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Gilead underscored its faith in the combo therapy and pledged to work with regulators to resolve the hold, which has paused five clinical trials. Gilead also stressed that the hold does not impact any other assets in its HIV pipeline.
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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.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
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Scenic Biotech announced that it has entered into a research collaboration with Bristol Myers Squibb to accelerate the development of Bristol Myers Squibb’s drug targets by identifying target biology for indication selection and expansion.
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Belrestotug showed underwhelming efficacy outcomes in mid-stage studies of non-small cell lung cancer and head and neck squamous cell carcinoma.
Roche envisions its Indianapolis site as a “major hub” for the manufacturing of its continuous glucose monitoring systems. The news comes on the heels of an announced $700 million investment in North Carolina.
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.
Meanwhile, Bayer CEO Bill Anderson said Donald Trump’s Most Favored Nations policy could present an opportunity for European countries to make sure they are also funding their “fair share” of biopharma innovation.
The commitment is part of Roche’s recently announced $50 billion investment in the U.S., but a company spokesperson said that could change if certain yet-unspecified policies are implemented that could “harm our industry’s ability to operate and innovate in America.”
The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.
The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
Azafaros will use the Series B haul to push lead asset nizubaglustat into late-stage studies for Niemann-Pick disease Type C and GM1/GM2 gangliosidoses later this year.