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  • TOP STORY: Lawmakers introduce permanent Priority Review voucher bill

    Five U.S. Representatives introduced the Advancing Hope Act of 2015, a bill that would reauthorize and make permanent the Priority Review voucher incentive program for rare pediatric diseases. The bill's sponsors …

    Published on 3/23/2015
  • TOP STORY: Biogen climbs on early Alzheimer's data

    Biogen Idec Inc. (NASDAQ:BIIB) gained $42.33 (10%) to $475.98 on Friday after reporting detailed Phase Ib data for Alzheimer's disease (AD) candidate aducanumab (BIIB037).Aducanumab led to statistically significant …

    Published on 3/20/2015
  • TOP STORY: Researchers call for gene editing caution

    Advances in the use of the gene editing technology CRISPR for germline modifications have prompted a group of academic researchers and bioethicists to call for a conference of stakeholders to manage public concerns and …

    Published on 3/19/2015
  • TOP STORY: Stakeholders aiming to renew pediatric voucher program

    FDA issued its third Priority Review voucher under its pediatric disease voucher program Tuesday, which triggers a 12-month clock until the pilot program ends. The program is intended to give pharma companies incentives…

    Published on 3/18/2015
  • TOP STORY: Nektar misses in breast cancer

    Nektar Therapeutics (NASDAQ:NKTR) said etirinotecan pegol (NKTR-102) missed the primary endpoint of an improvement in median overall survival in the Phase III BEACON trial in metastatic breast cancer. Patients treated …

    Published on 3/17/2015
  • TOP STORY: PCSK9 inhibitors continue neck-and-neck

    In newly published analyses, the PCSK9 inhibitors Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) and Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed …

    Published on 3/16/2015
  • TOP STORY: FDA: Some breakthroughs faster than others

    As the queue of breakthrough designation candidates grows longer, FDA is setting standards for determining which of the applications will get the fastest reviews.In a new Manual of Policies and Procedures (MAPP) that …

    Published on 3/13/2015
  • TOP STORY: Epizyme jumps after buying back rights from Eisai

    Wall Street reversed course on Epizyme Inc. (NASDAQ:EPZM) on Thursday, driving the stock up $3.27 (15%) to $25.45 after initially selling shares on news the biotech is paying $40 million up front to Eisai Co. Ltd. (…

    Published on 3/12/2015
  • TOP STORY: Endo the road for Salix

    Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) gained $10.96 to $168.61 after Endo International plc (NASDAQ:ENDP; TSX:ENL) attempted to outbid Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) with a buyout …

    Published on 3/11/2015
  • TOP STORY: Janssen seeking to block Remicade biosimilar

    A suit filed by the Janssen Inc. unit of Johnson & Johnson (NYSE:JNJ) and by New York University against Celltrion Inc. (KOSDAQ:068270) and Hospira Inc. (NYSE:HSP) seeks to delay or block the U.S. launch of CT-P13, a …

    Published on 3/10/2015
  • TOP STORY: FDA panel backs Kythera's double-chin treatment

    FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted 17-0 to back approval of ATX-101 deoxycholic acid from Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH) to reduce submental (under chin) fat. The …

    Published on 3/9/2015
  • TOP STORY: FDA approves Zarxio, first biosimilar in U.S.

    FDA approved Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for the same indications as its reference product, Neupogen filgrastim methionyl human G-CSF from Amgen Inc. (NASDAQ:AMGN). …

    Published on 3/6/2015
  • TOP STORY: AbbVie investors lukewarm on Pharmacyclics deal

    AbbVie Inc. (NYSE:ABBV) shed $3.41 to $56.86 on news of its $21 billion acquisition of oncology play Pharmacyclics Inc. (NASDAQ:PCYC), a signal that shareholders are questioning whether the deal will fill AbbVie's …

    Published on 3/5/2015
  • TOP STORY: Quick FDA approval for Opdivo in NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) jumped $3.75 to $65.67 on Wednesday after FDA approved an sBLA for Opdivo nivolumab to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) who have progressed …

    Published on 3/4/2015
  • TOP STORY: Release of Contrave data validates FDA's demand for second trial

    Orexigen Therapeutics Inc. (NASDAQ:OREX) gained $1.85 (32%) to $7.64 after an interim analysis of the LIGHT cardiovascular (CV) outcomes study showed that the company's obesity drug Contrave naltrexone/bupropion may …

    Published on 3/3/2015
  • TOP STORY: Kyprolis superior to Velcade in second-line MM

    Amgen Inc. (NASDAQ:AMGN) said Kyprolis carfilzomib plus dexamethasone met the primary endpoint of superiority over Velcade bortezomib plus dexamethasone in a planned interim analysis of the Phase III ENDEAVOR trial in …

    Published on 3/2/2015
  • TOP STORY: FDA gets feedback on next-generation sequencing

    As FDA digests comments from last week's next-generation sequencing (NGS) workshop, Elizabeth Mansfield, the deputy office director for personalized medicine at the agency's Center for Devices and Radiological Health (…

    Published on 2/27/2015
  • TOP STORY: FDA approves Sanofi's Toujeo

    Sanofi (Euronext:SAN; NYSE:SNY) said FDA approved its Toujeo insulin glargine to improve glycemic control in adults with Type I and Type II diabetes. Sanofi expects to launch the drug and announce its price early next …

    Published on 2/26/2015
  • TOP STORY: FDA approves Avycaz for cUTIs and cIAI

    FDA approved an NDA for Avycaz ceftazidime/avibactam from Actavis plc (NYSE:ACT) to treat complicated urinary tract infections (cUTIs) and in combination with metronidazole to treat complicated intra-abdominal …

    Published on 2/25/2015
  • TOP STORY: Celltrion launches Remicade biosimilar in Europe

    Celltrion Inc. (KOSDAQ:068270) launched Remsima infliximab (CT-P13) in 12 European countries including Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the U.K. …

    Published on 2/24/2015
  • TOP STORY: FDA approves Novartis' Farydak for MM

    FDA granted accelerated approval to Farydak panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN) in combination with Velcade bortezomib and dexamethasone to treat multiple myeloma patients who have received at least two …

    Published on 2/23/2015
  • TOP STORY: Sanofi's pick checks boxes in emerging markets, established products

    Investors had a muted response to the appointment of Olivier Brandicourt as the new CEO at Sanofi (Euronext:SAN; NYSE:SNY), as the pharma's shares shed EUR 0.45 to EUR 87.39 on Euronext and were unchanged at $50.10 on …

    Published on 2/20/2015
  • TOP STORY: Sanofi names Brandicourt CEO

    Sanofi (Euronext:SAN; NYSE:SNY) named Olivier Brandicourt CEO effective April 2, choosing an outsider to replace ousted CEO Christopher Viehbacher. Brandicourt was most recently chairman of the board of management and …

    Published on 2/19/2015
  • TOP STORY: FDA to discuss oversight of next-generation sequencing

    FDA will hold a public workshop on Friday to discuss the agency's development of a regulatory framework for next-generation sequencing (NGS) tests.In a discussion draft, FDA said traditional regulatory approaches are …

    Published on 2/18/2015
  • TOP STORY: China FDA issues draft revisions to GCPs

    China FDA has issued long-awaited draft revisions to its Good Clinical Practices guidelines for pharmaceutical trials.The Chinese-language draft proposes changes to 34 GCP provisions, but should have few direct effects …

    Published on 2/17/2015

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