Eli Lilly’s investigational obesity pill helped lower weight and blood sugar in patients with obesity and type 2 diabetes, but the Phase 3 results may not be enough to assuage concerns about the competitiveness of the drug. The medication, called orforglipron, is the most advanced small-molecule GLP-1 in development. Treatment with the drug led to…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hey, good morning. Today, we see CBER suspend the license for a chikungunya vaccine, look at a push to recall a safety and efficacy study for the antidepressant Paxil, and more. FDA pulls license for…
WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. “People who navigate the government’s clunky adverse event reporting websites should not…
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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. The Supreme Court is allowing the Trump administration to cut $783 million in research grants tied to DEI work. Also, STAT just unveiled its special report on the 2025 rankings of the…
Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s acquisition of Catalent, one of the largest contract manufacturers serving the pharmaceutical industry. A copy of a Food…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see fallout from the FDA’s rejection of Replimune’s melanoma drug affecting another biotech, learn how Sarepta’s decision-making has affected a patient population that hasn’t always been in the headlines, and more. As Sarepta…
The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks. The move comes after protracted uncertainty surrounding…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We learned yesterday that Walmart has recalled some of its frozen shrimp after the FDA warned that they may have been contaminated with radioactive material. This news prompted a lively debate in…
Allison DeAngelis is the East Coast biotech and venture capital reporter at STAT, reporting where scientific ideas and money meet. She is also co-host of the weekly biotech podcast, The Readout Loud. You can reach Allison on Signal at AllisonDeAngelis.01. Former Food and Drug Administration Commissioner Stephen Hahn is taking the top spot at a …
