Industry News

• FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies  The FDA authorized marketing of a diagnostic test to detect Zika virus immunoglobulin antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S..
  May 24, 2019  
• Aptose Biosciences establishes new at-the-market facility  Aptose Biosciences announced it has entered into an “at-the-market” sales agreement with Piper Jaffray and Canaccord Genuity. This ATM replaces the previous ATM that the Company entered into with Cantor Fitzgerald in 2018.
  May 24, 2019  
• Insmed announces closing of public offering of common stock  Insmed announced the closing of the previously announced public offering of its common stock. Insmed issued and sold in the public offering 9,615,385 shares of common stock, at a public offering price of $26.00 per share, resulting in gross proceeds of $250.0 million.
  May 24, 2019  
• REGENXBIO announces first FDA approval of gene therapy based on its proprietary NAV®  REGENXBIO announced the first FDA approval of a gene therapy that leverages REGENXBIO's proprietary NAV Technology Platform, Novartis AG's ZOLGENSMA® (onasemnogene abeparvovec-xioi; AVXS-101). ZOLGENSMA was approved by the FDA as a one-time infusion for pediatric patients with SMA.
  May 24, 2019  
• FDA approves Jakafi® (ruxolitinib) for treatment of patients with acute GVHD  Incyte announced the FDA has approved Jakafi® (ruxolitinib) for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication.
  May 24, 2019  
• FDA approves Novartis Piqray® for patients with PIK3CA mutation in HR+/HER2 MBC  Novartis announced the FDA has approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative, PIK3CA-mutated, advanced or metastatic breast cancer.
  May 24, 2019  
• Ekso Bionics announces closing of $10 million public offering  Ekso Bionics announced the closing of its underwritten public offering of 6,666,667 shares of its common stock and accompanying warrants to purchase 6,666,667 shares of its common stock, at a price to the public of $1.50 per share and accompanying warrant to purchase one share of common stock.
  May 24, 2019  
• Measles outbreak puts cancer patients at risk  In the year 2000, measles was declared eliminated in the U.S. This year, there have been more than 839 new cases of measles — a sharp increase from the 372 cases reported in 2018. Even if patients have been vaccinated before, certain cancer treatments may render vaccines ineffective.
  May 24, 2019  
• Bristol-Myers announces extension of expiration date for Celgene exchange offer  Bristol-Myers Squibb announced the extension of the expiration date of the offers to exchange notes issued by Celgene Corporation for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb.
  May 24, 2019  
• Vectura receives $2.5 m milestone payment for tEuropean regulatory submission of QVM149  Vectura announced it will receive a $2.5million milestone payment under an exclusive licence agreement with Novartis. The payment was triggered following acceptance of Novartis' valid MAA by the EU Regulatory Authorities for the regulatory approval of QVM149.
  May 24, 2019  

   (next 10 articles)