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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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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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Thursday, Gilead Sciences reported lower second-quarter profit due to a drop in sales of the company’s Veklury antiviral and a $525 million legal settlement, while slightly raising its sales outlook for the year.
The market opportunity for pulmonary arterial hypertension drugs stretches well beyond the 500–1,000 Americans diagnosed with the disease each year—and biopharma is taking note.
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.
A Louisiana woman has filed a lawsuit alleging that Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro did not have warnings about the risk of severe gastrointestinal problems.
During Regeneron’s second-quarter earnings call Thursday, the company said that the regulator could make its decision on 8-mg Eylea in the third quarter—much earlier than market expectations.
The biotech Thursday reported that second-quarter sales of its COVID shot dropped 94%. However, it expects $6 billion to $8 billion in revenue this year, up from a previous forecast of $5 billion.
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
Savings from just four of 10 drugs covered by the Inflation Reduction Act’s Drug Negotiation Program could reach $1.8 billion during the first year of implementation, according to research.