After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
Two former Spero Therapeutics Inc. executives are on the hook for a total of $187,500 in civil penalties in a settlement resolving U.S. SEC allegations of issuing misleading statements centered on the FDA’s evaluation of Spero’s lead drug candidate that resulted in a 64% stock drop in May 2022.
The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.
A biostatistician who was consulting for C4 Therapeutics Inc. is facing civil and criminal charges of U.S. securities fraud related to insider trading that allegedly produced nearly $500,000 in profit.
The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
U.S. President Donald Trump unveiled his “Great Healthcare Plan” Jan. 15, an initiative he said would slash prescription drug prices, maximize price transparency in the health care system and hold big insurance companies accountable.
Years after approving three glucagon-like peptide-1 (GLP-1) receptor agonists to treat obesity, the U.S. FDA is acknowledging that the drugs don’t have the same risk seen with older weight-loss medicines. Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs – Eli Lilly and Co.’s Zepbound (tirzepatide) and Novo Nordisk A/S’ Saxenda (liraglutide) and Wegovy (semaglutide).
Abbvie Inc. announced its agreement to focus on improving access and lowering the cost of medicines, becoming the latest pharma to fall in line with the Trump administration’s most-favored nation (MFN) pricing deal. Regeneron Pharmaceuticals Inc. now remains the only firm originally included in President Donald Trump’s July 31 MFN ultimatum that has yet to finalize terms.
U.S. Health and Human Services Secretary Robert Kennedy has once again expanded the CDC’s Advisory Committee on Immunization Practices (ACIP), this time adding two more ob-gyns to the membership list. As a result, the ACIP, which can have up to 19 members, now numbers 13, three of whom are ob-gyns.
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