BioSpace News Archive

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  Pharm Country

  J&J Highlight Massive Q2 Earnings While Covid Vaccine Doubts Grow and Legal Battles Rage

  As Johnson & Johnson touted $23.3 billion sales on its Q2 earnings call this morning, other news in the media hasn’t been as kind to the massive, global conglomerate.

  July 21, 2021

   · 

  3 min read

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  Kate Goodwin
• 

  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
• 

  FDA

  Magenta Down After FDA Places Clinical Hold on IND for AML/MDS Drug

  The FDA placed a clinical hold on Magenta’s clinical program for acute myeloid leukemia and myelodysplastic syndrome, which made its shares drop nearly 7% this morning.

  July 21, 2021

   · 

  2 min read

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  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
• 

  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
• 

  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
• 

  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
• 

  Drug Development

  FDA Gives OK for Viracta’s Phase Ib/II Trial of Oral Combo in Epstein-Barr Virus Tumors

  The study will also investigate the oral combination with PD-1 inhibitor pembrolizumab in EBV+ metastatic nasopharyngeal carcinoma (RM-NPC).

  July 21, 2021

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  3 min read

   · 

  Brandon May
• 

  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

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  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