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
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  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
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  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

  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
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  FDA

  BMS Wins FDA Approval for Opdivo in First-line Bladder Cancer

  The approval, which Bristol Myers Squibb reported on Thursday, positions the company to compete with Astellas and Pfizer’s Padcev.

  March 8, 2024

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  2 min read

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  Nick Paul Taylor
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  FDA

  FDA Approves Novo’s Obesity Drug Wegovy to Reduce Cardiovascular Events

  Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight.

  March 8, 2024

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  2 min read

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  Tyler Patchen
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  Drug Development

  Deep Dive: Leqembi and the Future of Alzheimer’s Treatment

  In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.

  March 8, 2024

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  3 min read

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  Heather McKenzie
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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
• 

  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