BioSpace News Archive

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  Policy

  NJ Federal Judge Skeptical of Pharma’s Challenge to IRA Drug Price Negotiations

  Judge Zahid Quraishi on Thursday appeared unconvinced by the pharmaceutical companies’ arguments that the Inflation Reduction Act’s Drug Price Negotiation Program violated the U.S. Constitution.

  March 8, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  Future of Amylyx’s ALS Drug in Question After Phase III Failure

  Friday’s topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.

  March 8, 2024

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  3 min read

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  Heather McKenzie
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  Policy

  Lilly’s Donanemab Hit with Surprise Delay, Set to Face FDA Adcomm

  The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.

  March 8, 2024

   · 

  3 min read

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  Tristan Manalac
• 

  Drug Development

  MindMed Gets Breakthrough Designation for LSD Candidate in Anxiety

  MindMed’s stock price jumped over 50% Thursday as its LSD-based candidate for generalized anxiety disorder got a breakthrough therapy designation from the FDA.

  March 8, 2024

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  2 min read

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  Tyler Patchen
• 

  Drug Development

  AstraZeneca, Sanofi’s Beyfortus 90% Effective at Preventing RSV Hospitalizations: CDC

  AstraZeneca and Sanofi’s respiratory syncytial virus immunizing antibody Beyfortus reached effectiveness of 90% against infection-related hospitalization in infants, according to the Centers for Disease Control and Prevention.

  March 8, 2024

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  2 min read

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  Tristan Manalac
• 

  Policy

  FDA Adcomm to Tackle Complexity of CAR-T for Multiple Myeloma

  BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.

  March 8, 2024

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  6 min read

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  Jill Neimark
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  Drug Development

  Merck KGaA Puts the Kibosh on BTK Inhibitor After Phase III MS Flops

  The company announced Thursday it terminated its BTK inhibitor evobrutinib for multiple sclerosis, which did not meet the primary endpoints in two late-stage trials.

  March 8, 2024

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  2 min read

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  Tyler Patchen
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  FDA

  BeiGene Secures Fifth Approval for Brukinsa, Expands into Follicular Lymphoma

  BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma.

  March 8, 2024

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  2 min read

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  Tristan Manalac
• 

  Policy

  Biden Turns Up Heat on Big Pharma’s Drug Prices in State of the Union Address

  President Biden called for expanding the Inflation Reduction Act to lower prescription drug prices. What would Trump do if he wins the 2024 election?

  March 8, 2024

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  5 min read

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  Greg Slabodkin
• 

  FDA

  Fresenius Kabi’s Biosimilar for Actemra Gets FDA Approval

  According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.

  March 8, 2024

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  2 min read

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  Tyler Patchen