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  • TOP STORY: Biogen to spin off hemophilia business

    Biogen Inc. (NASDAQ:BIIB) said it plans to spin off its hemophilia business into a separate public company by early 2017. It intends to distribute shares in the still-unnamed company to Biogen stockholders.The newco …

    Published on 5/3/2016
  • TOP STORY: Regeneron's anti-NGF mAb meets Phase II/III endpoint

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said fasinumab (REGN475) met the primary endpoint of significantly improving pain relief vs. placebo in a Phase II/III study to treat moderate to severe osteoarthritis (OA) …

    Published on 5/2/2016
  • TOP STORY: Medivation rejects Sanofi bid

    To little surprise, Medivation Inc. (NASDAQ:MDVN) rejected an unsolicited bid from Sanofi (Euronext:SAN; NYSE:SNY) to acquire the company for $52.50 per share in cash, or about $9.3 billion. Sanofi made its offer public…

    Published on 4/29/2016
  • TOP STORY: AbbVie acquiring Stemcentrx

    AbbVie Inc. (NYSE:ABBV) will acquire Stemcentrx Inc. (South San Francisco, Calif.) for about $5.8 billion in upfront cash and stock. The deal gives AbbVie Rova-T rovalpituzumab tesirine, which is in the registrational …

    Published on 4/28/2016
  • TOP STORY: Lawmakers preparing response to CMS Part B changes

    Republicans in the House and Senate plan to send letters this week to Andy Slavitt, acting CMS administrator, urging him to withdraw proposed changes to reimbursement for drugs administered under Medicare Part B. …

    Published on 4/27/2016
  • TOP STORY: The Column Group closes third fund

    The Column Group closed its third fund at $535 million, founder and Managing Partner Peter Svennilson disclosed to BioCentury. He said the firm intends to invest the new fund in about eight companies. TCG closed its …

    Published on 4/26/2016
  • TOP STORY: FDA panel doubts Sarepta has shown eteplirsen's efficacy

    Members of FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 7-3 with three abstentions that clinical results provided by Sarepta Therapeutics Inc. (NASDAQ:SRPT) did not provide substantial …

    Published on 4/25/2016
  • TOP STORY: FDA asks Sarepta panel for efficacy vote

    FDA will ask an advisory committee to vote on five questions at an April 25 meeting to discuss an NDA from Sarepta Therapeutics Inc. (NASDAQ:SRPT) for eteplirsen (AVI-4658). On Friday, FDA added the questions to …

    Published on 4/22/2016
  • TOP STORY: Sarepta hammered after FDA outlines eteplirsen concerns

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) sank $8.69 (44%) to $11.02 on Monday after FDA released a second set of briefing documents expressing concerns about the company's data package for eteplirsen (AVI-4658) to treat …

    Published on 4/21/2016
  • TOP STORY: First clinical data for BioMarin hemo A gene therapy

    At its R&D day on Wednesday, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reported preliminary data from the first eight patients with severe hemophilia A who received a single dose of IV BMN 270 in an ongoing dose-…

    Published on 4/20/2016
  • TOP STORY: J&J raises guidance, hits all-time high

    Johnson & Johnson (NYSE:JNJ) gained $1.75 to $112.68 on Tuesday, touching an all-time intraday high of $113.95, after it reported 1Q16 earnings and raised its 2016 sales guidance to $71.2-$71.9 billion from $70.8-$71.5 …

    Published on 4/19/2016
  • TOP STORY: Illumina cuts growth forecast after soft 1Q16

    Illumina Inc. (NASDAQ:ILMN) shed $32.93 (18%) to $145.20 in after-hours trading Monday after the company reported preliminary 1Q16 revenues of $572 million, shy of analysts' $596.3 million consensus estimate. The …

    Published on 4/18/2016
  • TOP STORY: Illumina launches new VC firm with $100M

    Illumina Inc. (NASDAQ:ILMN) is investing $100 million in the first fund of Illumina Ventures, a new independently managed venture firm. Former Illumina SVP of Corporate and Venture Development Nicholas Naclerio is the …

    Published on 4/15/2016
  • TOP STORY: IMS: Drug spending growth slows in 2015

    The IMS Institute for Healthcare Informatics said U.S. drug spending grew 8.5% to $309.5 billion on a net price basis in 2015, according to a report published Thursday. On a conference call, Executive Director Murray …

    Published on 4/14/2016
  • TOP STORY: Parker Foundation launches cancer institute with $250M

    Entrepreneur Sean Parker's The Parker Foundation established a cancer immunotherapy institute to bring together six academic research centers, and granted the institute $250 million.The newly launched Parker Institute …

    Published on 4/13/2016
  • TOP STORY: FDA panel: Delay decision on Clovis' rociletinib

    FDA's Oncologic Drugs Advisory Committee voted 12-1 on Tuesday that FDA should await the outcome of the confirmatory Phase III TIGER-3 trial of rociletinib (CO-1686) from Clovis Oncology Inc. (NASDAQ:CLVS) before the …

    Published on 4/12/2016
  • TOP STORY: Intellia partners with Regeneron, files for IPO

    Intellia Therapeutics Inc. (Cambridge, Mass.) filed for an IPO and granted Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) exclusive rights to use its CRISPR-Cas9 (CRISPR-associated protein 9) technology against up to 10 …

    Published on 4/11/2016
  • TOP STORY: Clovis sinks as rociletinib questions linger

    Clovis Oncology Inc. (NASDAQ:CLVS) lost $3.40 (18%) to $15.77 on Friday after FDA reviewers asked an advisory committee whether the company will need to submit more data before the agency decides whether to approve lung…

    Published on 4/8/2016
  • TOP STORY: FDA panel unanimously backs Intercept's Ocaliva

    Members of FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted 17-0 that there is substantial evidence to support accelerated approval of Ocaliva obeticholic acid (OCA) from Intercept Pharmaceuticals Inc. (…

    Published on 4/7/2016
  • TOP STORY: Allergan in AD deal after calling off Pfizer merger

    Less than a day after Allergan plc (NYSE:AGN) and Pfizer Inc. (NYSE:PFE) called off their proposed merger, Allergan obtained rights to a portfolio of muscarinic agonists from the Heptares Therapeutics Ltd. subsidiary of…

    Published on 4/6/2016
  • TOP STORY: FDA reviewers mull surrogate endpoint for Intercept's OCA

    FDA reviewers questioned the utility of alkaline phosphatase (ALP) as a surrogate endpoint for approval of obeticholic acid (OCA; DSP-1747) from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) to treat primary biliary …

    Published on 4/5/2016
  • TOP STORY: Gilead acquiring Nimbus' NASH subsidiary

    Gilead Sciences Inc. (NASDAQ:GILD) is acquiring the Nimbus Apollo Inc. subsidiary of Nimbus Therapeutics LLC (Cambridge, Mass.) for $400 million up front and up to $800 million in development milestones. The deal gives …

    Published on 4/4/2016
  • TOP STORY: Dupilumab hits marks in Phase III dermatitis trials

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said dupilumab (REGN668) met the primary endpoint in two identical Phase III trials to treat moderate to severe atopic dermatitis.…

    Published on 4/1/2016
  • TOP STORY: GSK relaxing IP approach in poorer countries

    On a conference call Thursday, CEO Andrew Witty said GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is taking steps to align its patent filing and enforcement policies with various nations' levels of "economic maturity." Witty…

    Published on 3/31/2016
  • TOP STORY: Califf says staffing is top priority

    In a blog post Wednesday, new FDA Commissioner Robert Califf said improvements to the hiring system and retention of FDA staff were top priorities."I will pursue a workforce initiative designed to improve the hiring …

    Published on 3/30/2016

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