Industry News

• Vertex receives European CHMP positive opinion for KALYDECO® (ivacaftor) to treat CF  Vertex Pharmaceuticals announces the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for KALYDECO® (ivacaftor) to include treatment of people with cystic fibrosis aged 12 to <24 months who have at least one of nine mutations in their CFTR gene.
  October 19, 2018  
• CHMP Recommends EU marketing authorisation of lanadelumab for prevention of HAE attack  Shire announced the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of marketing authorisation of lanadelumab injection for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years and older.
  October 19, 2018  
• Mylan and Biocon announce positive CHMP opinion for Ogivri®, Biosimilar Trastuzumab  Mylan and Biocon announced that the EMA's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Ogivri®, a biosimilar to Roche's Herceptin® (trastuzumab). The decision on approval is expected by the end of 2018.
  October 19, 2018  
• Abbott's HeartMate 3 heart pump now FDA approved for advanced heart failure   Abbott announced the HeartMate 3™ Left Ventricular Assist Device has received FDA approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant.
  October 19, 2018  
• Amneal announces approval and launch of generic isoproterenol hydrochloride injection   Amneal Pharmaceuticals announced that it has received FDA approval for a generic version of IsuprelTM Injection (isoproterenol hydrochloride) USP, 0.2 mg/mL and 1 mg/5 mL(0.2 mg/mL) Single-Dose Vials. The Company has immediately initiated commercialization activities.
  October 19, 2018  
• Merrimack discontinues phase 2 SHERLOC study of MM-121 in patients with NSCLC  Merrimack announced termination of the SHERLOC study, its randomized, open-label Phase 2 clinical trial evaluating MM-121 in combination with docetaxel in patients with heregulin positive NSCLC. This decision was made following an interim analysis.
  October 19, 2018  
• Mylan adds to women's healthcare portfolio with launch of generic Depo-Provera® injection  Mylan announced the U.S. launch of Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL Single-Dose Vial, a generic version of the brand drug, Pfizer's Depo-Provera®. U.S. sales for MPA were approximately $181 million for the 12 months ending July 31, 2018, according to IQVIA.
  October 19, 2018  
• Genomic analysis offers insight into 2018 Nigeria Lassa fever outbreak  A surge in Lassa fever cases in Nigeria in 2018 does not appear to be linked to a single virus strain or increased human-to-human transmission, according to a genomic analysis published in The New England Journal of Medicine.
  October 18, 2018  
• Cancer Genetics enters strategic partnership with Genecast Biotechnology in China  Cancer Genetics announced it has signed an exclusive distribution agreement with Genecast Biotechnology to market, distribute and sell the Tissue of Origin® Test in China. TOO is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin.
  October 18, 2018  
• Amgen invests £50 million ($66 Million) in Oxford Nanopore Technologies  Amgen and Oxford Nanopore Technologies announced Amgen's equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.
  October 18, 2018  

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