Industry News

• Achaogen submits MAA to the European Medicines Agency for Plazomicin  Achaogen announced the submission of a Marketing Authorization Application to the EMA) for plazomicin. The Company is seeking approval for Complicated urinary tract infections, including pyelonephritis, Bloodstream infections.
  October 17, 2018  
• Albireo granted Orphan Drug Designation for lead product candidate A4250  Albireo Pharma announced the FDA has granted Orphan Drug Designation to lead product candidate A4250, an ileal bile acid transporter inhibitor, for the treatment of Alagille syndrome, a rare and life-threatening disease that affects the liver and has no approved pharmacologic treatment option.
  October 17, 2018  
• Rexahn announces $7.5 million registered direct offering  Rexahn Pharmaceuticals announced it has entered into definitive agreements with institutional investors to purchase 5.77 million shares of its common stock and warrants exercisable for up to 5.77 million shares of its common stock for gross proceeds of $7.5 million.
  October 17, 2018  
• Iovance Biotherapeutics announces closing of $252 million common stock public offering  Iovance Biotherapeutics announced the closing of an underwritten public offering of 25,300,000 shares of its common stock at a public offering price of $9.97 per share. Gross proceeds are $252.2 million.
  October 17, 2018  
• IMRALDI™, Biogen’s adalimumab biosimilar referencing Humira®, is launched in the EU  Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen announced the European launch of IMRALDITM, an adalimumab biosimilar referencing Humira®.
  October 17, 2018  
• Evotec and Ferring form strategic research alliance in reproductive medicine  Evotec and Ferring Pharmaceuticals announced a strategic research alliance to discover and develop new small molecule therapies to treat patients living with fertility and gynaecological conditions. As part of the alliance, Evotec is eligible for undisclosed research funding and milestones.
  October 17, 2018  
• Boston Scientific closes acquisition of Augmenix  Boston Scientific announced the close of its acquisition of Augmenix, a privately-held company that developed and commercialized the SpaceOAR® Hydrogel System. Boston Scientific acquired Augmenix for $500 million in up-front cash and up to $100 million for reaching sales-based milestones.
  October 16, 2018  
• Medovex to acquire pulmonary services and delivery platform of Regenerative Medicine  Medovex announced that it has signed a definitive agreement to acquire the pulmonary biomedical services and patient delivery platform of Regenerative Medicine Solutions in an all-stock transaction.
  October 16, 2018  
• Five Prime Therapeutics initiates patient dosing in phase 1 trial of B7-H4 antibody FPA150  Five Prime Therapeutics announced that it initiated patient dosing in the dose exploration cohort of its ongoing Phase 1 clinical trial of FPA150 (FPA150-001; NCT03514121), a targeted, first-in-class immuno-oncology antibody that targets B7-H4.
  October 16, 2018  
• Lexicon Pharma and Ipsen Biopharmaceuticals announce Health Canada approval of XERMELO®  Lexicon Pharmaceuticals and Ipsen Biopharmaceuticals Canada announced that Health Canada has approved XERMELO® (telotristat ethyl) 250 mg as a first and only orally administered therapy for treatment of refractory carcinoid syndrome diarrhea in combination with somatostatin analog therapy.
  October 16, 2018  

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