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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.
FROM OUR EDITORS
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
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
The combination of Keytruda and an mRNA vaccine reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years in a Phase IIb study.
The Biden administration on Thursday said 48 drugs covered under Medicare’s Part B may be subject to inflation rebates in the first quarter of 2024 under the Inflation Reduction Act.
What needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen.
The U.S. Supreme Court has agreed to the Biden administration’s request to review lower-court rulings that would curtail access to the abortion pill mifepristone, with a decision expected in the summer.
After a “reasonably strong year” in 2023, next year will see “similar levels” of M&A activity with increased investor interest in weight loss and cardiovascular diseases, contends professional services firm PwC.
If approved by the FDA, the MDMA-assisted treatment for individuals with post-traumatic stress disorder would be the first U.S. psychedelic-assisted therapy.
A resume should communicate to employers that a candidate has what they are looking for by highlighting technical and soft skills.
Here’s what to look for—and what to ask—before and during the interview process to find out whether an employer fosters an inclusive environment.
Preparation is key to ensuring one stands out in an increasingly competitive job market. We asked an expert for tips.