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  • TOP STORY: NICE provisionally recommends Sovaldi

    The U.K.'s NICE provisionally recommended Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) for chronic HCV infection in its second draft guidance issued on Thursday. The committee recommended Sovaldi in …

    Published on 8/14/2014
  • TOP STORY: FDA approves Merck's suvorexant

    FDA approved Belsomra suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. The pharma said it plans to make the dual orexin receptor antagonist available in the U.S. by late 2014 or early 2015. The launch is …

    Published on 8/13/2014
  • TOP STORY: Intercept surges on lipid data

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) jumped $39.34 (17%) to $276.52 on Tuesday after reporting additional data late Monday from the Phase II FLINT trial of obeticholic acid in non-alcoholic steatohepatitis (NASH…

    Published on 8/12/2014
  • TOP STORY: Celltrion submits first biosimilar mAb application to FDA

    Celltrion Inc. (KOSDAQ:068270) submitted an application to FDA for Remsima infliximab, a biosimilar of Remicade from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). The application is the first biosimilar …

    Published on 8/11/2014
  • TOP STORY: VBL will not issue IPO shares

    Vascular Biogenics Ltd. (dba VBL Therapeutics Ltd.) said its underwriters -- Deutsche Bank; Wells Fargo; JMP Securities; Needham; and Oppenheimer -- terminated the underwriting agreement for the company's IPO after a "…

    Published on 8/8/2014
  • TOP STORY: FDA converts full hold on TKM-Ebola to partial hold

    Tekmira Pharmaceuticals Corp. (TSX:TKM; NASDAQ:TKMR) announced after market close on Thursday that FDA converted the full clinical hold it had placed on a Phase I trial of the company's TKM-Ebola to a partial hold. The …

    Published on 8/7/2014
  • TOP STORY: FDA approves Orbactiv

    FDA approved an NDA from The Medicines Co. (NASDAQ:MDCO) for Orbactiv oritavancin to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by Gram-positive bacteria, including methicillin-resistant …

    Published on 8/6/2014
  • TOP STORY: Juno raises $134 million in B round

    Cancer immunotherapy company Juno Therapeutics Inc. (Seattle, Wash.) raised $134 million in a series B round from 10 undisclosed, new public mutual funds and healthcare-focused funds. The company said all of its "major…

    Published on 8/5/2014
  • TOP STORY: Insmed plummets on Arikayce update

    Insmed Inc. (NASDAQ:INSM) fell $4.59 (27%) to $12.66 on Monday after announcing it would need to conduct an additional Phase III trial of Arikayce amikacin to treat non-tuberculous mycobacterial (NTM) lung infection …

    Published on 8/4/2014
  • TOP STORY: L300M in new investments for Genomics England

    U.K. Prime Minister David Cameron announced over L300 million ($509.4 million) in new investments for Genomics England Ltd. (London, U.K.), which is sequencing and analyzing the genomes of 100,000 NHS patients by 2017. …

    Published on 8/1/2014
  • TOP STORY: FDA proposes risk-based LDT regulation

    FDA released pre-draft guidance on Thursday proposing a risk-based framework for regulating laboratory-developed diagnostic tests (LDTs). Under the proposed scheme, FDA would classify LDTs as low-, moderate- or high-…

    Published on 7/31/2014
  • TOP STORY: AZ to acquire Almirall's respiratory business

    AstraZeneca plc (LSE:AZN; NYSE:AZN) will acquire the respiratory disease business of Almirall S.A. (Madrid:ALM) for $875 million up front and up to $1.2 billion in milestones. The business had 1H14 sales of EUR 123.5 …

    Published on 7/30/2014
  • TOP STORY: Amgen cutting up to 15% of workforce

    Amgen Inc. (NASDAQ:AMGN) reported 2Q14 financial results Tuesday that beat the Street but the bellwether also unveiled plans to reduce headcount by about 12-15%, or 2,400-2,900, companywide through 2015. Amgen plans to …

    Published on 7/29/2014
  • TOP STORY: Full FDA approval for Imbruvica in CLL

    FDA granted full approval to Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and Johnson & Johnson (NYSE:JNJ) as first-line therapy for chronic lymphocytic leukemia (CLL) in patients with 17p deletion and to …

    Published on 7/28/2014
  • TOP STORY: CHMP backs Zydelig, Imbruvica

    EMA's CHMP issued positive opinions for several drugs on Friday, including Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) and Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & …

    Published on 7/25/2014
  • TOP STORY: FDA accepts Sandoz's BLA for filgrastim biosimilar

    Sandoz, a unit of Novartis AG (NYSE:NVS; SIX:NOVN), said FDA accepted a BLA for a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). Sandoz is the first company to announce FDA's acceptance …

    Published on 7/24/2014
  • TOP STORY: Sovaldi sales hit $3.5 billion in 2Q14

    Gilead Sciences Inc. (NASDAQ:GILD) reported 2Q14 financial results that beat the Street, including $3.5 billion in sales of HCV drug Sovaldi sofosbuvir. The Street was expecting $2.5-$2.6 billion in Sovaldi sales in the…

    Published on 7/23/2014
  • TOP STORY: Appeals courts issue conflicting ACA rulings

    Two appeals courts issued conflicting rulings on whether enrollees on the Affordable Care Act's federal health exchanges are eligible for subsidies -- an issue central to the law's implementation. On Tuesday, the U.S. …

    Published on 7/22/2014
  • TOP STORY: Cerecor raises $15 million in B round

    Cerecor Inc. (Baltimore, Md.) raised $15 million in the first tranche of a planned $32 million series B round. New investors New Enterprise Associates; Apple Tree Partners; and MPM Capital led the tranche. Cerecor's …

    Published on 7/21/2014
  • TOP STORY: AbbVie to acquire Shire

    AbbVie Inc. (NYSE:ABBV) will acquire Shire plc (LSE:SHP; NASDAQ:SHPG) for about L31.4 billion ($53.8 billion) in cash and stock. The offer comprises L24.44 in cash and 0.8960 AbbVie shares per Shire share. Shire …

    Published on 7/18/2014
  • TOP STORY: GSK stops melanoma trial early on interim data

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said an interim analysis by an independent DMC showed Tafinlar dabrafenib plus Mekinist trametinib met a prespecified threshold of improving overall survival (OS), the primary …

    Published on 7/17/2014
  • TOP STORY: Crenezumab misses in AD Phase IIs

    Crenezumab from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) missed the primary and secondary endpoints in two Phase II trials to treat Alzheimer's disease. Genentech said it is "premature" to discuss development …

    Published on 7/16/2014
  • TOP STORY: Yellen says biotech valuations 'substantially stretched'

    Healthcare indices posted sharper declines than the broader markets Tuesday after Federal Reserve Chairperson Janet Yellen said valuations for smaller biotech firms "appear substantially stretched" despite a correction …

    Published on 7/15/2014
  • TOP STORY: Shire 'willing to recommend' upped AbbVie bid

    Shire plc (LSE:SHP; NASDAQ:SHPG) said its board would be "willing to recommend" an increased bid from AbbVie Inc. (NYSE:ABBV) to acquire the company. The new bid values Shire at L31.8 billion ($54.5 billion) in cash and…

    Published on 7/14/2014
  • TOP STORY: Senators push for details on Sovaldi's cost

    Two members of the Senate Finance Committee requested pricing information for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), including an explanation of the difference between the drug's current …

    Published on 7/11/2014

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