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

Chronological Index of : Top Story

 Current Issue
  • TOP STORY: Amgen submits evolocumab BLA

    Amgen Inc. (NASDAQ:AMGN) submitted a BLA to FDA for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the U.S. …

    Published on 8/28/2014
  • TOP STORY: Arch closes $410 million fund

    Arch Venture Partners raised $410 million for its eighth fund, well above the firm's $250 million target for Arch Venture Fund VIII LP. The firm said it will invest the fund in early stage technologies in the healthcare…

    Published on 8/27/2014
  • TOP STORY: Zai raises over $30M in A round

    Zai Laboratory Inc. (Shanghai, China) raised more than $30 million in a series A round led by Qiming Venture Partners. Also participating were Kleiner Perkins Caufield & Byers; Sequoia Capital; TF Capital; and …

    Published on 8/26/2014
  • TOP STORY: Roche buying InterMune for $8.3B

    Roche (SIX:ROG; OTCQX:RHHBY) will acquire InterMune Inc. (NASDAQ:ITMN) for $74 per share, or about $8.3 billion in cash. The offer is a 63% premium to InterMune's $45.49 closing price on Aug. 12, before rumors …

    Published on 8/25/2014
  • TOP STORY: EMA to review Cubist's ceftolozane/tazobactam

    EMA accepted for review an MAA for ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). A …

    Published on 8/22/2014
  • TOP STORY: Illumina, pharmas partner for universal cancer assay

    Illumina Inc. (NASDAQ:ILMN) partnered with three pharmas to develop a next-generation sequencing-based system to detect genetic variants linked to cancer that can be used to match patients with targeted therapeutics. …

    Published on 8/21/2014
  • TOP STORY: Amicus gains after Amigal meets in Phase III

    Amicus Therapeutics Inc. (NASDAQ:FOLD) rose $0.93 (20%) to $5.50 on Wednesday after reporting that Amigal migalastat (AT1001) met the co-primary endpoints of comparability to enzyme replacement therapy (ERT) on two …

    Published on 8/20/2014
  • TOP STORY: Ceftazidime/avibactam meets in cIAI trials

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Actavis plc (NYSE:ACT) said IV ceftazidime/avibactam (CAZ-104) plus metronidazole met the EMA- and FDA-defined primary endpoints of non-inferiority to meropenem in pooled data …

    Published on 8/19/2014
  • TOP STORY: NICE upholds Ferring appeal on Firmagon

    The U.K.'s NICE will reconsider an April final appraisal determination (FAD) for Firmagon degarelix from Ferring Pharmaceuticals A/S (Saint-Prex, Switzerland) after an agency panel upheld an appeal by the company. The …

    Published on 8/18/2014
  • TOP STORY: Achillion gains on HCV data

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) was up $0.81 (10%) to $9.25 on Friday after reporting interim data from a Phase II study of HCV compound ACH-3102. All 12 treatment-naïve patients with genotype 1 …

    Published on 8/15/2014
  • 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

< 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