Industry News

• FDA grants orphan-drug designation to Astellas for development of FLT3 inhibitor for AML  Astellas Pharma announced the FDA granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia. Gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in the growth of cancer cells.
  July 20, 2017  
• Incyte announces first patient treated in phase 3 clinical trial of itacitinib for GVD  Incyte announced that the first patient has been treated in GRAVITAS-301, a pivotal Phase 3 trial for first-line treatment of patients with acute graft-versus-host disease. The trial will evaluate efficacy and safety of itacitinib, Incyte's novel, potent, and selective JAK1 inhibitor.
  July 20, 2017  
• Nivalis Therapeutics stockholders approve merger and reorganization plan  Nivalis Therapeutics announced that stockholders approved all of the merger-related proposals with and Alpine Immune Sciences. Nivalis' name will change to “Alpine Immune Sciences, Inc.” The closing of the merger is expected to occur on July 24, 2017.
  July 20, 2017  
• ContraFect prices $40 pillion public offering of common stock and warrants  ContraFect announced pricing of its underwritten public offering of 32,000,000 shares of its common stock and related warrants to purchase 16,000,000 shares of common stock with an exercise price of $1.55 per share at a combined public offering price of $1.25 per share and related warrant.
  July 20, 2017  
• Abbott reports second-quarter 2017 results  Abbott reported second-quarter 2017 worldwide sales of $6.6 billion, an increase of 24.4 percent on a reported basis and 2.9 percent on a comparable operational basis over the prior year period. Diluted GAAP EPS from continuing operations was $0.15 in the second quarter.
  July 20, 2017  
• Merck announces FDA grants tentative approval for LUSDUNA™ Nexvue™  Merck announced the FDA has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.
  July 20, 2017  
• Exelixis announces settlement of dispute with Genentech   Exelixis announced a settlement of the company’s dispute with Genentech concerning their collaboration for development and commercialization of cobimetinib, marketed as COTELLIC®. The companies entered into an amendment to revise the revenue and cost-sharing arrangements for the collaboration.
  July 20, 2017  
• Apollo Endosurgery announces pricing of $31 million public offering   Apollo Endosurgery announced pricing of an underwritten public offering of 5,689,090 shares of its common stock at a public offering price of $5.50 per share. Apollo also granted underwriters a 45-day option to purchase up to an additional 853,363 shares of common stock.
  July 20, 2017  
• NICE recommends CINQAERO® (reslizumab) for treatment of severe eosinophilic asthma  Teva announced that the NICE in England has recommended CINQAERO® (reslizumab) in its Final Appraisal Determination. CINQAERO® is a humanized interleukin-5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma.
  July 20, 2017  
• Pfizer completes agreement for exclusive commercialization rights in Europe for CRESEMBA  Pfizer announced they have completed the licensing agreement whereby Pfizer has obtained the exclusive commercialization rights in Europe to CRESEMBA (isavuconazole), a novel anti-fungal treatment for adult patients with diagnosed invasive aspergillosis and mucormycosis.
  July 20, 2017  

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