Hemispherian AS has received IND clearance for GLIX-1 for the treatment of glioblastoma from the U.S. FDA. GLIX-1 targets DNA repair mechanisms, specifically the enzyme TET2, selectively in tumor cells while sparing healthy tissues.
Purespring Therapeutics Ltd. has received the go-ahead for a phase I/II trial of its investigational gene therapy PS-002 from both the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the National Health Service Health Research Authority and Research Ethics Committee.
Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.
The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.
The other shoe dropped on the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) when at least nine liaison organizations were informed by email late July 31 that they would no longer be involved in ACIP’s process of reviewing scientific evidence and informing vaccine recommendations.
While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.
Mabwell (Shanghai) Bioscience Co. Ltd. announced that its Cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC), 7MW-4911, has received IND clearance to initiate clinical trials from both the U.S. FDA and China's National Medical Products Administration (NMPA).
The U.S. Department of Justice announced July 31 that Illumina Inc. agreed to pay $9.8 million to settle allegations it sold genomic sequencing equipment that suffered from cybersecurity problems. The settlement concludes a qui tam lawsuit filed by a former employee and highlights the hazards of poor cybersecurity for med-tech firms.
Regeneron Pharmaceuticals Inc. disclosed within a positive second-quarter earnings report that it had received a complete response letter (CRL) two days earlier from the U.S. FDA for its bispecific antibody, odronextamab, for relapsed/refractory follicular lymphoma following two or more lines of systemic therapy.
With the U.S. FDA’s approval of Lenz Therapeutics Inc.’s Vizz (aceclidine ophthalmic solution), there is a third eye drop on the market for treating presbyopia. Vizz, however, is the first aceclidine-based eye drop for adults.
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