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  • TOP STORY: FDA panel backs NPS's Natpara for hypoparathyroidism

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8-5 to recommend approval of Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) to treat hypoparathyroidism. The PDUFA date is October 24.There …

    Published on 9/12/2014
  • TOP STORY: FDA panel backs liraglutide for obesity

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend approval of 3 mg liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) as an adjunct to diet and exercise in adults with a BMI of at …

    Published on 9/11/2014
  • TOP STORY: FDA approves Contrave; requires CV outcomes trial

    FDA approved Contrave naltrexone/bupropion from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with co-…

    Published on 9/10/2014
  • TOP STORY: Reviewers say liraglutide effective for obesity

    FDA reviewers said 3 mg liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) is effective as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with co-…

    Published on 9/9/2014
  • TOP STORY: Benralizumab continuing despite Phase IIa COPD miss

    A spokesperson for the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) told BioCentury the company started Phase III testing of benralizumab (MEDI-563) to treat chronic obstructive pulmonary disease even after…

    Published on 9/8/2014
  • TOP STORY: BMS, Ono challenge Merck in PD-1 patent suit

    Bristol-Myers Squibb Co. (NYSE:BMY) and Ono Pharmaceutical Co. Ltd. (Tokyo:4528) filed suit in the U.S. District Court for the District of Delaware alleging that Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) …

    Published on 9/5/2014
  • TOP STORY: FDA approves Merck's Keytruda

    FDA granted accelerated approval to Keytruda pembrolizumab (MK-3475) from Merck & Co. Inc. (NYSE:MRK) to treat advanced melanoma in patients previously treated with Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:…

    Published on 9/4/2014
  • TOP STORY: NICE backs Alexion's Soliris

    The U.K.'s NICE issued draft guidance recommending Orphan drug Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat atypical hemolytic uremic syndrome (aHUS), but the recommendation is contingent …

    Published on 9/3/2014
  • TOP STORY: Exelixis plummets on Cometriq miss

    Exelixis Inc. (NASDAQ:EXEL) fell $2.29 (55%) to $1.85 on Tuesday after top-line data showed its Cometriq cabozantinib missed the primary endpoint in the 960-patient Phase III COMET-1 trial to treat metastatic castration…

    Published on 9/2/2014
  • TOP STORY: Dezima CETP inhibitor meets endpoint in dyslipidemia trial

    Dezima Pharma B.V. (Naarden, the Netherlands) said TA-8995 (DEZ-001) alone or in combination with statin therapy met the primary endpoint vs. placebo in the 364-patient Phase IIb TULIP trial to treat dyslipidemia. The …

    Published on 8/29/2014
  • 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

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