BioSpace News Archive

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  Drug Development

  Genentech’s Combo Therapy for Rare Blood Cancers Scores Breakthrough Designation

  Genentech announced that the FDA has green-lit the Venclexta classification and azicitidine combination as a Breakthrough Therapy Drug.

  July 21, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Global Roundup: England’s Calyx Establishes US Toehold in North Carolina

  Biopharma companies from around the globe provide updates on their businesses and pipelines.

  July 21, 2021

   · 

  6 min read

   · 

  Alex Keown
• 

  Business

  Money on the Move: July 14 – 21

  More money means more progress for potentially life-saving therapies. Here’s a peek at some biopharma companies adding to their books this week.

  July 21, 2021

   · 

  5 min read

   · 

  Kate Goodwin
• 

  Study: Transplant From Mother’s Gut May Reverse Newborns’ Risk for Type 1 Diabetes

  Researchers say transplanting fecal microbiota from the mother into the newborn can reverse the risk for Type 1 diabetes for babies who had been exposed to antibiotic treatments early.

  July 21, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Policy

  Biogen’s Aduhelm: Slow to Launch with Controversy Continuing

  Biogen’s Aduhelm was approved on June 7, 2021, for Alzheimer’s patients, and the controversy continues to grow.

  July 21, 2021

   · 

  6 min read

   · 

  Mark Terry
• 

  Business

  Biogen Ties Up with Mirimus for Neurological Indications, and Other Collaborations

  Mirimus and Biogen, AavantiBio and Aldevron, Exscientia and GT Apeiron Therapeutics announced strategic partnerships this morning.

  July 21, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  FDA

  FDA Grants Breakthrough Device Designations to Endologix and NeuroMetrix

  The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.

  July 21, 2021

   · 

  2 min read

   · 

  Brandon May
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  Policy

  Koselugo: The First Non-Surgical Alternative for Rare Plexiform Neurofibroma

  Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.

  July 21, 2021

   · 

  5 min read

   · 

  Heather McKenzie
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  Genetown

  Albireo Breaks New Ground with Approvals for First Drug Bylvay in PFIC

  It will immediately begin to sell Bylvay to treat patients impacted by PFIC, a rare cholestatic liver disease that often leads to cirrhosis and liver failure within the first ten years of life.

  July 21, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Genetown

  Novartis Delivers Strong Second Quarter and 50 Million CureVac Vaccines

  The company also reported on its COVID-19 vaccine production with CureVac, a drug it is abandoning, and a few specific drug updates.

  July 21, 2021

   · 

  3 min read

   · 

  Mark Terry