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In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will support the future launch of the pharma’s own kidney disease asset, currently in multiple Phase 3 trials.
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The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Accumulating scientific evidence and industry interest from Eli Lilly, Altimmune and startup Baseline Therapeutics is driving further research on the therapeutic potential of GLP-1 receptor agonists in treating substance use disorders.
At the AD/PD annual meeting, Eisai presented real-world data suggesting Leqembi’s long-term safety and efficacy in people homozygous for APOE4, who were identified in trials as being at higher risk of brain bleeds while on the treatment. Alzheon, meanwhile, added further detail to trial results of its candidate in patients with the same genetic profile.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
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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.
In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.
Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called dysesthesia, has emerged in the late-stage TRIUMPH-4 trial.
The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.