Drugs
FDA has approved Ionis Pharmaceuticals’ Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). The company says Tryngolza is the first FDA approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in acute
FDA Policy/General
The FDA Center for Veterinary Medicine (CVM) says its evaluation of adverse events reported in dogs of various ages treated with Zoetis’ Librela (bedinvetmab injection) found ataxia; seizures; other neurologic signs including paresis, recumbency, urinary incontinence, polyuria, and polydipsia. A CVM statement says Librela, a monoclonal antibody drug used to
Drugs
Axsome Therapeutics says it will submit an NDA for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimer’s disease agitation despite reporting mixed Phase 3 clinical trial data. The investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor has previously been granted
Drugs
Novo Nordisk has petitioned FDA to exclude its liraglutide from the agency’s list of bulk drug substances that may be used by outsourcing facilities in compounding. Liraglutide is a GLP-1 agonist and is the active ingredient in the company’s diabetes drugs Victoza and Xultophy and weight-loss
Drugs
FDA has released a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility. A 6/14-6/26/2024 inspection found multiple violations, including significant GMP issues for finished drugs. Some specific violations were: * failure to establish
Drugs
FDA has approved Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. An agency notice says efficacy was established in Study CK-301-101 in 109 patients. The major outcome measures
Drugs
FDA has approved Xcovery Holding’s Ensacove (ensartinib) for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. An agency statement says efficacy was evaluated in the eXALT3 trial in 290 patients who were randomized
Devices
FDA has approved Humacyte Global’s Symvess (acellular tissue engineered vessel-tyod) indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and autologous vein graft is not feasible. An agency statement says Symvess is the first
Drugs
FDA says its laboratory analysis of Rhino 11 gummies found the presence of tadalafil (Lilly’s Cialis) that is not listed on the product label. An agency notice says the product is promoted and sold for sexual enhancement on various Web sites and possibly in some retail stores. The notice
Devices
FDA says there is a potential need for early device replacement of Boston Scientific’s Accolade pacemakers. An agency safety communication says the company recalled a subset of Accolade pacemaker devices with an increased risk of permanently entering Safety Mode, which has limited functionality and has been associated with the
Drugs
A 4/11-4/18/2024 FDA inspection at the Micro Orgo Chem drug manufacturing facility in Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 12/3/2024 Warning Letter says the specific violations were: * failure to adequately validate written
Drugs
FDA has released a draft guidance entitled “Considerations for Complying With 21 CFR 211.110” that describes how to comply with batch uniformity and drug product integrity requirements. In addition, it discusses related quality considerations for drug products that are manufactured using advanced manufacturing, and how manufacturers can incorporate process
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Advanced Manufacturing Technologies (AMT) Designation Program.” The document provides recommendations on participating in the program, which facilitates the development of drugs manufactured using a designated AMT. To view the notice, click here.
Drugs
Chimerix has submitted an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma. The submission is based on Phase 3 clinical trial data showing that dordaviprone had an objective response rate of 28%, a median duration of response of 10.4
FDA Policy/General
Federal Register notice: FDA is announcing a 5/15 public meeting entitled “Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act” to seek input from interested parties concerning pediatric drug and biologic development and labeling. The input is intended to help the agency prepare a legislatively
FDA Policy/General
Following 52 years of service at CDER, senior advisor for clinical science Bob Temple has retired effective 12/31. Additionally, effective 12/31 FDA principal deputy commissioner Namandjé Bumpus, the agency’s second-in-command, has left the agency in advance of the new incoming presidential administration. Temple joins CDER
Biologics
Xbrane Biopharma has resubmitted a BLA for its investigational ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor therapy that prevents vision loss
Devices
FDA has issued a safety alert on Nuwellis’ AquaFlexFlow UF 500 Plus extracorporeal blood circuit, which is used with the Aquadex SmartFlow and FlexFlow Systems, because the device may trigger a “weight mismatch” alarm while in use. “If too many weight mismatch alarms occur, the Aquadex console will terminate therapy
Drugs
Sens. John Hickenlooper (D-CO), Tom Cotton (R-AR), Peter Welch (D-VT), and Susan Collins (R-ME) have introduced legislation intended to lower drug prices by accelerating the rollout of generic drugs and creating legal protections from lawsuits from manufacturers who obtain FDA “skinny label” approvals. A statement from
Devices
FDA says the Hologic 3/13/2024 recall correction of BioZorb Markers was Class 1. An agency statement says the company updated the recall 10/25/2024 to remove all lots of the BioZorb markers. The single-use implantable radiographic marker is used to mark soft tissue, such as breast
Drugs
UCB says the ORCHESTRA Phase 2a proof-of-concept study of minzasolmin did not meet its primary and secondary clinical endpoints. The drug is described as an investigational, oral small molecule, alpha-synuclein misfolding inhibitor that was being developed with Novartis to treat early Parkinson’s disease. A company statement
Devices
FDA has issued an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide clamps. “If a solution set with an inverted slide clamp is loaded on an infusion pump, the medication may not be delivered and the patient’