BioSpace News Archive

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• 

  IPO

  3 Biotechs Seek Over $700M in Renewed IPO Rush

  Bicara Therapeutics, Zenas BioPharma and MBX Biosciences are seeking a combined $700 million-plus in IPO filings this week.

  September 13, 2024

   · 

  2 min read

   · 

  Annalee Armstrong
• 

  Approvals

  Roche Gains PD-1 Edge on Merck With FDA Nod for Subcutaneous Tecentriq

  Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.

  September 13, 2024

   · 

  2 min read

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  Tristan Manalac
• 

  Editorial

  BIOSECURE Act Targets China but Fails to Address Fallout for US Biopharma

  It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.

  September 13, 2024

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  4 min read

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  Greg Slabodkin
• 

  Neuropsychiatric disorders

  Neurocrine Scraps Schizophrenia Candidate After Phase II Failure

  BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward.

  September 13, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Layoffs

  Oncternal to Lay Off 37% of Employees, Including CMO

  Oncternal Therapeutics will lay off about 10 workers as it explores “strategic alternatives” that could include asset sales or an M&A.

  September 13, 2024

   · 

  1 min read

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  Angela Gabriel
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  Infectious disease

  Gilead Touts 96% HIV Risk Reduction With Twice-Yearly PrEP, Eyes Regulatory Filings

  Armed with readouts from the PURPOSE 1 and 2 trials, Gilead Sciences is now gearing up for global regulatory submissions for lenacapavir as a pre-exposure prophylactic option for human immunodeficiency virus.

  September 13, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  Facing ‘Daunting’ Launch Schedule, Moderna to Slash $4B in R&D Spend by 2028

  Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.

  September 13, 2024

   · 

  4 min read

   · 

  Annalee Armstrong
• 

  FDA

  Astellas’ Hot Flash Drug Veozah Slapped With Another FDA Warning for Liver Injury

  One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label.

  September 13, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• Press Releases

  Tr1X to Participate at Upcoming Healthcare Investment Conferences

  September 13, 2024

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  1 min read
• Press Releases

  Yale School of Medicine recognized by NIH for excellence in genetics of rare diseases

  September 13, 2024

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  2 min read