The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”

China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.

The U.S. FDA has made clear its expectations of batteries and accessories for automated external defibrillators, but at least one maker of replacement AED batteries seems to have not got the message.

The U.S. Environmental Protection Agency’s rulings on ethylene oxide emissions have drawn the ire of the device industry, but the chemical industry has weighed in as well.

Insignis Therapeutics Inc.’s sublingual anaphylaxis treatment IN-001 has received Fast Track designation from the FDA. The Fast Track program is designed to expedite the product review and facilitate the development of drugs that treat serious conditions and address unmet medical needs.

Cidara Therapeutics Inc. announced in its Q2 filing that it received IND clearance for its drug-Fc conjugate (DFC) immunotherapy CBO-421 in July of 2024.

Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).

The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.

The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.

With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.