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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.
THE LATEST
Seeking a potential slice of the challenging KRAS market, Merck has launched a Phase III NSCLC trial of its oral G12C inhibitor MK-1084, in combination with Keytruda, in pursuit of Amgen and Bristol Myers Squibb.
Following clearer overall survival data from the PSMAfore trial, Novartis on Thursday affirmed plans to file for a prostate cancer label expansion for its targeted radioligand therapy Pluvicto later this year.
Due to slow uptake of its Humira biosimilar Cyltezo in the U.S., Boehringer Ingelheim is laying off an undisclosed number of its sales employees, Reuters reported on Thursday.
Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.
Amid a flurry of deals in the antibody-drug conjugate space, Merck KGaA is getting in on the action with a partnership with Caris Life Sciences to accelerate the discovery and development of first-in-class ADCs for oncology.
Following disappointing late-stage data, Amylyx on Thursday said it is withdrawing the company’s amyotrophic lateral sclerosis drug Relyvrio from the U.S. and Canadian markets and cutting its workforce by approximately 70%.
Three Biopharma firms disclosed concerns about how emerging geopolitical tensions between the U.S. and China might impact their business with the contract manufacturer.
A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.
Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Congress and the Biden administration have set their sights on lowering prescription drug costs.