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  • TOP STORY: CMS outlines biosimilar reimbursement

    In biosimilar reimbursement documents issued Tuesday, CMS removed an incentive for physicians to prescribe more expensive Medicare Part B innovator drugs and opened the door to formulary exclusions of innovator drugs …

    Published on 3/31/2015
  • TOP STORY: Teva acquiring CNS play Auspex for $3.5B

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is buying neurology play Auspex Pharmaceuticals Inc. (NASDAQ:ASPX) for $101 per share, or $3.5 billion in cash. The price is a 42% premium to Auspex's Friday close of $70.…

    Published on 3/30/2015
  • TOP STORY: BioMarin rises on takeout rumors

    Rare disease company BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) jumped $13.23 (11%) to $128.78 on Friday, ending the day with a market cap of $20.5 billion, amid rumors that Shire plc (LSE:SHP; NASDAQ:SHPG) has …

    Published on 3/27/2015
  • TOP STORY: Biotech stocks steady after Wednesday's slide

    Biotech stocks traded relatively flat Thursday, recovering from moderate losses in intraday trading. The sector posted sharp declines earlier in the week as some investors feared that biotechs have become overvalued …

    Published on 3/26/2015
  • TOP STORY: Biotech stocks pummeled on bubble fears

    Biotech stocks took a beating Wednesday on fears that companies in the sector have become overvalued after an extended updraft. The Wall Street Journal published a story highlighting investor anxiety over the bull run, …

    Published on 3/25/2015
  • TOP STORY: Keytruda tops Yervoy in first-line melanoma

    Merck & Co. Inc. (NYSE:MRK) said an interim analysis of a Phase III trial showed Keytruda pembrolizumab was superior to Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY) on the co-primary endpoints of …

    Published on 3/24/2015
  • TOP STORY: Lawmakers introduce permanent Priority Review voucher bill

    Five U.S. Representatives introduced the Advancing Hope Act of 2015, a bill that would reauthorize and make permanent the Priority Review voucher incentive program for rare pediatric diseases. The bill's sponsors …

    Published on 3/23/2015
  • TOP STORY: Biogen climbs on early Alzheimer's data

    Biogen Idec Inc. (NASDAQ:BIIB) gained $42.33 (10%) to $475.98 on Friday after reporting detailed Phase Ib data for Alzheimer's disease (AD) candidate aducanumab (BIIB037).Aducanumab led to statistically significant …

    Published on 3/20/2015
  • TOP STORY: Researchers call for gene editing caution

    Advances in the use of the gene editing technology CRISPR for germline modifications have prompted a group of academic researchers and bioethicists to call for a conference of stakeholders to manage public concerns and …

    Published on 3/19/2015
  • TOP STORY: Stakeholders aiming to renew pediatric voucher program

    FDA issued its third Priority Review voucher under its pediatric disease voucher program Tuesday, which triggers a 12-month clock until the pilot program ends. The program is intended to give pharma companies incentives…

    Published on 3/18/2015
  • TOP STORY: Nektar misses in breast cancer

    Nektar Therapeutics (NASDAQ:NKTR) said etirinotecan pegol (NKTR-102) missed the primary endpoint of an improvement in median overall survival in the Phase III BEACON trial in metastatic breast cancer. Patients treated …

    Published on 3/17/2015
  • TOP STORY: PCSK9 inhibitors continue neck-and-neck

    In newly published analyses, the PCSK9 inhibitors Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) and Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed …

    Published on 3/16/2015
  • TOP STORY: FDA: Some breakthroughs faster than others

    As the queue of breakthrough designation candidates grows longer, FDA is setting standards for determining which of the applications will get the fastest reviews.In a new Manual of Policies and Procedures (MAPP) that …

    Published on 3/13/2015
  • TOP STORY: Epizyme jumps after buying back rights from Eisai

    Wall Street reversed course on Epizyme Inc. (NASDAQ:EPZM) on Thursday, driving the stock up $3.27 (15%) to $25.45 after initially selling shares on news the biotech is paying $40 million up front to Eisai Co. Ltd. (…

    Published on 3/12/2015
  • TOP STORY: Endo the road for Salix

    Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) gained $10.96 to $168.61 after Endo International plc (NASDAQ:ENDP; TSX:ENL) attempted to outbid Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) with a buyout …

    Published on 3/11/2015
  • TOP STORY: Janssen seeking to block Remicade biosimilar

    A suit filed by the Janssen Inc. unit of Johnson & Johnson (NYSE:JNJ) and by New York University against Celltrion Inc. (KOSDAQ:068270) and Hospira Inc. (NYSE:HSP) seeks to delay or block the U.S. launch of CT-P13, a …

    Published on 3/10/2015
  • TOP STORY: FDA panel backs Kythera's double-chin treatment

    FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted 17-0 to back approval of ATX-101 deoxycholic acid from Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH) to reduce submental (under chin) fat. The …

    Published on 3/9/2015
  • TOP STORY: FDA approves Zarxio, first biosimilar in U.S.

    FDA approved Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for the same indications as its reference product, Neupogen filgrastim methionyl human G-CSF from Amgen Inc. (NASDAQ:AMGN). …

    Published on 3/6/2015
  • TOP STORY: AbbVie investors lukewarm on Pharmacyclics deal

    AbbVie Inc. (NYSE:ABBV) shed $3.41 to $56.86 on news of its $21 billion acquisition of oncology play Pharmacyclics Inc. (NASDAQ:PCYC), a signal that shareholders are questioning whether the deal will fill AbbVie's …

    Published on 3/5/2015
  • TOP STORY: Quick FDA approval for Opdivo in NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) jumped $3.75 to $65.67 on Tuesday after FDA approved an sBLA for Opdivo nivolumab to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) who have progressed on …

    Published on 3/4/2015
  • TOP STORY: Release of Contrave data validates FDA's demand for second trial

    Orexigen Therapeutics Inc. (NASDAQ:OREX) gained $1.85 (32%) to $7.64 after an interim analysis of the LIGHT cardiovascular (CV) outcomes study showed that the company's obesity drug Contrave naltrexone/bupropion may …

    Published on 3/3/2015
  • TOP STORY: Kyprolis superior to Velcade in second-line MM

    Amgen Inc. (NASDAQ:AMGN) said Kyprolis carfilzomib plus dexamethasone met the primary endpoint of superiority over Velcade bortezomib plus dexamethasone in a planned interim analysis of the Phase III ENDEAVOR trial in …

    Published on 3/2/2015
  • TOP STORY: FDA gets feedback on next-generation sequencing

    As FDA digests comments from last week's next-generation sequencing (NGS) workshop, Elizabeth Mansfield, the deputy office director for personalized medicine at the agency's Center for Devices and Radiological Health (…

    Published on 2/27/2015
  • TOP STORY: FDA approves Sanofi's Toujeo

    Sanofi (Euronext:SAN; NYSE:SNY) said FDA approved its Toujeo insulin glargine to improve glycemic control in adults with Type I and Type II diabetes. Sanofi expects to launch the drug and announce its price early next …

    Published on 2/26/2015
  • TOP STORY: FDA approves Avycaz for cUTIs and cIAI

    FDA approved an NDA for Avycaz ceftazidime/avibactam from Actavis plc (NYSE:ACT) to treat complicated urinary tract infections (cUTIs) and in combination with metronidazole to treat complicated intra-abdominal …

    Published on 2/25/2015

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