Drugs
FDA has lifted a partial clinical hold on Avidity Biosciences’ delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for use in treating myotonic dystrophy Type 1. The investigational treatment is “designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no
Drugs
FDA has released the form FDA-483 issued following a 6/25-7/3 inspection at the BSO outsourcing facility in Lakewood, CO. The five inspection observations were: * failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization
Drugs
FDA has released a list of 18 drug products for which there was a potential signal of serious risks or new safety information during the second quarter of 2024. FDA says it is evaluating the need for regulatory action for 17 of the products. It reports that for the 18th,
Drugs
FDA has granted Amphix Bio a breakthrough device designation for its supramolecular peptide amphiphiles-based drug-device combination product for bone regeneration. The designation applies to the product’s use to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures, according to the company. “The moldability of the
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery, for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Drugs
FDA has denied a 12/21/2018 Amneal Pharmaceuticals petition asking it to (1) change the therapeutic equivalence code published in the Orange Book for all strengths of Provell’s Euthyrox (levothyroxine sodium) tablets from AB2 to BX to mitigate the risk of look-alike medication errors and (2) refuse
Drugs
Aldeyra Therapeutics has resubmitted an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms of dry eye disease. The resubmission “includes previously disclosed positive results from a recently complete dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA,
Drugs
The Combination Products Coalition (CPC) says FDA should change its draft guidance on essential drug delivery outputs (EDDOs) for devices intended to deliver drugs and biological products to offer companies greater flexibility in determining how to implement the concepts in the guidance. “In particular,” the coalition comment letter says, “we
Drugs
FDA has released the form FDA-483 issued following an 8/26-9/6 inspection at the Annovex Pharma outsourcing facility in Lorton, VA. The seven inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic
Drugs
FDA has approved GE HealthCare’s Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging (PET MPI) agent for detecting coronary artery disease. The imaging agency is designed to deliver higher diagnostic efficacy compared to single-photon emission computed tomography MPI, which is the standard currently used
Drugs
The journal Science and other FDA watchers are indirectly putting pressure on FDA to place a clinical hold on an ongoing Phase 3 clinical trial of Cassava Sciences’ invrestigational Alzheimer’s drug simufilam following a recent $40 million settlement with the U.S. Securities and Exchange Commission (SEC) related to
Drugs
FDA has given fast-track designation to Volastra Therapeutics’ VLS-1488, an internally discovered KIF18A inhibitor to treat patients with platinum-resistant high-grade serous ovarian cancer. A company statement says a Phase 1/2 trial is evaluating the safety, tolerability, and preliminary efficacy in patients with advanced tumors, including
Biologics
FDA has published a guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, with help for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, new animal drugs,
Drugs
FDA has released the form FDA-483 issued following a 7/15-8/2 inspection at ProRx, an Exton, PA, outsourcing facility. The 13 inspection observations were: * failure to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile; * failure to include adequate validation
Drugs
Sen. Bill Cassidy (R-LA) is asking FDA to explain why it has failed to provide clarity to drug manufacturers on properly listing their products’ patents in the Orange Book. In a 9/30 letter to FDA commissioner Robert Califf, Cassidy says that for decades, brand and generic drug manufacturers
Drugs
A 5/6-5/16 FDA inspection at the Diamond Chemical Co. drug manufacturing facility in East Rutherford, NJ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/6 Warning Letter says specific violations were: * failure to test samples of each component
Drugs
Following four fatalities, Kezar Life Sciences has suspended the enrollment of new patients and dosing of ongoing patients in its Phase 2b PALIZADE trial evaluating two dose levels of zetomipzomib (30mg and 60mg) in patients with active lupus nephritis. The suspension resulted from a safety data review by an independent
Drugs
Smiths Medical has recalled (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob movement. “When the knob is set at high (1,000 – 1,500 ml) or low (70 - 150 ml), the knob may move away from the original setting on its
Drugs
FDA has granted a de novo marketing clearance for Germitec’s Chronos automated disinfection device for reducing the risk of cross-contamination. The one-button, chemical-free automated device uses UV-C technology to “penetrate the membrane of microorganisms, disrupting their DNA, RNA, and cellular proteins, thereby halting their replication
Drugs
FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Approval is based on data from two landmark pivotal Phase 3 studies (BOREAS and NOTUS) that evaluated the efficacy and safety
Drugs
FDA has approved Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults. The approval marks a major shift in treating the condition as Cobenfy is the first drug to target cholinergic receptors, rather than dopamine receptors, which have long been the standard of care
Drugs
An investigational Parkinson’s drug under development by Prothena is being called into question because of falsified research publication allegations centered around one of NIH’s top officials. An investigation by the journal Science raises issues with research conducted and published over the past two decades by NIH neuroscientist Eliezer