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Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.
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Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil.
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Speaking on the sidelines of the J.P. Morgan Healthcare Conference, Novo business development executive Tamara Darsow said the company is gunning for obesity and diabetes assets.
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It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
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The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
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.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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 loss of domvanalimab is the latest in a string of high-profile failures recorded across the biopharma world for the TIGIT modality, including from GSK, Merck and Roche.
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.