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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?
THE LATEST
Biopharma professionals aren’t typically hired right away, based on a BioSpace LinkedIn poll. In the past year, only about one-third of respondents found employment in three months or less. Several who did share their keys to success.
In a volatile industry, staying put might seem like a smart bet, but job hugging can quietly erode your visibility, growth and future opportunities.
Sheila Gujrathi, former CEO of Gossamer Bio, has written a new book that aims to offer the type of leadership manual she never had in her early career.
The startup, launched out of CEO Kevin Parker’s grad school idyll during the COVID lockdowns, is primed to find new targets where Big Pharmas won’t dare.
Reporting third quarter earnings on Tuesday, Johnson & Johnson CEO Joaquin Duato said the healthcare giant has not yet secured a drug pricing deal with the White House, but discussions are ongoing.
Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q3 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
J&J reports today, just two weeks after Pfizer secured certainty on tariffs and drug pricing. Analysts expect to hear about plans from the rest of the industry during third period earnings calls.
Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.