Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.
A federal judge in Maine has put the brakes on a pilot program that would have enabled biopharma companies to offer rebates instead of up-front discounts as part of the 340B program beginning Jan. 1, 2026.
Pfizer Inc. has delivered on its threat of legal action against the attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., and has filed two lawsuits, one alleging breach of contract, and a second claiming that a merger of Novo Nordisk and Metsera would violate antitrust regulations.
Three years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. The amount is lower than the $3 billion in backpay Curevac could win through the lawsuit if a low mid-single-digit royalty were awarded, Evercore ISI analysts Jon Miller and Umer Raffat said. But the legal uncertainty has weighed heavily on the company, which shed 30% of its workforce last July and sold off rights to two of its infectious disease vaccines.
Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
The immediate implementation of the U.S. NIH’s guidance to cut indirect costs included in its grants to 15% was quickly halted late Feb. 10 when a federal district judge granted a nationwide temporary restraining order in two separate challenges to the cuts that were to go into effect that day on all existing and new NIH grants.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
