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The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
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With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.
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Moderna, Inc. announced it has been notified by the U.S. Food and Drug Administration that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application for mRNA-1345, Moderna’s investigational respiratory syncytial virus vaccine, by the previously communicated Prescription Drug User Fee Act date of May 12, 2024.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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BMS is letting go of 68 employees in Lawrenceville, New Jersey. The pharma has now cut over 1,000 employees there since April 2024 as part of its cost-cutting measures.
The rise of monoclonal antibodies brought back hope for stalling or reversing the devastating neurodegenerative disease. Big Pharma has taken notice with a handful of high-value deals, GlobalData reports.
Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation.
In an open letter addressing the Trump administration’s proposed budget cuts to HHS, the executives urged Congress to continue “robust federal funding” for scientific research, which they say will help maintain U.S. biotech leadership globally.
In adults 50 and older, Moderna’s flu shot was more than 26% better than an unspecified commercial vaccine. In May, the company pulled its application for a combo flu/COVID-19 shot, saying it would refile following data from this Phase III trial.
As of Apr. 22, Sage had 338 full-time employees, all of whom will be laid off effective Aug. 22. The layoffs were announced a few weeks after Maryland’s Supernus Pharmaceuticals acquired Sage for up to $795 million.
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside experts.
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month.
The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.