It’s official. A year after President Donald Trump issued an order requiring the U.S. to withdraw from the World Health Organization (WHO), that withdrawal has been completed.
Shionogi & Co. Ltd. and Fosun Pharmaceutical (Group) Co. Ltd. were involved in separate divestment transactions this week, with Shionogi buying out Pfizer Inc.’s stake in Viiv Healthcare Ltd. to lift its holding to 21.7%.
Citing the “totality of data,” Sanofi SA plans to file global regulatory submissions this year for amlitelimab in atopic dermatitis, despite mixed results from two additional phase III trials testing the OX40-ligand (OX40L) inhibitor the pharma firm has been positioning as a potential successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster, Dupixent (dupilumab).
The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency.
On the heels of more positive early data from the lead program derived from its tumor-activated T-cell engager (TRACTr) platform, Janux Therapeutics Inc. inked a collaboration with Bristol Myers Squibb Co. that comes with $50 million in up-front and near-term milestone payments, with the possibility of up to $800 million more tied to development, regulatory and commercial milestones.
Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.
Erasca Inc. priced an upsized public offering to raise $225 million to fund development of its therapies for patients with RAS/MAPK pathway-driven cancers.
The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said.
In a move that could dramatically shorten some clinical development timelines for drugs targeting multiple myeloma, the U.S. FDA issued a draft guidance on the potential use of minimal residual disease and complete response to support accelerated approvals, following the recommendation of the agency’s Oncologic Drugs Advisory Committee, which voted 12-0 in favor of the change in April 2024.
Another day, another insider trading settlement involving a biopharma company employee. This time the U.S. SEC settlement is with Mohit Verma, who was a researcher and associate director of immunology at the San Diego-based Infinitybio Inc. at the time of the alleged violative trading activity.
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