sales growth, primarily because the company expects sales of multiple …

    Published on 7/24/2015
  • TOP STORY: FDA discourages Sunesis from submitting NDA

    Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS) plunged $2.01 (58%) to $1.46 in after-hours trading Thursday after it said FDA "did not support" submission of an NDA for Qinprezo vosaroxin to treat acute myelogenous leukemia…

    Published on 7/23/2015
  • TOP STORY: Latest results mixed for Biogen's aducanumab

    Biogen Inc. (NASDAQ:BIIB) said a 6 mg/kg dose of aducanumab (BIIB037) significantly reduced beta amyloid levels, but did not significantly slow cognitive decline, in the Phase Ib PRIME trial to treat prodromal or mild …

    Published on 7/22/2015
  • TOP STORY: EC approves Amgen's PCSK9 inhibitor

    Amgen Inc. (NASDAQ:AMGN) said the European Commission approved an MAA for Repatha evolocumab to treat several groups of patients with high cholesterol. The approval is the first anywhere for a PCSK9 inhibitor. Repatha …

    Published on 7/21/2015
  • TOP STORY: Opdivo, Cometriq meet in Phase III mRCC trials

    Bristol-Myers Squibb Co. (NYSE:BMY) and Exelixis Inc. (NASDAQ:EXEL) each reported results Monday from Phase III trials of therapies to treat metastatic renal cell carcinoma (RCC).BMS stopped the Phase III CheckMate -025…

    Published on 7/20/2015
  • TOP STORY: Gilead narrows criteria for HCV drugs access program

    Gilead Sciences Inc. (NASDAQ:GILD) has narrowed the eligibility criteria for Support Path, its patient access program for HCV treatments Sovaldi sofosbuvir and Harvoni ledipasvir/sofosbuvir. The program offers co-pay …

    Published on 7/17/2015
  • TOP STORY: Woodford, Malin join Immunocore's $320M A round

    Immunocore Ltd. (Abingdon, U.K.) raised $320 million in a series A round, the largest European biotech venture round on record. New investors Woodford Investment Management LLP, Malin Corp. plc (ISE:MLC) and Eli Lilly …

    Published on 7/16/2015
  • TOP STORY: Sanofi unveils global reorganization

    Sanofi (Euronext:SAN; NYSE:SNY) said it will reorganize the company into five global business units. The realignment is Sanofi's first major move since Olivier Brandicourt took over as CEO in April. The company will …

    Published on 7/15/2015
  • TOP STORY: Celgene buying Receptos for $7.2B

    Celgene Corp. (NASDAQ:CELG) will acquire Receptos Inc. (NASDAQ:RCPT) for $232 per share in cash, or $7.2 billion net of Receptos' cash. The price represents a 12% premium to Receptos' Tuesday close and a 45% premium to …

    Published on 7/14/2015
  • TOP STORY: Anacor soars on Phase III dermatitis data

    Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) jumped $47.32 (56%) to $131.93 on Monday after its crisaborole (AN2728) met the primary and secondary endpoints in two Phase III trials to treat atopic dermatitis. Anacor plans …

    Published on 7/13/2015
  • TOP STORY: Biogen R&D head Williams leaving for start-up

    Biogen Inc. (NASDAQ:BIIB) said EVP of R&D Douglas Williams will leave the company at the end of July to become CEO of an undisclosed start-up focused on cancer diagnostics and therapy. Williams will be the newco's first…

    Published on 7/10/2015
  • TOP STORY: Celgene, Epizyme extend HMT collaboration

    Celgene Corp. (NASDAQ:CELG) and partner Epizyme Inc. (NASDAQ:EPZM) extended their existing research collaboration by three years, giving Celgene options to license Epizyme's histone methyltransferase inhibitors against …

    Published on 7/9/2015
  • TOP STORY: White House opposes key parts of 21st Century Cures Act

    A White House statement released Wednesday applauds the goals of the 21st Century Cures Act (H.R. 6) but criticizes the ways it seeks to achieve them. The statement says the White House "administration looks forward to …

    Published on 7/8/2015
  • TOP STORY: Novartis' Entresto approved for heart failure

    FDA approved Entresto sacubitril/valsartan (LCZ696) from Novartis AG (NYSE:NVS; SIX:NOVN) to reduce the risk of cardiovascular death and hospitalization for heart failure in chronic heart failure patients with reduced …

    Published on 7/7/2015
  • TOP STORY: Versartis rises after FDA removes clinical hold

    Versartis Inc. (NASDAQ:VSAR) gained $4.30 (29%) to $18.92 on Monday after FDA lifted a partial clinical hold on the Phase III VELOCITY study of VRS-317, a long-acting recombinant human growth hormone (rhGH) to treat …

    Published on 7/6/2015
  • TOP STORY: FDA approves Vertex's Orkambi for CF

    FDA approved Orkambi ivacaftor/lumacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis patients aged 12 and older homozygous for the F508 mutation of the CF transmembrane conductance regulator…

    Published on 7/2/2015
  • TOP STORY: Baxalta makes its debut

    Baxter International Inc. (NYSE:BAX) spun out its innovative biopharmaceuticals unit, Baxalta Inc. (NYSE:BXLT), as a separate public company. In its first day of trading on Wednesday, Baxalta shares lost $0.44 to $31.50…

    Published on 7/1/2015
  • TOP STORY: Hedge fund targets Exact Sciences' Cologuard

    CMS has placed Cologuard from Exact Sciences Corp. (NASDAQ:EXAS) on the agenda of a July 16 meeting to discuss 2016 payment levels for clinical tests. The action follows a campaign by hedge fund Cable Car Capital to …

    Published on 6/30/2015
  • TOP STORY: Celgene, Juno in 10-year pact

    Juno Therapeutics Inc. (NASDAQ:JUNO) gained $17.20 (37%) to $63.50 in after-hours trading after announcing a 10-year deal with Celgene Corp. (NASDAQ:CELG) to develop immunotherapies for cancer and autoimmune diseases, …

    Published on 6/29/2015
  • TOP STORY: Seres posts big gain after upsized IPO

    Seres Therapeutics Inc. (NASDAQ:MCRB) gained $33.40 (186%) to $51.40 after raising $133.7 million through the sale of 7.4 million shares at $18 in a bumped-up IPO underwritten by Goldman Sachs; BofA Merrill Lynch; …

    Published on 6/26/2015
  • TOP STORY: Biotechs flat following SCOTUS decision

    Biotech stocks were generally flat on Thursday after the U.S. Supreme Court rejected a challenge to the federal government's authority to provide subsidies to individuals who buy health insurance from the federal …

    Published on 6/25/2015
  • TOP STORY: China, Taiwan accept Ascletis' CTAs for HCV therapies

    Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said the China Food and Drug Administration (CFDA) and Taiwan Food and Drug Administration (TFDA) accepted clinical trial applications (CTAs) to run trials of …

    Published on 6/24/2015
  • TOP STORY: 21st Century Cures would extend exclusivity for 15% of drugs

    A six-month extension of marketing exclusivity proposed in the 21st Century Cures Act (H.R. 6) for drugs repurposed for Orphan indications would delay generic or biosimilar competition for about 15% of brand name drugs …

    Published on 6/23/2015
  • TOP STORY: ASCO publishes its value framework

    The American Society of Clinical Oncology published in the Journal of Clinical Oncology a framework designed to assess the value of cancer drugs. ASCO also published an assessment of drugs to treat four different tumor …

    Published on 6/22/2015
  • TOP STORY: PTAB to consider sanctions against Bass

    The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has accepted a request from Celgene Corp. (NASDAQ:CELG) to consider sanctions against the Coalition for Affordable Drugs, an entity controlled by…

    Published on 6/19/2015

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