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Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.
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Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.”
Sales of Amgen’s thyroid eye disease drug Tepezza have slowed, dipping 1% to $457 million in the fourth quarter of 2025.
If the Trump administration’s proposal passes, the FDA’s budget will be more than $200 million bigger in 2027, with plans to launch new programs that expedite drug development, boost national security and promote “radical transparency.”
While an acquisition is a good exit for Soleno Therapeutics, the company’s acceptance of Neurocrine Biosciences’ $53-per-share offer came as a surprise to Stifel analysts given the potential growth of Vykat XR, approved last year for extreme hunger in patients with Prader-Willi syndrome.
Some disease areas bucked the trend of shrinking pipelines, however, with immune and cardiovascular indications seeing an upward trend in investigational assets.
Anthropic in October last year iterated its Claude AI model to better cater to biopharma purposes. Sanofi, Novo Nordisk, AbbVie and others already use Claude in their operations.
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.