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.
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.
After a five-year court battle in which Gilead Sciences Inc. scored several victories only to have the U.S. government appeal, Gilead has reached a settlement with the Department of Health and Human Services and the Department of Justice to resolve government claims that the company had infringed its patents covering the pre-exposure prophylaxis (PrEP) use of two Gilead HIV drugs.
Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution that was signed into law Dec. 21 to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain.
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
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