The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.
The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.
The U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals.
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
Erasca Inc. has obtained IND clearance by the FDA for ERAS-4001, an oral selective pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors.
RSS
