BioSpace News Archive

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• 

  Vaccines

  5 Late-Stage mRNA Vaccines to Watch

  The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.

  September 16, 2024

   · 

  5 min read

   · 

  Ben Hargreaves
• 

  FDA

  FDA Action Alert: BMS, Merck, Sanofi/Regeneron and More

  The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.

  September 16, 2024

   · 

  6 min read

   · 

  Tristan Manalac
• 

  Bladder cancer

  AstraZeneca’s Perioperative Imfinzi ‘Significantly Extends Survival’ in Type of Bladder Cancer

  The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
  
  

  September 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  ALS

  The HEALEY Platform Trial: Quick Failures and New Hope for ALS

  Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.

  September 16, 2024

   · 

  10 min read

   · 

  Heather McKenzie
• 

  Lung cancer

  GSK, iTeos Score Phase II Win for Jemperli-TIGIT Combo in NSCLC

  High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.

  September 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Phase III

  BMS Finds More Than 40% Survival Rate for Melanoma Combo Therapy at 10 Years

  Bristol Myers Squibb presented the positive Phase III results on its already approved Opdivo-Yervoy combo at ESMO over the weekend, while separately announcing that it was returning Immatics’ bispecific T cell engager.

  September 16, 2024

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  1 min read

   · 

  Annalee Armstrong
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  Approvals

  Lilly Secures FDA Nod for Eczema Therapy, Eyes Launch in ‘Coming Weeks’

  Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.

  September 16, 2024

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  2 min read

   · 

  Tristan Manalac
• Press Releases

  Sarepta Therapeutics Appoints Deirdre Connelly to its Board of Directors

  September 16, 2024

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  4 min read
• Press Releases

  Exelixis Announces Final Results from Phase 3 Pivotal CABINET Study Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2024 and Published in New England Journal of Medicine

  September 16, 2024

   · 

  19 min read
• FDA

  T2 Biosystems Receives FDA Clearance to Market the T2Candida Panel for Pediatric Patients

  September 16, 2024

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  6 min read