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  • TOP STORY: Senators propose new antibiotics pathway

    U.S. Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act to create a new approval pathway for antibiotics.The bill, which will need to be…

    Published on 12/11/2014
  • TOP STORY: GPhA, BIO compromise on interchangeability

    The Generic Pharmaceutical Association (GPhA) and the Biotechnology Industry Organization (BIO) have agreed to introduce the same proposal to state legislatures next year concerning the substitution of interchangeable …

    Published on 12/10/2014
  • TOP STORY: bluebird jumps 72% on interim LentiGlobin data

    bluebird bio Inc. (NASDAQ:BLUE) gained $35.39 (72%) to $84.28 on Tuesday, giving it a market cap of $2.4 billion, after it presented interim data from two Phase I/II trials of its LentiGlobin BB305 gene therapy at the …

    Published on 12/9/2014
  • TOP STORY: Cubist: Court ruling won't upend Merck takeout

    Shares of Cubist Pharmaceuticals Inc. (NASDAQ:CBST) receded slightly in after-hours trading on Monday after surging $26.24 (35%) to $100.60 on news Merck & Co. Inc. (NYSE:MRK) will acquire the biotech for $9.5 billion, …

    Published on 12/8/2014
  • TOP STORY: Merck reportedly eyeing Cubist

    Cubist Pharmaceuticals Inc. (NASDAQ:CBST) surged $16.89 (23%) to $91.25 in after-hours trading Friday on rumors the infectious disease play is in talks to be acquired by Merck & Co. Inc. (NYSE:MRK). According to an …

    Published on 12/5/2014
  • TOP STORY: FDA outlines path to obtain reference drugs under REMS

    FDA released draft guidance designed to help generics companies obtain reference drugs for bioequivalence (BE) studies when those drugs are subject to REMS and are not available through regular distribution channels.The…

    Published on 12/4/2014
  • TOP STORY: Array windfall from Novartis-GSK deal

    Array BioPharma Inc. (NASDAQ:ARRY) gained $0.89 (23%) to $4.80 in after-hours trading on Wednesday after Novartis AG (NYSE:NVS; SIX:NOVN) returned rights to oncology candidate binimetinib in the aftermath of the pharma'…

    Published on 12/3/2014
  • TOP STORY: Otsuka buying Avanir for $3.5B

    Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) will acquire Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) for $3.5 billion, or $17 per share. The price represents a 13% premium to Avanir's closing price of $15 on Dec. 1 …

    Published on 12/2/2014
  • TOP STORY: NICE backs Soliris without lifting veil

    The U.K.'s NICE issued a final evaluation determination recommending Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat atypical hemolytic uremic syndrome (aHUS) without receiving the specific …

    Published on 12/1/2014
  • TOP STORY: uniQure partner prices gene therapy Glybera at EUR 1.1M

    Chiesi Farmaceutici S.p.A (Parma, Italy) has filed a pricing dossier for Glybera alipogene tiparvovec with Germany's Federal Joint Committee (G-BA) that pegs the price of the gene therapy at over EUR 1 million. Chiesi …

    Published on 11/26/2014
  • TOP STORY: Cell Medica raises L50M series B

    Cell therapy developer Cell Medica Ltd. (London, U.K.) raised L50 million ($78.2 million) in a series B round led by Imperial Innovations. Invesco Perpetual and Woodford Investment Management also participated.Cell …

    Published on 11/25/2014
  • TOP STORY: BioMarin to acquire Prosensa

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) has concluded it can successfully make the case to gain approval for drisapersen to treat Duchenne muscular dystrophy after it acquires Prosensa Holding N.V. (NASDAQ:RNA) for $…

    Published on 11/24/2014
  • TOP STORY: Rep. Upton updates 21st Century Cures timeline

    Rep. Fred Upton (R-Mich.) said he plans to release a discussion draft in mid-January 2015 of legislation based on the 21st Century Cures initiative he and Rep. Diana DeGette (D-Colo.) launched in May.Speaking at a …

    Published on 11/21/2014
  • TOP STORY: Clovis reports interim Phase II in PARP race

    Clovis Oncology Inc. (NASDAQ:CLVS) reported initial data from the Phase II ARIEL2 trial of rucaparib (CO-338) to treat platinum-sensitive, relapsed ovarian cancer. The biotech suggested combining tumor BRCA1/2 mutation …

    Published on 11/20/2014
  • TOP STORY: CF Foundation sells royalty rights for $3.3B

    Royalty Pharma (New York, N.Y.) paid $3.3 billion to acquire the Cystic Fibrosis Foundation's rights to royalties from cystic fibrosis (CF) treatments developed by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). The deal …

    Published on 11/19/2014
  • TOP STORY: CRISPR newco Intellia gets $15M from Atlas, Novartis

    Intellia Therapeutics Inc. (Cambridge, Mass.) closed a $15 million series A round from Atlas Venture and Novartis AG (NYSE:NVS; SIX:NOVN) to develop therapeutics using CRISPR-Cas9 technology.Intellia is developing ex …

    Published on 11/18/2014
  • TOP STORY: Juno files for IPO

    Less than a year after Juno Therapeutics Inc. (Seattle, Wash.) debuted with a massive series A round, the cancer immunotherapy play is looking to go public. The company on Monday filed to raise up to $150 million in an …

    Published on 11/17/2014
  • TOP STORY: EU tribunal annuls 2011 election of EMA director Rasi

    The European Union Civil Service Tribunal annulled EMA's 2011 appointment of Guido Rasi as its executive director based on an appeal of a procedural matter leading to his appointment. Deputy Executive Director Andreas …

    Published on 11/14/2014
  • TOP STORY: AstraZeneca, Isis team up on antisense delivery

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Isis Pharmaceuticals Inc. (NASDAQ:ISIS) partnered to develop new targeted delivery methods for antisense oligonucleotides with a focus on cancer and cardiovascular and metabolic …

    Published on 11/13/2014
  • TOP STORY: Intarcia licenses ITCA 650 to Servier ex-U.S., Japan

    Intarcia Therapeutics Inc. (Boston, Mass.) has granted Servier (Neuilly-sur-Seine, France) exclusive development and commercialization rights to implantable diabetes therapy ITCA 650 outside the U.S. and Japan.Intarcia …

    Published on 11/12/2014
  • TOP STORY: Brodalumab tops Stelara in Phase III psoriasis trial

    Amgen Inc. (NASDAQ:AMGN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said brodalumab showed superiority to Stelara ustekinumab from Johnson & Johnson (NYSE:JNJ) and placebo in the head-to-head Phase III AMAGINE-3 trial to …

    Published on 11/11/2014
  • TOP STORY: China launches its biosimilars process

    The China Food and Drug Administration has issued draft guidance that lays down principles for developing biosimilars of biologics already approved in China, including products intended to be extrapolated to multiple …

    Published on 11/10/2014
  • TOP STORY: FLINTy reception for Intercept

    Although a Bloomberg report on The Lancet's publication of data from the Phase II FLINT trial of obeticholic acid in non-alcoholic steatohepatitis (NASH) largely rehashed old ground, investors hammered shares of …

    Published on 11/7/2014
  • TOP STORY: Salix hit on accounting turmoil

    Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) plunged $53.05 (38%) to $85.50 in after-hours trading on Thursday on news its CFO had resigned and the company had retained outside counsel to investigate how it was accounting …

    Published on 11/6/2014
  • TOP STORY: MMRF, FDA, NCI to develop multiple myeloma master protocol

    The Multiple Myeloma Research Foundation (MMRF) announced plans to develop a multiple myeloma (MM) "master protocol" in partnership with FDA, the National Cancer Institute (NCI), industry and academic leaders, and …

    Published on 11/5/2014

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