BioSpace News Archive

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• 

  FDA

  FDA Approves First Treatment for Severe Frostbite, Reduces Risk of Amputation

  Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.

  February 15, 2024

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  2 min read

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  Tristan Manalac
• 

  Policy

  FDA Action Alert: Alvotech and Minerva

  In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.

  February 15, 2024

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  3 min read

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  Tristan Manalac
• 

  Business

  ADC-Focused Firefly Bio Emerges from Stealth with $94M Series A

  Co-founded by Nobel Prize winner Carolyn Bertozzi, Firefly’s venture funding is backed by Eli Lilly and Versant Ventures, among others, to support its novel platform for merging antibody-drug conjugates with protein degraders.

  February 15, 2024

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  2 min read

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  Tyler Patchen
• 

  Business

  Sage Touts Strong Launch for Postpartum Depression Drug Zurzuvae

  Despite missing out on an FDA approval for major depressive disorder, Zurzuvae appears to be a strong asset for Sage Therapeutics, with high growth potential in 2024.

  February 15, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  Sanofi Gets Phase II MS Win, Eyes $5B in Peak Annual Sales for Pipeline

  The French drugmaker Thursday touted trial results in The New England Journal of Medicine showing frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis.

  February 15, 2024

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  2 min read

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  Nick Paul Taylor
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  Drug Development

  Otsuka’s Longer-Acting Schizophrenia Injection to Offset Abilify Patent Loss

  A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.

  February 15, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  Roche-Backed Freenome Continues Industry’s Funding Rally with $254M Raise

  Freenome announced Thursday a fundraising round of more than a quarter of a billion dollars, led by Roche, to advance its blood-based cancer tests as pivotal readouts approach.

  February 15, 2024

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  2 min read

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  Tristan Manalac
• Drug Development

  Osivax Announces Vaccination of First Participant in First-in-Human Trial Evaluating Sarbecovirus Vaccine Candidate OVX033

  Osivax announced that the first participant has been vaccinated in its new Phase 1 trial evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate.

  February 15, 2024

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  4 min read
• Biotech Beach

  MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza®

  MannKind Corporation announced that it has fully enrolled 305 patients living with type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population.

  February 15, 2024

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  4 min read
• Biotech Bay

  Freenome Raises $254 Million in New Funding to Accelerate its Platform for Early Cancer Detection

  Freenome, a biotechnology company developing blood tests for early cancer detection, announced the addition of $254 million from new and existing investors.

  February 15, 2024

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  4 min read