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  • TOP STORY: Pfizer decides against splitting in two

    Pfizer Inc. (NYSE:PFE) said Monday it will not split its innovative and established products businesses into two separate publicly traded companies, and will continue to operate as one company. The company investigated …

    Published on 9/26/2016
  • TOP STORY: FDA approves Amgen's biosimilar of Humira

    FDA approved Amjevita adalimumab-atto (ABP 501) from Amgen Inc. (NASDAQ:AMGN), a biosimilar of Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). The agency approved Amjevita for all indications Amgen had sought: …

    Published on 9/23/2016
  • TOP STORY: AC Immune prices $66M IPO

    Neurodegeneration company AC Immune S.A. (NASDAQ:ACIU) raised $66 million through the sale of 6 million shares at $11 in an IPO underwritten by Credit Suisse, Jefferies and Leerink. The price valued the company at $609.…

    Published on 9/22/2016
  • TOP STORY: Chan, Zuckerberg pledge $3B for disease research

    The Chan Zuckerberg Initiative said it will invest more than $3 billion over 10 years in an effort to cure, manage or prevent all diseases by the end of the century. Priscilla Chan and Mark Zuckerberg founded the …

    Published on 9/21/2016
  • TOP STORY: Allergan acquiring NASH companies Tobira, Akarna

    Allergan plc (NYSE:AGN) said Tuesday it had acquired a pair of companies with "complementary" assets to treat non-alcoholic steatohepatitis. Before market hours, it said it would buy Tobira Therapeutics Inc. (NASDAQ:…

    Published on 9/20/2016
  • TOP STORY: FDA approves Sarepta's eteplirsen, first DMD drug

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) soared $20.79 (74%) to $48.94 on Monday after FDA granted accelerated approval to the company's Exondys 51 eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) …

    Published on 9/19/2016
  • TOP STORY: HHS, NIH expanding mandates

    HHS released a final rule that will require some sponsors to report summary clinical results to regardless of whether a compound or device has been approved. The rule applies to interventional studies…

    Published on 9/16/2016
  • TOP STORY: Novavax crumbles after Phase III RSV failure

    Novavax Inc. (NASDAQ:NVAX) plummeted $6.94 (83%) to $1.40 in early after-hours trading Thursday after its RSV F vaccine missed the primary endpoint in the Phase III Resolve trial to prevent respiratory syncytial virus (…

    Published on 9/15/2016
  • TOP STORY: Allergan acquiring Vitae

    Allergan plc (NYSE:AGN) is acquiring Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) for $21 per share in cash, or about $639 million. The price is a 159% premium to Vitae's close of $8.10 on Tuesday, before the deal was …

    Published on 9/14/2016
  • TOP STORY: Competing drug pricing visions aired

    On Tuesday, a group of six biotech CEOs and a generic drug industry advocate outlined competing visions to address controversies over the price of prescription drugs. In a commentary posted on Forbes, the CEO group drew…

    Published on 9/13/2016
  • TOP STORY: Horizon acquiring Raptor

    Horizon Pharma plc (NASDAQ:HZNP) is buying Raptor Pharmaceutical Corp. (NASDAQ:RPTP) for $9 per share in cash, or about $800 million. The price is a 21% premium to Raptor's close of $7.45 on Friday, before the deal was …

    Published on 9/12/2016
  • TOP STORY: Phase III diabetes readout boosts Lexicon

    Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) jumped $2.54 (17%) to $17.85 on Friday after it said sotagliflozin (SAR439954) met the primary endpoint in the Phase III Tandem1 study to treat Type I diabetes. Compared with …

    Published on 9/9/2016
  • TOP STORY: Express Scripts' inflammatory program to offer indication-based pricing

    Express Scripts Holding Co. (NASDAQ:ESRX) introduced its Inflammatory Conditions Care Value Program, an optional program for Express Scripts clients aimed at controlling costs and improving care for patients with …

    Published on 9/8/2016
  • TOP STORY: Agios rises as IDH2 inhibitor heads for submission

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO) jumped $9.66 (26%) to $46.98 on Wednesday after disclosing that partner Celgene Corp. (NASDAQ:CELG) plans to submit an NDA to FDA by year end seeking approval of enasidenib (AG-…

    Published on 9/7/2016
  • TOP STORY: CoLucid soars on Phase III migraine readout

    CoLucid Pharmaceuticals Inc. (NASDAQ:CLCD) rocketed $13.17 (124%) to $23.83 on Tuesday after reporting that both doses of lasmiditan (oral COL-144) met the primary endpoint in the Phase III SAMURAI trial to treat acute …

    Published on 9/6/2016
  • TOP STORY: Hillary Clinton releases plan on drug prices

    Hillary Clinton released a drug price control plan Friday that echoes measures she championed in the early 1990s, such as creation of a government body to assess and respond to drug prices. Clinton also said that if …

    Published on 9/2/2016
  • TOP STORY: Tecentriq meets in Phase III lung cancer study

    Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said Tecentriq atezolizumab (MPDL3280A) met the co-primary endpoints in the open-label Phase III OAK study of the PD-L1 inhibitor as a second-line treatment for …

    Published on 9/1/2016
  • TOP STORY: Sunovion to acquire Cynapsus for $624M

    The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) announced after market close Wednesday that it will acquire neurology company Cynapsus Therapeutics Inc. (TSX:CTH; NASDAQ:CYNA) …

    Published on 8/31/2016
  • TOP STORY: FDA approves Sandoz's Enbrel biosimilar

    The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved a BLA for Erelzi etanercept-szzs (GP2015), a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). Erelzi is approved in all indications …

    Published on 8/30/2016
  • TOP STORY: Moderna raises $451.4M, per SEC filing

    mRNA therapeutics company Moderna Therapeutics Inc. (Cambridge, Mass.) has raised $451.4 million towards a planned $600 million venture round, according to an SEC filing from last week. The new financing would bring …

    Published on 8/29/2016
  • TOP STORY: Maraganore replaces Tessier-Lavigne as Agios chairman

    Cancer and Orphan disease company Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said Marc Tessier-Lavigne resigned as its chairman "due to other commitments." John Maraganore, a director who is also CEO of Alnylam …

    Published on 8/26/2016
  • TOP STORY: Denali unveils $130M funding, series of deals

    Denali Therapeutics Inc. (South San Francisco, Calif.) disclosed Thursday that it raised $130 million in a series B round and made five deals to flesh out its pipeline. The company is pursuing neurodegenerative diseases…

    Published on 8/25/2016
  • TOP STORY: Biotechs slide after Clinton's EpiPen comments

    In a statement responding to price increases for EpiPen from Mylan N.V. (NASDAQ:MYL), Hillary Clinton slammed drug companies that "put profits ahead of patients, raising prices without justifying the value behind them.…

    Published on 8/24/2016
  • TOP STORY: Clovis jumps on Priority Review for rucaparib

    Clovis Oncology Inc. (NASDAQ:CLVS) gained $4.93 (27%) to $23.03 on Tuesday after it said FDA accepted and granted Priority Review to an NDA seeking accelerated approval of rucaparib (CO-338) as monotherapy in patients …

    Published on 8/23/2016
  • TOP STORY: Pfizer acquiring Medivation

    Pfizer Inc. (NYSE:PFE) is acquiring Medivation Inc. (NASDAQ:MDVN) for $81.50 per share in cash, or about $14 billion. Medivation had negotiated with multiple parties after it rejected unsolicited bids from Sanofi (…

    Published on 8/22/2016

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