BioSpace News Archive

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• 

  Dan Samorodnitsky

  January 13, 2025
• 

  Dan Samorodnitsky

  Dan Samorodnitsky is the news editor at BioSpace. You can reach him at dan.samorodnitsky@biospace.com.
• 

  Regulatory

  Keytruda and Opdivo Scrutiny Highlights FDA’s Evolving Biomarker Focus

  An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.

  January 13, 2025

   · 

  5 min read

   · 

  Kate Goodwin
• 

  Mergers & acquisitions

  Johnson & Johnson Makes Major Neuro Play With $14.6B Intra-Cellular Buyout

  Among Intra-Cellular’s neuropsychiatric assets is Caplyta, a pill approved for schizophrenia and bipolar depression and proposed for major depressive disorder.

  January 13, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Neuroscience

  Biogen Submits Offer to Buy Embattled Partner Sage

  Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%.

  January 13, 2025

   · 

  3 min read

   · 

  Heather McKenzie
• 

  Antibody-drug conjugates

  Merus and Biohaven Strike New ADC Collaboration

  On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.

  January 13, 2025

   · 

  1 min read

   · 

  Dan Samorodnitsky
• 

  Neuropsychiatric disorders

  AbbVie Absorbs $3.5B Cost of Schizophrenia Flop

  Emraclidine was the centerpiece of AbbVie’s $8.7 billion acquisition of Cerevel in December 2023 but failed two mid-stage trials. Tavapadon, meanwhile, has been a more rewarding asset for the pharma, clearing three Phase III Parkinson’s studies in 2024.

  January 13, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  IPO

  Metsera Moves Fast in Crowded Obesity Market With IPO Plans

  Metsera will use its IPO proceeds to fund the Phase III development of its injectable, ultra-long-acting GLP-1 therapy MET-097i, which last week achieved 11.3% weight loss in a Phase IIa study.

  January 13, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Layoffs

  Passage Bio Cutting 55% of Staff to Help Extend Cash Runway

  Passage Bio’s workforce reduction could affect about 32 people, leaving the company with 26 employees as it continues evaluating a treatment for frontotemporal dementia with granulin mutations.

  January 13, 2025

   · 

  1 min read

   · 

  Angela Gabriel
• 

  Gene therapy

  5 Cardio Gene Therapies on the Near Horizon

  Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.

  January 13, 2025

   · 

  9 min read

   · 

  Tristan Manalac