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Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
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Read our takes on the biggest stories happening in the industry.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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The deal is a blast from the not-too-distant past, when special purpose acquisition companies were an easy way for companies to list on the public market with a bundle of cash to operate on.
Roche’s Genentech is betting on the Flagship Pioneering–founded company’s discovery platform called DECODE to find new targets for an undisclosed autoimmune disorder.
The so-called ‘Most Favored Nations’ rule would set drug pricing for Medicare in line with the prices paid by other nations, where drugs can be much cheaper.
Analysts at BMO Capital Markets expect Summit and Akeso’s HARMONi-6 readout to put some pressure on Merck and its blockbuster biologic Keytruda.
Just raising the alarm won’t drive action. Use these three steps to turn insights into solutions that leadership can’t ignore.
Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.
Bausch Health has launched a shareholder rights plan—also known as a poison pill defense—designed to prevent any one entity from taking control of the company to the detriment of other shareholders.
Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.