Devices
FDA has approved an expanded use for Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system, allowing implantation of a new Evolut valve inside any previously implanted transcatheter aortic valve that has failed. The action broadens treatment options for patients with severe aortic stenosis or other valve failure who are
Devices
Ambu is recalling (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional. “This defect can lead to an increased risk of harm caused by pressure changes (barotrauma) and delayed ventilation, since the ventilation pressure applied with Ambu SPUR
Devices
Hamilton Medical is recalling (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit. “The inner blue limb delivers fresh gas to
Biologics
FDA has approved an Eisai/Biogen at-home injection option for Alzheimer’s treatment Leqembi (lecanemab), expanding access to patients in the early stages of the disease. The approval covers Leqembi Iqlik, a once-weekly subcutaneous autoinjector of lecanemab for maintenance dosing. Patients who have completed the 18-month initiation
Drugs
FDA has approved a Foresee Pharmaceuticals NDA for Camcevi ETM (leuprolide mesylate), a once every three months injectable formulation for treating advanced prostate cancer. The drug was previously approved for six-month dosing. The approval was based on data from a Phase 3 study involving 144 patients with advanced prostate
Drugs
An FDA review of a Web site maintained by Platinum Biologics of Orlando, FL, determined that the company sells two umbilical cord-derived products and two exosome products, all for allogenic use. An 8/15 Warning Letter says the four products are unapproved new drugs and unlicensed biological products. The
Drugs
FDA has issued Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix (89Zr-DFO-girentuximab), an investigational positron emission tomography (PET) imaging agent designed to help diagnose and characterize clear cell renal cell carcinoma. The letter cited deficiencies in the drug’s chemistry, manufacturing, and controls
Drugs
FDA has rejected Outlook Therapeutics’ resubmitted BLA for Lytenava (bevacizumab-vikg), a proposed treatment for wet age-related macular degeneration (wet AMD), citing insufficient evidence of effectiveness. In a complete response letter issued this week, the agency said it could not approve the application in its current form because the
Drugs
AdventaPharma is asking FDA not to approve any ANDA using Novo Nordisk’s Ozempic (semaglutide injection) as the reference-listed drug unless two conditions are met. The 8/26 petition says FDA should require that: * the generic drug/device combination product includes a pen injector that is functionally equivalent to
Drugs
FDA has accepted a Bayer NDA for gadoquatrane, a next-generation gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). The submission seeks approval for contrast-enhanced MRI of the central nervous system and other body regions in adults and children, including newborns. If approved, gadoquatrane would
Biologics
In the wake of CDC director Susan Monarez’s ouster, Senator Bill Cassidy (R-LA), who is chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is calling on HHS to postpone a just-announced Advisory Committee on Immunization Practices (ACIP) meeting that is scheduled to review the
Drugs
FDA is recommending an additional, earlier MRI monitoring scan before the third infusion of Eisai/Biogen’s Leqembi (lecanemab) for Alzheimer’s disease patients. An agency statement says the earlier monitoring “can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or
Drugs
FDA has released the form FDA-483 issued following a 7/15-7/25 inspection at IntegraDose Compounding Services, a Minneapolis, MN, outsourcing facility. The form’s six inspection observations were: * failure to write and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure
Devices
Integra LifeSciences is recalling (Class 1) its Extended Tip Applicators because the products may have high levels of harmful substances and may not have gone through a fully documented sterilization process. “Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a recall notice
Drugs
Amylyx Pharmaceuticals says it will discontinue development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in progressive supranuclear palsy (PSP) after the drug failed to show benefit in a mid-stage clinical trial. The Phase 2b ORION study found no differences between AMX0035 and placebo on primary or secondary
Devices
FDA has issued an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed from where they are used or sold. The company stated that affected devices have a pump driver circuit assembly that does not meet current specifications. “These pump
Drugs
BioXcel Therapeutics says its pivotal Phase 3 SERENITY At-Home trial met its main safety endpoint, supporting a planned supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL501) for unsupervised use in patients with bipolar disorders or schizophrenia. The 12-week, placebo-controlled study evaluated BioXcel’
Biologics
An FDA review of the Web site maintained by Innate Healthcare Institute in Scottsdale, AZ, found that the company markets “umbilical cord mesenchymal stem cells” for allogenic use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure
Devices
A 1/27-1/30 FDA inspection at the Uscom Kft facility in Budapest, Hungary, determined that the company is illegally manufacturing and marketing several spirometers for which it does not have an approved PMA or IDE in effect. A just-released 7/30 Warning Letter also lists these Quality
Drugs
FDA has released the form FDA-483 issued following a 7/28-8/9 inspection at Hikma Injectables USA, Inc., a Dayton, NJ, outsourcing facility. The four inspection observations were: * failure to establish written procedures for production and process controls designed to assure that the drug products have the identity,
Drugs
In a letter to FDA organized by the UCLA Law Center on Reproductive Health, Law, and Policy and Advancing New Standards in Reproductive Health at the University of California, San Francisco, more than 260 reproductive health researchers nationwide affirm the 25-year safety record of the medication abortion drug mifepristone
Drugs
FDA says the CDER Office of New Drugs has accepted an Echosens Letter of Intent to qualify Liver Stiffness Measurement by Vibation-Controlled Transient Elastography as a reasonably likely surrogate endpoint for clinical trials in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis.