BioSpace News Archive

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  Genetown

  FDA Briefing Documents in CNS Space Have Investors Jittery

  Lately, there has been heightened attention to briefing documents in the CNS space, a notoriously tricky area to get drugs approved, which can affect company stock prices.

  March 29, 2022

   · 

  5 min read

   · 

  Mark Terry
• 

  Drug Development

  Clene Could be Big Part of “Momentous Year” for ALS Research

  Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.

  March 29, 2022

   · 

  4 min read

   · 

  Alex Keown
• 

  Drug Development

  ImmunoGen Ovarian Cancer Drug Reaches BLA Milestone

  When ImmunoGen announced top-line results from the Phase III SORAYA trial in November 2021, the primary endpoint - confirmed objective response rate - was met at 32.4%.

  March 29, 2022

   · 

  3 min read

   · 

  Hannah Chudleigh
• 

  Business

  Sanofi Commits Potential $6B to IGM (Antibodies) in New Collab

  Sanofi and IGM Biosciences inked a collaboration deal for oncology, immunology and inflammation that could surpass $6 billion.

  March 29, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Antares, Lipocine, Finally Get Approval for Testosterone Replacement Therapy

  Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).

  March 29, 2022

   · 

  2 min read

   · 

  Hayley Shasteen
• 

  Business

  BioSpace Movers & Shakers, April 1

  It’s a new month and a new chapter for several life sciences executives. Here’s a look at some notable Movers & Shakers beginning April with new companies.

  March 29, 2022

   · 

  7 min read

   · 

  Alex Keown
• 

  Drug Development

  Pfizer’s S1P Therapy Scores Second Phase III Win in Ulcerative Colitis

  Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.

  March 29, 2022

   · 

  2 min read

   · 

  Hayley Shasteen
• 

  Drug Development

  Taysha, Prothena, Pipeline and Neuroplast Launch Clinical Trials

  Four companies, Pipeline Therapeutics, Prothena, Neuroplast, and Taysha Gene Therapies, announced launches of clinical trials in the CNS space.

  March 29, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  In Cardio Breakthrough, Researchers Prevent Clogged Arteries with Chaperone Mediated Autophagy

  New research investigates the role chaperone-mediated autophagy (CMA) can play in preventing atherosclerosis, a thickening or hardening of the arteries.

  March 29, 2022

   · 

  2 min read

   · 

  Jazmine Colatriano
• 

  FDA

  Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus

  Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.

  March 29, 2022

   · 

  3 min read

   · 

  Mark Terry