Industry News

• Anika announces regulatory approval for MONOVISC(R) in Australia for treatment of pain  Anika Therapeutics announced that regulatory authorities in Australia granted approval to MONOVISC®, Anika's single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee.
  October 16, 2017  
• FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab)  Bristol-Myers Squib announced the FDA has accepted for priority review its sBLA for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
  October 16, 2017  
• Immune Design announces positive FDA feedback on phase 3 clinical trial design for CMB305   Immune Design announced that based on productive discussions with the FDA, it plans to initiate a pivotal Phase 3 trial to support a Biologics License Application for CMB305, a novel cancer vaccine, in patients with synovial sarcoma.
  October 16, 2017  
• Abeona Therapeutics announces public offering of common stock  Abeona announced it intends to offer and sell shares of its common stock in an underwritten public offering pursuant to an existing shelf registration statement. All of the shares in the offering are to be sold by Abeona.
  October 16, 2017  
• Amgen and Boston Children's Hospital enter collaboration to target new pain genes  Amgen and Boston Children's Hospital announced a neuroscience research collaboration aimed at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity.
  October 16, 2017  
• Einstein researchers share $9 million grant to find anti-aging therapies  Researchers at Albert Einstein College of Medicine have been awarded a $3 million grant from the Glenn Foundation for Medical Research to continue a series of studies on longevity and age-related diseases.
  October 16, 2017  
• TGen develops processing procedures for ‘single-cell’ sequencing  TGen announced grant support from the Chan Zuckerberg Initiative donor advised fund, an advised fund of the Silicon Valley Community Foundation, that will help revolutionize how researchers identify the genetic source of diseases and how best to treat each patient.
  October 16, 2017  
• Arbutus announces closing of $50 million first tranche of $116.4 million investment  Arbutus Biopharma and Roivant Sciences Ltd. announced the closing of the issue and sale of 500,000 convertible series A preferred shares by Arbutus to Roivant for gross proceeds to Arbutus of US$50 million.
  October 16, 2017  
• Halozyme nitiates clinical trial Of PEGPH20 with anti-PDL1 immunotherapy  Halozyme announced initiation of a clinical trial evaluating its investigational new drug PEGPH20 with atezolizumab (TECENTRIQ®), an anti-PDL1 cancer immunotherapy from Genentech in patients with previously untreated, unresectable or metastatic cholangiocarcinoma and gallbladder adenocarcinoma.
  October 16, 2017  
• Exelixis announces FDA grants Priority Review for CABOMETYX® (Cabozantinib)  Exelixis announced the FDA has determined the company’sNDA for CABOMETYX® (cabozantinib) for patients with previously untreated advanced renal cell carcinoma to be sufficiently complete to permit a substantive review. The FDA granted assigned a PDUFA action date of February 15, 2018.
  October 16, 2017  

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