BioSpace News Archive

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  Drug Development

  Genentech Shows Off Positive Results From Phase III HEMLIBRA, TECENTRIQ Studies

  Data will be submitted to health authorities globally, including the FDA and EMA.

  November 20, 2017

   · 

  17 min read
• Drug Development

  resTORbio Advances to Part 2 of a Phase IIb Clinical Study of RTB101 Immunotherapy Following Unanimous Recommendation of Independent Data Monitoring Committee Overseeing the Study

  The Phase 2b clinical study is designed to assess the safety, tolerability and efficacy of 16 weeks of treatment with RTB101 alone or in combination with everolimus as compared to placebo in reducing the percentage of elderly individuals with respiratory tract infections.

  November 20, 2017

   · 

  3 min read
• Business

  Biohaven Receives Agreement From FDA on Initial Pediatric Study Plan for Rimegepant, a Second Generation Oral CGRP-Receptor Antagonist for the Acute Treatment of Migraine

  Agreement on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.

  November 20, 2017

   · 

  4 min read
• Drug Development

  Chugai’s Bispecific Antibody Emicizumab Meets Primary Endpoint in Phase lll Study

  No thrombotic events occurred in this study.

  November 20, 2017

   · 

  6 min read
• 

  Deals

  LivaNova Sells Its Cardiac Rhythm Management Biz to MicroPort for $190M Cash

  The CRM Business Franchise develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures.

  November 20, 2017

   · 

  11 min read
• BioMidwest

  RSNA Study: MRI Uncovers Brain Abnormalities in People with Depression and Anxiety

  Researchers using MRI have discovered a common pattern of structural abnormalities in the brains of people with depression and social anxiety, according to a study being presented next week at the annual meeting of the RSNA.

  November 20, 2017

   · 

  4 min read
• Business

  DiA Imaging Analysis Enters Partnership With GE Healthcare on Automatic Imaging Analysis Tools

  DiA Imaging Analysis, a medical imaging analysis software company, today announced that it has signed a multi-year, non-exclusive licensing and professional services agreement with GE Healthcare.

  November 20, 2017

   · 

  2 min read
• Business

  United Therapeutics Announces Additional Six Months of Regulatory Exclusivity for Adcirca

  United Therapeutics today announced that the FDA has granted pediatric exclusivity for Adcirca tablets through May 21, 2018, based on study results submitted by Lilly in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy.

  November 20, 2017

   · 

  6 min read
• Pharm Country

  Egalet Received a Grant from InnoBooster to Develop a Novel Application of Guardian Technology

  The grant provides non-dilutive funds to support the research project and will cover most of the external expenses needed to explore this opportunity into the pre-clinical stage of development.

  November 20, 2017

   · 

  5 min read
• 

  Business

  Gamida Cell Taps Former Clal Biotech CSO as New Leader

  Dr. Adams to further advance promising pipeline, including breakthrough therapy, NiCord, in phase 3 development as a universal bone marrow transplant solution.

  November 20, 2017

   · 

  3 min read