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Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
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After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
The Merck update, which will shed light on a $588 million bet to succeed Keytruda, is part of a roster of presentations that could shape the future of ADCs, protein degraders and KRAS-targeted therapies.
Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
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Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development.
For the second month in a row, job postings on BioSpace increased in key biopharma disciplines. However, application rates also increased.
Job listings in the area have ticked up in the last month. These seven companies are hiring in South San Francisco right now, including scientist and clinical roles.
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”
The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.