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Madrigal will study SYH2086 in combination with Rezdiffra for metabolic dysfunction-associated steatohepatitis, aiming for clinical trials in early 2026.
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Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
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Daiichi Sankyo and AstraZeneca’s Biologics License Application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.
Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.
Minovia’s lead product is MNV-201, an autologous hematopoietic stem cell product that is enriched with allogeneic mitochondria.
Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.
Without providing further context, HHS Secretary Robert F. Kennedy Jr. says that Gavi needs to “start taking vaccine safety seriously” by considering “the best science available.”
Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
Given today’s available local talent pool, biopharma companies are less likely to turn toward international job candidates, according to a talent acquisition expert. Findings from two recent BioSpace LinkedIn polls underscore the issue.
Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval of Novavax’s COVID-19 vaccine could indicate a politicization of the drug approval processes that could ‘imperil public health.’
Are long R&D cycles, overwhelming literature reviews, or patent bottlenecks slowing your path to innovation? In the fast-evolving life science landscape, AI is no longer a luxury, it’s a necessity.
The seven new members of the CDC’s influential Advisory Committee on Immunization Practices recommended Merck’s new anti-RSV monoclonal antibody, discussed mRNA vaccine technology while injecting misinformation into the debate, heard updates on the upcoming flu season and, finally, voted to remove thimerosal from all flu vaccines.