BioSpace News Archive

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• 

  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
• 

  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
• 

  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
• 

  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 as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General.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
• Press Releases

  Zymeworks Announces Participation in Upcoming Investor Conferences - November 21, 2024

  November 22, 2024

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  3 min read
• Press Releases

  Updated Phase 2 OraGrowtH Data Presented at ESPE 2024 Demonstrate Sustained Growth on Oral LUM-201 to 24 Months in PGHD and Correlation of Growth to LUM-201’s Unique Pulsatile Mechanism of Action

  November 22, 2024

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  7 min read
• Press Releases

  Xenetic Biosciences, Inc. Presents Positive Preclinical Data Highlighting the Potential of Co-Administration of DNase I with CAR T Cells in a Murine Model of Melanoma Lung Metastasis

  November 22, 2024

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  7 min read
• Press Releases

  NYU Langone Performs World’s First Fully Robotic Double Lung Transplant

  November 22, 2024

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  5 min read
• Press Releases

  Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway

  November 22, 2024

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  4 min read
• Press Releases

  CAMP4 Reports Third Quarter 2024 Financial Results

  November 22, 2024

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  10 min read