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The new structure will help Merck as it slides toward a loss of exclusivity for Keytruda, pharma’s best-selling drug.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Vocal skeptics of COVID-19 vaccinations gave mRNA a bad name and government funding for mRNA research is now being cut. On the flip side, at least one CEO said the pandemic also provided “elevated acceleration” for the field, which also holds promise in therapeutics for cancer and rare diseases.
As the World Health Organization initiates a new agreement for coordinating global responses to future pandemics, the future of vaccine development in the U.S. faces growing challenges, including waning funding and regulatory changes, that threaten next-gen COVID-19 vaccine candidates and pandemic preparedness more broadly.
Beginning this week in Chicago, the American Association for Cancer Research’s annual conference will feature presentations that could have far-reaching implications for breast and blood cancers and more.
The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases.
In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.
Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the first-line setting for this indication.
The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.
The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”
The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.
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.