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  • 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
  • TOP STORY: Eisai's lenvatinib latest of FDA's quick approvals

    FDA approved Lenvima lenvatinib (E7080) from Eisai Co. Ltd. (Tokyo:4523) to treat progressive, radioiodine-refractory differentiated thyroid cancer. The approval comes well ahead of the drug's April 14 PDUFA date, …

    Published on 2/13/2015
  • TOP STORY: J&J forms groups to tackle prevention, microbiome

    Johnson & Johnson (NYSE:JNJ) announced on Thursday the creation of three new dedicated groups to concentrate its R&D work in disease interception, disease prevention and microbiome research. Each of the new groups will …

    Published on 2/12/2015
  • TOP STORY: Genzyme, Voyager in CNS gene therapy tie-up

    Voyager Therapeutics Inc. (Cambridge, Mass.) and the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) partnered to develop and commercialize Voyager's gene therapies for CNS diseases.The deal gives Genzyme options …

    Published on 2/11/2015
  • TOP STORY: Hospira, Pfenex in deal for Lucentis biosimilar

    Pfenex Inc. (NYSE-M:PFNX) jumped $1.10 (16%) to $8 on Tuesday after partnering with Hospira Inc. (NYSE:HSP) to collaborate on the development of PF-582, Pfenex's biosimilar of Lucentis ranibizumab from the Genentech Inc…

    Published on 2/10/2015
  • TOP STORY: Achillion climbs on ACH-3102 data

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) gained $0.84 to $11.66 on Monday after it said 100% of HCV genotype 1 patients receiving ACH-3102 plus Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) achieved an …

    Published on 2/9/2015

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