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The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Read our takes on the biggest stories happening in the industry.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs.
Now in Phase III with its small molecule orforglipron, Eli Lilly is leading the oral GLP-1 race against Novo Nordisk, Pfizer, Roche and others.
Altimmune on Wednesday said it is ending development of HepTcell, a hepatitis B candidate, following disappointing trial results as it focuses on obesity and metabolic dysfunction-associated steatohepatitis.
The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United States. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patients.
As the Biden administration calls for more-expansive drug pricing controls, it’s important to reflect on how we’re arriving at expected outcomes.
Stoke Therapeutics plans to offer up more than 5.5 million shares of its common stock following positive Phase I/IIa data for its Dravet syndrome candidate.
Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.