BioSpace News Archive

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• 

  Postmarket research

  Merck’s Former Asthma Blockbuster Singulair Could Be Linked to Mental Health Problems: Reuters

  A Reuters report on Friday revealed that FDA researchers have found additional molecular evidence tying blockbuster asthma therapy montelukast to adverse neuropsychiatric effects.

  November 22, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Adcomms

  AstraZeneca Fends Off Adcomm’s Safety Concerns on Andexxa, Axes Mid-Stage Opioid Use Disorder Drug

  The pharma is seeking full approval for its anticoagulation reversal drug Andexxa, which the FDA granted accelerated approval in 2018 for patients who had been treated with apixaban or rivaroxaban.

  November 22, 2024

   · 

  3 min read

   · 

  Tristan Manalac
• 

  Editorial

  Trump’s ‘Team of Self Promoters’ Will Make for Great Reality TV but an Uncertain Biopharma Environment

  RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.

  November 22, 2024

   · 

  6 min read

   · 

  Jef Akst
• 

  Gene therapy

  Patient Death in Rett Syndrome Trial Forces Neurogene to Drop High-Dose Arm

  Despite the death, the FDA has allowed Neurogene to forge ahead with the Phase I/II Rett syndrome trial, but using only the lower 1E15 vg dose of its investigational gene therapy NGN-401.

  November 22, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• Press Releases

  Novotech Publishes Comprehensive Report on the Global Vaccine Clinical Trials Landscape

  November 22, 2024

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  2 min read
• Press Releases

  BioSurfaces Receives $2.06 Million Grant to Advance Development of Bio-Spun™ Cell Chamber Device

  November 22, 2024

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  3 min read
• Press Releases

  ENDRA Life Sciences Regains Compliance with Nasdaq Minimum Bid Price Requirement

  November 22, 2024

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  3 min read
• Press Releases

  Indaptus Therapeutics, Inc. Announces $2.135 Million Registered Direct Offering and Concurrent Private Placement

  November 22, 2024

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  4 min read
• Press Releases

  Aptevo Highlights the Potential of the Company’s Robust Portfolio in Cancer Immunotherapy, the Success of Bispecifics as a Category, and Their Growing Importance in the Oncology Treatment Paradigm

  November 22, 2024

   · 

  10 min read
• Press Releases

  Critical Care Therapeutics Industry Opportunities by Drug Class and Application with Regional Market Breakdowns, 2025-2030: Integration of AI and ML in Drug Development Offers Untapped Opportunities

  November 22, 2024

   · 

  5 min read