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  • TOP STORY: Merck settles PD-1 dispute with BMS, Ono

    Merck & Co. Inc. (NYSE:MRK) entered a settlement and license agreement with Bristol-Myers Squibb Co. (NYSE:BMY) and partner Ono Pharmaceutical Co. Ltd. (Tokyo:4528) that will end all litigation pertaining to Keytruda …

    Published on 1/20/2017
  • TOP STORY: Collins to remain NIH director

    NIH Director Francis Collins will be "held over" by the Trump administration, spokesperson Renate Myles told BioCentury.On Wednesday, Myles said Collins would resign his post if he were not asked to stay by noon on Jan.…

    Published on 1/19/2017
  • TOP STORY: Lilly acquiring CoLucid

    Eli Lilly and Co. (NYSE:LLY) is acquiring migraine company CoLucid Pharmaceuticals Inc. (NASDAQ:CLCD) for $46.50 per share in cash, or about $960 million. The price is a 33% premium to CoLucid's close Tuesday of $34.90,…

    Published on 1/18/2017
  • TOP STORY: FDA releases interchangeability guidance

    In long-anticipated draft guidance on interchangeability of biosimilars, FDA said it will require most biosimilars' sponsors to conduct studies showing that switching between a biosimilar and its reference product poses…

    Published on 1/17/2017
  • TOP STORY: SCOTUS to review biosimilar launch timelines

    The U.S. Supreme Court granted a petition from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to review a lower court's interpretation of the Biologics Price Competition and Innovation Act (BPCIA) that effectively …

    Published on 1/13/2017
  • TOP STORY: FDA finalizes biologics naming guidance

    In final guidance released Thursday on naming of biologic drugs, FDA reiterated that each biologic should receive a non-proprietary "core name" plus a unique four-letter suffix that is devoid of meaning. The naming …

    Published on 1/12/2017
  • TOP STORY: Trump lashes out at drug industry

    At a press conference Wednesday morning, President-elect Donald Trump advocated government negotiation of drug prices as Senate leaders prepared for a series of votes on healthcare issues, including Medicare drug price …

    Published on 1/11/2017
  • TOP STORY: Sarepta discusses Exondys 51 sales, DMD pipeline

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) soared $6.63 (21%) to $37.89 on Tuesday following a presentation in which President, CEO and CMO Edward Kaye reported initial sales of Exondys 51 eteplirsen and provided an update…

    Published on 1/10/2017
  • TOP STORY: Takeda acquiring Ariad

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) will acquire cancer company Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) for $24 per share in cash, or about $5.2 billion. The price is a 75% premium to Ariad's close Friday of $…

    Published on 1/9/2017
  • TOP STORY: Ionis, Novartis forge cardiovascular deal

    Ionis Pharmaceuticals Inc. (NASDAQ:IONS) and its Akcea Therapeutics subsidiary granted Novartis AG (NYSE:NVS; SIX:NOVN) exclusive, worldwide options to develop and commercialize AKCEA-APO(a)-LRx (IONIS-APO(a)-LRx) and …

    Published on 1/6/2017
  • TOP STORY: Judge orders ban on Praluent sales

    A federal judge granted Amgen Inc. (NASDAQ:AMGN) a permanent injunction banning U.S. sales of rival cholesterol-lowering drug Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:…

    Published on 1/5/2017
  • TOP STORY: RaNA acquires mRNA platform from Shire

    RaNA Therapeutics Inc. (Cambridge, Mass.) said it acquired the MRT mRNA therapeutic platform from Shire plc (LSE:SHP; NASDAQ:SHPG). The platform enables mRNA replacement, which can correct mutations or defects within …

    Published on 1/4/2017
  • TOP STORY: Ascletis raises $100M in series B

    Ascletis BioScience Co. Ltd. (Hangzhou, China) raised $100 million in a series B round led by C-Bridge Capital. New investors QianHai Equity Investment, Focus Media Jiangnanchun Foundation and WTT Investment also …

    Published on 1/3/2017
  • TOP STORY: Biotechs' weak year ends

    Biotech stocks finished their disappointing year by falling 11% in 4Q16. The BioCentury 100 ended the year down 1,474.40 (23%) to 4,834.54, and far underperformed the broader markets.The NASDAQ Biotechnology Index (NBI)…

    Published on 12/30/2016
  • TOP STORY: FDA approves Spinraza in SMA

    FDA approved Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) to treat children and adults with spinal muscular atrophy (SMA). It is the first drug approved for the …

    Published on 12/23/2016
  • TOP STORY: Roche's emicizumab passes Phase III hemophilia A test

    Roche (SIX:ROG; OTCQX:RHHBY) said emicizumab (ACE910) met the primary endpoint of the Phase III HAVEN 1 study as a prophylaxis for hemophilia A in patients with Factor VIII inhibitors. Compared with patients who …

    Published on 12/22/2016
  • TOP STORY: Senate price gouging panel doesn't recommend price controls

    In a report on allegedly unjustified price increases of off-patent drugs, the U.S. Senate Committee on Aging recommended legislative remedies that would support generic competition and prevent market manipulation but …

    Published on 12/21/2016
  • TOP STORY: Senate Dems call on Trump to address drug pricing

    In a letter to Donald Trump, U.S. Senators Sherrod Brown (D-Ohio), Al Franken (D-Minn.) and 18 colleagues called on the President-elect to make good on campaign promises to address prescription drug pricing. The …

    Published on 12/20/2016
  • TOP STORY: Biogen taps insider Vounatsos to succeed CEO Scangos

    Biogen Inc. (NASDAQ:BIIB) said EVP and Chief Commercial Officer Michel Vounatsos will succeed George Scangos as CEO, effective Jan. 6, 2017. Biogen said in July that Scangos would retire once the company identified a …

    Published on 12/19/2016
  • TOP STORY: Actelion surges again as Sanofi rumors intensify

    Actelion Ltd. (SIX:ATLN) added CHF20.70 (10%) to CHF218.20 on Friday after media reports said Sanofi (Euronext:SAN; NYSE:SNY) was nearing a deal to acquire the Swiss biotech. Actelion shares have now risen 38% since …

    Published on 12/16/2016
  • TOP STORY: Jury awards Merck $2.5B in Gilead patent dispute

    A federal jury ordered Gilead Sciences Inc. (NASDAQ:GILD) to pay Merck & Co. Inc. (NYSE:MRK) $2.5 billion in damages in an HCV patent infringement lawsuit. According to the jury's verdict, the damages are based on a 10%…

    Published on 12/15/2016
  • TOP STORY: Actelion sinks after J&J ends deal talks

    Actelion Ltd. (SIX:ATLN) lost CHF19.20 to CHF189.30 on Wednesday, shedding about CHF2.1 billion ($2 billion) in market cap, after Johnson & Johnson (NYSE:JNJ) said late Tuesday that it has ended discussions with the …

    Published on 12/14/2016
  • TOP STORY: Obama signs 21st Century Cures into law

    On Tuesday, President Obama signed the 21st Century Cures Act into law. The bill contains provisions to fund a handful of high-profile NIH initiatives, creates an approval pathway for antibiotics targeting drug-…

    Published on 12/13/2016
  • TOP STORY: Top Alexion execs leave as investigation continues

    Rare disease company Alexion Inc. (NASDAQ:ALXN) lost $16.99 (13%) to $115.08 on Monday after it said CEO David Hallal and CFO Vikas Sinha have left the company. The moves come as Alexion continues to investigate a …

    Published on 12/12/2016
  • TOP STORY: Biogen, AC Immune swing on AD readouts

    Biogen Inc. (NASDAQ:BIIB) shares seesawed Thursday and Friday, propelled upward by data showing that aducanumab (BIIB037) cleared amyloid plaques and improved cognition in an exploratory analysis of a Phase Ib study to …

    Published on 12/9/2016

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