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Home » Topics » Regulatory » Courts

Courts
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New admin toes the Biden line on Rx price negotiations

Feb. 25, 2025
By Mari Serebrov
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
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Dollar sign dropper and test tube

Court orders full stop to US NIH slashing of indirect rates

Feb. 11, 2025
By Mari Serebrov
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.
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FDA website and logo

Doctors group sues US CDC, FDA, HHS over data takedown

Feb. 5, 2025
By Mari Serebrov
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.
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Novo Nordisk to appeals court: Hurry up, please, on IRA challenge

Jan. 31, 2025
By Mari Serebrov
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.
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Biohaven’s pre-acquisition deeds lead to $60M payout for Pfizer

Jan. 27, 2025
By Mari Serebrov
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.
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Gavel and pill blister packs

US Claims Court rules Vanda’s trade secrets not so secret

Jan. 24, 2025
By Mari Serebrov
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.
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Generic drugs and bottle

Drugsplaining: Teva details price negotiation impact on generics

Jan. 22, 2025
By Mari Serebrov
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.
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Gilead, US end court battle over HIV PrEP patents

Jan. 16, 2025
By Mari Serebrov
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.
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Biontech’s $1.26B vaccine royalty settlement clears path forward

Dec. 30, 2024
By Mari Serebrov
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.
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Year in review 2024 - US lawsuits

Year’s top US court cases to present new challenges for 2025

Dec. 24, 2024
By Mari Serebrov
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.
Read More
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