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Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
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Novartis announced new data demonstrating the early addition of twice-yearly* Leqvio® to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease, including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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A BioSpace survey found that 56% of employed and 81% of unemployed respondents are considering jobs outside biopharma. Some are also seriously thinking about leaving the U.S. to find employment in the field.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
Looking for a manufacturing job? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 data from BIO and TEConomy Partners. NCBiotech and Bexion executives discuss the area and the pros and cons of setting up shop far from major hubs.
Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”
The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.