Drugs
Based on favorable data and the recommendation of an independent data monitoring committee, Merck is stopping early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class III or IV at high risk of mortality. “In the study, WINREVAIR
Biologics
Neurogene is reporting that a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died following complications from a rare and life-threatening hyperinflammatory syndrome associated with systemic exposure to high doses of adeno-associated virus (AAV), the company says. Neurogene says FDA
Drugs
Endo is recalling (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength on the carton. An ongoing Endo investigation has identified the possibility that several clonazepam product lots contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC)
Drugs
FDA researchers have identified potential links between the widely prescribed asthma drug montelukast (Organon’s Singulair) and serious mental health issues, including depression and suicidal behavior, according to Reuters. FDA’s research findings, which are preliminary and have not been released publicly, were presented to a limited audience at the
Devices
ICU Medical has recalled (Class 1) its Plum Infusion Systems after receiving reports of allegedly counterfeit CSB Energy Technology batteries being used with the devices. “While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and
Biologics
FDA has granted Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Approval is based on data from the HERIZON-BTC-01 (NCT04466891) open-label, single-arm trial in 62 patients, according
Devices
FDA is publishing two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers. The first guidance, “Orthopedic Non-Spinal Bone Plates, Screws, and Washers — Premarket Notification (510(k)) Submissions,” provides recommendations for submissions involving non-resorbable bone plate, screw, and washer devices.
Devices
FDA has cleared a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center. The enhancements mean “expert radiologists can now assist technologists on-the-spot, by remotely controlling scans or adjusting protocols to acquire high-quality images needed for improved diagnostic
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review.” The document provides the agency’s current thinking regarding the alternative process for manufacturers to seek 510(k) submission reviews and EUAs. To view the
Devices
CDRH says a new device recall pilot program will look to improving communication timeliness about corrective actions being taken by companies on high-risk recall issues. “These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety
FDA Policy/General
Federal Register notice: FDA has determined that Renew Pharmaceuticals’ IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. IC-Green is indicated
Drugs
FDA says MXBBB has recalled one lot of Umary Acid Hyaluronic, 30 caplets 850 mg, to the consumer level. An agency notice says the product contains undeclared diclofenac and omeprazole, as confirmed by FDA laboratory analysis. Umary was distributed nationwide by Amazon, the notice says. It says MXBBB had not
Drugs
The more than 200 special agents working in the field for the FDA Office of Criminal Investigations (OCI) executed more than 290 arrests and achieved over 300 convictions in FY 2023. Writing in an FDA Voices post, assistant commissioner Justin Green, who heads OCI, says the group’s work “sends
Devices
While an FDA draft guidance on chemical analysis for biocompatibility assessment of medical devices is a “step in the right direction,” additional guidance is needed to address some of its “burdensome” recommendations. That’s the view of Adrienne Lenz, the principal medical device regulation expert at Hyman, Phelps & McNamara,
FDA Policy/General
Johns Hopkins surgeon and public policy researcher Marty Makary is reportedly on the shortlist to be nominated by president-elect Donald Trump as FDA commissioner under his new administration. Trump aids are offering words of caution that the pick is not final, according to a Bloomberg news report. “President-elect
Devices
Clinicians from several academic medical centers say litigation involving the Cook Celect inferior vena cava filter “demonstrates the need for greater transparency in medical device regulation,” especially involving 510(k) clearances. Writing in the Annals of Internal Medicine, the authors say (subscription or purchase required) regulatory reforms are necessary to
Devices
FDA says the Draeger 10/15 recall (correction) for its Atlan A350 and A350XL anesthesia workstations is Class 1. An agency notice says the company sent customers an urgent medical device correction indicating that a company representative would make contact to arrange for a ventilator motor assembly replacement. The notice
Devices
Smiths Medical is recalling (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potential issue where battery pack damage may lead to an electric short within the battery that melts the pack casing and stops the battery from being able to
FDA Policy/General
Federal Register notice: FDA has determined that Endo’s Fortesta (testosterone) gel, 10 mg/0.5 g, was not withdrawn due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Fortesta
Devices
FDA has published a guidance, 510(k) Third-Party Review Program and Third-Party Emergency Use Authorization (EUA) Review, with information on the two programs. The document says the guidance’s objectives are to: * describe and distinguish FDA’s expectations for the 3P510k review program and 3PEUA review; * the factors
FDA Policy/General
After a one-year implementation period, new FDA standards became effective 11/20 requiring drug marketers to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The five standards, outlined in an 11/20/2023 final rule entitled, “Direct-to-Consumer
Biologics
Sen. Ron Johnson (R-WI) has directed FDA, HHS, and CDC to “immediately preserve all records referring or relating to the development, safety, and efficacy of the Covid-19 vaccines.” In a statement (includes a link to the text of a letter to the agencies), Johnson says that under the