Industry News

• NIH scientists illuminate causes of hepatitis b virus-associated acute liver failure  NIH and their collaborators found that HBV-associated acute liver failure results from an uncommon encounter between a highly mutated HBV variant and an unusual immune response in the patient’s liver that is mainly sustained by antibody-producing B cells. The study is published in PNAS.
  November 13, 2018  
• Burcon announces execution of loan agreement  Burcon announced it has entered into a loan agreement pursuant to which Large Scale Investments, a wholly-owned subsidiary of Firewood Elite, will provide Burcon with an unsecured loan of up to $1,000,000 for a term of six months. Firewood is wholly-owned by Mr. Alan Chan, a director of Burcon.
  November 13, 2018  
• FDA to allow greater flexibility for clinical investigators about informed consent  The FDA is proposing to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants.
  November 13, 2018  
• AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) shows high virologic cure rates for naïve HCV  Enanta announced new data for AbbVie’s pan-genotypic chronic HCV treatment, MAVYRET™ (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results showed with 8 weeks of MAVYRET, 100 percent of genotype 1, 2, 4, 5 and 6 patients achieved a SVR12 per protocol analysis.
  November 13, 2018  
• 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  

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