Industry News

• Medtronic receives CE Mark approval for Valiant Navion(TM) thoracic stent graft system  Medtronic announced it has received CE Mark approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including TAA, BTAI, PAU, IMH, and TBAD.
  November 13, 2018  
• BioSig Technologies announces new research program with Mayo Clinic  BioSig Technologies announced that the Company entered into a new advanced research agreement with Mayo Clinic. The program will focus on development of additional advanced features of PURE EP(tm) System within the field of electrophysiology in a new, previously unexplored, field.
  November 13, 2018  
• Mayo Clinic School of Medicine receives $200 million gift  Mayo Clinic has announced a gift of $200 million from Jay Alix, noted philanthropist of Birmingham, Mich. and founder of the firm, AlixPartners. The endowment gift, the largest ever to the Mayo Clinic, is designated to Mayo Clinic School of Medicine.
  November 13, 2018  
• Eyenovia announces FDA acceptance of MicroStat IND application for mydriasis  Eyenovia announced the FDA has accepted the Company’s Investigational New Drug application to initiate Phase III trials of MicroStat for diagnostic mydriasis. MicroStat is a first in class fixed-combination of phenylephrine and tropicamide for in office mydriasis (pupil dilation).
  November 13, 2018  
• FDA accepts for filing Shire’s sNDA for GATTEX® (teduglutide [rDNA origin]) for SBS  Shire announced the FDA has accepted for filing the supplemental new drug application to extend the indication of GATTEX® (teduglutide [rDNA origin]) for Injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome who are dependent on parenteral support.
  November 13, 2018  
• Bausch Health to expand contact lens manufacturing facilities in New York and Ireland  Bausch Health announced it will expand contact lens manufacturing capacity at its sites in Rochester, N.Y. and Waterford, Ireland. The Company is adding multiple production lines at these two sites to support the manufacture of its innovative daily disposable silicone hydrogel contact lenses.
  November 13, 2018  
• InvaGen announces acquisition agreement with Avenue Therapeutics for hospital business  InvaGen, a Cipla subsidiary, announced agreements with two closing stages for a proposed acquisition of Avenue Therapeutics, a Fortress Biotech company focused on development and commercialization of intravenous Tramadol.
  November 13, 2018  
• CytoDyn’s PRO 140 (leronlimab) HIV monotherapy trial results show 92% responder’s rate  CytoDyn reported that to date, 92% (or 24 out of 26) newly enrolled patients administered PRO 140 700 mg in the CD03 Phase 3 investigative monotherapy trial treated for up to 12 weeks have achieved viral load suppression. Patients enrolled were prescreened for CCR5-tropic HIV-1 infection.
  November 13, 2018  
• FDA grants priority review to Roche's Tecentriq in combination with Abraxane for TNBC  Roche announced the FDA has accepted the company's sBLA and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for initial treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
  November 13, 2018  
• Cyanotech reports financial results for second quarter of 2019  Cyanotech reported the net loss was ($1,136,000) or ($0.20) per diluted share in the 2019 second quarter, compared to net income of $475,000 or $0.08 per diluted share in the prior year period. Net sales were $6,954,000 in the 2019 second quarter compared to $8,055,000 in the same 2018 period.
  November 12, 2018  

   (next 10 articles)