Skip to main content
Home > The Daily Extra > Top Story

Chronological Index of : Top Story

 Current Issue
  • TOP STORY: Biotech stocks down amid more bad news

    Biotech indices posted steep losses on Tuesday, wiping out most of the gains from a short rally late last week and prolonging an extended slump for the sector.Decliners outnumbered gainers by 90 to 10 among BioCentury …

    Published on 10/6/2015
  • TOP STORY: TPP provides 5-plus years of biologics exclusivity

    The Trans-Pacific Partnership trade treaty will set a floor of five years of data protection for biologics, U.S. Trade Representative Michael Froman announced Monday. Details of the agreement have not been released. …

    Published on 10/5/2015
  • TOP STORY: Amicus plummets on NDA delay

    Amicus Therapeutics Inc. (NASDAQ:FOLD) shed $7.36 (53%) to $6.39 on Friday, losing all of its 2015 gains, after the company said it no longer planned to submit an NDA to FDA by YE15 for Amigal migalastat to treat Fabry'…

    Published on 10/2/2015
  • TOP STORY: Sarepta rises on long-term Phase IIb DMD data

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) jumped $7.17 (22%) to $39.28 on Thursday after reporting long-term follow-up data from Phase IIb trials of eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) …

    Published on 10/1/2015
  • TOP STORY: Biotech stocks end skid on last day of 3Q15

    Biotech indices rose Wednesday, ending an eight-day run of losses. The BioCentury 100 index gained 246.89 (4.4%) to 5,815.33. The index lost 23% during 3Q15, and is down 3.1% for the year.The NASDAQ Biotechnology Index…

    Published on 9/30/2015
  • TOP STORY: Losing streak continues for biotech stocks

    Biotech indices failed to hold intraday gains on Tuesday, losing ground for the eighth consecutive day in a sell-off that has pushed the indices into the red for the year (see BioCentury Extra, Sept. 28).The BioCentury …

    Published on 9/29/2015
  • TOP STORY: Biotech stocks give back 2015's gains

    Biotech stock indices tumbled again on Monday, and now are in the red for the year.The BioCentury 100 Index shed 405.61 (7%) to 5,671.92 on Monday. The index is down 31% since its July 20 peak of 8,161.20. For the year,…

    Published on 9/28/2015
  • TOP STORY: Biotech stocks still reeling

    Biotech stocks continued a week-long slide Friday, as indices ended the week with double-digit losses from their Sept. 18 close. The BioCentury 100 Index sank 353.51 (5.5%) to 6077.54 on Friday and finished the week …

    Published on 9/25/2015
  • TOP STORY: Novartis' NIBR taps Bradner to replace Fishman

    Novartis AG (NYSE:NVS; SIX:NOVN) named James Bradner president of the Novartis Institutes for BioMedical Research (NIBR) and a member of Novartis' executive committee.He replaces Mark Fishman, who will retire in March …

    Published on 9/24/2015
  • TOP STORY: PhRMA close to picking Ubl as CEO

    The Pharmaceutical Research and Manufacturers of America has tentatively selected Stephen Ubl as its new president and CEO, according to a board member. PhRMA spokesperson Robert Zirkelbach told BioCentury no decision …

    Published on 9/23/2015
  • TOP STORY: Biotech stocks continue down on Clinton drug plan

    Biotech stocks continued their tumble today after Hillary Clinton released her proposal to lower prescription drug costs. Biotech indices began falling yesterday in response to calls from Clinton and Sen. Bernie Sanders…

    Published on 9/22/2015
  • TOP STORY: Biotech stocks sink as Clinton, Sanders jump on Turing

    On Monday, Hillary Clinton wrote on Twitter that she will release a plan Tuesday to address "price gouging" on specialty drugs, which she called "outrageous," and referred to a New York Times story that said Turing …

    Published on 9/21/2015
  • TOP STORY: IPR tweak proposed

    Staff working for Sen. Chuck Grassley (R-Iowa), chairman of the U.S. Senate Judiciary Committee, have drafted a legislative proposal intended to address one of the drug industry's complaints about the inter partes …

    Published on 9/18/2015
  • TOP STORY: Lilly gains on Jardiance CVOT data

    Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY) reported data from the EMPA-REG OUTCOME cardiovascular outcomes trial (CVOT) of Jardiance empagliflozine plus standard of care (SOC), which…

    Published on 9/17/2015
  • TOP STORY: Phase III schizophrenia data lift Intra-Cellular to record high

    Intra-Cellular Therapies Inc. (NASDAQ:ITCI) climbed $22.68 (87%) to an all-time high close of $48.79 on Wednesday after the 60 mg dose of ITI-007 met the primary endpoint in a Phase III trial to treat schizophrenia. …

    Published on 9/16/2015
  • TOP STORY: Obama nominates Califf as FDA commissioner

    The White House said Tuesday that President Obama will nominate Robert Califf as FDA commissioner. Califf has served as FDA deputy commissioner for medical products and tobacco since March.If confirmed by the Senate, he…

    Published on 9/15/2015
  • TOP STORY: Raptor sinks on Phase IIb pediatric NASH miss

    Raptor Pharmaceutical Corp. (NASDAQ:RPTP) fell $4.51 (37%) to $7.52 after RP103 missed its primary endpoint in the Phase IIb CyNCh trial to treat nonalcoholic steatohepatitis (NASH) in children ages 8-17. Raptor does …

    Published on 9/14/2015
  • TOP STORY: ICER values Entresto 17% below list price

    The Institute for Clinical and Economic Review (ICER) released a value assessment report for congestive heart failure (CHF) therapy Entresto sacubitril/valsartan from Novartis AG (NYSE:NVS; SIX:NOVN). The non-profit …

    Published on 9/11/2015
  • TOP STORY: ZS Pharma in talks with Actelion

    ZS Pharma Inc. (NASDAQ:ZSPH) confirmed in a statement after market close that it has "participated in preliminary discussions" with Actelion Ltd. (SIX:ATLN) about a "potential strategic transaction." ZS gained $16.54 (…

    Published on 9/10/2015
  • TOP STORY: AstraZeneca's AZD9291 data lead to Clovis bump

    Clovis Oncology Inc. (NASDAQ:CLVS) gained $11.67 (14%) to $96.05 on Wednesday after AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data for a competing program in non-small cell lung cancer (NSCLC) that analysts said …

    Published on 9/9/2015
  • TOP STORY: ICER publishes PCSK9 assessment

    The Institute for Clinical and Economic Review (ICER) published an assessment of PCSK9 inhibitors Repatha evolocumab and Praluent alirocumab that concluded the annual value-based price for each of the two drugs should …

    Published on 9/8/2015
  • TOP STORY: Cancer Drugs Fund de-lists additional therapies

    NHS England dropped or restricted coverage of 17 additional drugs covering 25 indications from its list of therapies covered by the Cancer Drugs Fund (CDF). Eight drugs were cut altogether, while nine had the number of …

    Published on 9/4/2015
  • TOP STORY: Sandoz launches Zarxio at 15% discount to Neupogen

    The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) launched Zarxio filgrastim-sndz in the U.S. at a 15% discount to its reference drug, Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). Zarxio is the first …

    Published on 9/3/2015
  • TOP STORY: CAFC ruling clears path for Zarxio launch

    The U.S. Court of Appeals for the Federal Circuit denied an attempt by Amgen Inc. (NASDAQ:AMGN) to further delay the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN). The denial …

    Published on 9/2/2015
  • TOP STORY: BIO says IPR exemption won't increase Medicare costs

    The Biotechnology Industry Organization believes that a Congressional Budget Office estimate of the cost of proposed patent reforms is based on faulty assumptions, BIO General Counsel Tom DiLenge told BioCentury.The CBO…

    Published on 9/1/2015

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993