Drug Development
Despite the definitive failure of Novo Nordisk’s semaglutide in Alzheimer’s, biotech executives, analysts and other industry experts see potential in more testing of GLP-1s for the neurodegenerative disease, particularly in a combination approach.
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In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
The R&D pipeline for depression therapies faced a demoralizing 2025 as five high-profile candidates, including KOR antagonists by Johnson & Johnson and Neumora Therapeutics, flunked late-stage clinical trials, underscoring the persistent challenges of CNS drug development.
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The Bay Area–based biotech plans to use the funds to advance two lead programs, one to treat atopic dermatitis and another for immune-mediated diseases.
As competition with Eli Lilly heats up, Novo Nordisk has partnered with Flagship’s Metaphore Biotechnologies to take a biomimicry approach to GLP-1s.
After a combination with Eisai’s Lenvima failed to improve survival in advanced disease in December, adjuvant Keytruda plus chemotherapy missed the mark in newly diagnosed, high-risk patients.
An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function.
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
While Teva missed Wall Street expectations in the first quarter of 2024, it reported Wednesday a 5% increase in Q1 revenues while reporting that the company’s schizophrenia candidate scored a late-stage trial victory
Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.