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  • TOP STORY: CHMP recommends Gilead's HCV combo

    EMA's CHMP recommended marketing authorization for Harvoni sofosbuvir/ledipasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV infection in adults. Gilead expects a final decision from the European …

    Published on 9/26/2014
  • TOP STORY: Nicox gains on Phase III glaucoma data

    Nicox S.A. (Euronext:COX) gained EUR 0.46 (21%) to EUR 2.62 on Thursday after it said Vesneo latanoprostene bunod (formerly NCX 116, BOL-303259-X) met its primary endpoint of non-inferiority vs. timolol maleate in two …

    Published on 9/25/2014
  • TOP STORY: Acorda buying Civitas for $525M

    Neurological disorder company Acorda Therapeutics Inc. (NASDAQ:ACOR) surged $8.27 (28%) to $37.62 on Wednesday on news it will acquire Civitas Therapeutics Inc. (Chelsea, Mass.) for $525 million in cash. The main driver…

    Published on 9/24/2014
  • TOP STORY: Molecular Partners files for IPO

    Ophthalmic and cancer company Molecular Partners AG (Schlieren, Switzerland) said it is planning to raise CHF125 million ($133.1 million) in an IPO on the SIX Swiss Exchange in 4Q14. Molecular's lead compound is …

    Published on 9/23/2014
  • TOP STORY: Merck buying Sigma-Aldrich for $17B

    Merck KGaA (Xetra:MRK) will acquire Sigma-Aldrich Corp. (NASDAQ:SIAL) for about $17 billion in cash. Merck will pay $140 per share, a 37% premium to Sigma-Aldrich's Friday close of $102.37, before the news was announced…

    Published on 9/22/2014
  • TOP STORY: GSK apologizes after huge fine in China

    A Chinese court has fined the GSK China Investment Co. Ltd. subsidiary of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and found it guilty of bribing "non-government personnel" and violating Chinese law by offering money or …

    Published on 9/19/2014
  • TOP STORY: ProQR raises $97.5M in bumped up IPO

    ProQR Therapeutics N.V. (NASDAQ:PRQR) jumped $1.73 (13%) to $14.73 in its first day of trading Thursday after raising $97.5 million through the sale of 7.5 million shares at $13 in an IPO. The IPO price valued the …

    Published on 9/18/2014
  • TOP STORY: Tokai raises $92.7M in upsized IPO

    Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) was up $8.76 (58%) to $23.76 on its first day of trading Wednesday after raising $97.2 million through the sale of 6.5 million shares at $15 in an IPO. The IPO price valued the …

    Published on 9/17/2014
  • TOP STORY: Takeda announces global reorganization

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) announced the reorganization of its commercial and R&D operations -- its first major organizational move since naming Christophe Weber as COO effective April 2014 and …

    Published on 9/16/2014
  • TOP STORY: Avanir surges on AD agitation data

    Investors added $1 billion in market cap to Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) on Monday after the company's AVP-923 dextromethorphan/quinidine met the primary endpoint vs. placebo of reducing agitation in a …

    Published on 9/15/2014
  • 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

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