Drugs
A 3/2-3/6 FDA inspection at the Fresenius Medical Care North America drug manufacturing facility in Ogden, UT, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/25 Warning Letter says the two specific violations were: * failure to thoroughly investigate any unexplained
Devices
FDA has added a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has found no evidence that certain PFAS materials widely used in medical equipment are harming patients. The agency said its review of scientific literature and post-
Drugs
Novartis and Bristol Myers Squibb have each paused some studies of CAR T candidates while adverse events are evaluated. BioSpace reports Novartis suspended multiple studies of its rapcabtagene autoleucel (rap-cel) after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome. Meanwhile, the
enforcement
A 2/23-3/6 FDA inspection at Jabil Inc.’s Pharmaceutics International drug manufacturing facility in Cockeysville, MD, found significant violations of current good practice (CGMP) regulations for finished drugs. An 8/27 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy or
Drugs
A 2/19-2/27 FDA inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/18 Warning Letter says the specific violations were: * failure to ensure that laboratory
Drugs
Clear rules are needed for when FDA decides to publicly release complete response letters (CRL), according to a new analysis published in the Journal of Law and the Biosciences. The CRL postings, which were launched under former FDA commissioner Marty Makary as part of a broader “radical transparency” effort, are
Drugs
FDA and the International Coalition of Medicines Regulatory Authorities (ICMRA) have completed an assessment of a new biologics testing approach that could reduce use of horseshoe crab blood while continuing to ensure product quality. The assessment is part of the ICMRA Collaborative Assessment Pilot, which brings participating international regulators together
Drugs
The Washington, DC Court of Appeals appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandated approval deadline. In Norwich Pharmaceuticals Inc. v. Kennedy, the court ruled that a first generic applicant can avoid forfeiting its exclusivity for missing
FDA Policy/General
FDA and the U.S. Securities and Exchange Commission have agreed to strengthen cooperation and share information involving companies and products regulated by the agency. Under a new three-year memorandum of understanding, the agencies will establish procedures for exchanging both public and certain non-public information when it is
Drugs
Karyopharm Therapeutics has submitted a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with myelofibrosis. Karyopharm has requested a priority review, which, if granted, could result in a six-month review. The sNDA is based, in part, on data from the Phase 3 SENTRY
Drugs
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) and its use in extensive stage small cell lung cancer (ES-SCLC). IDEAYA is planning
Drugs
FDA has approved Priovant Therapeutics’ Lisraya (brepocitinib) tablets for treating dermatomyositis in adults. “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases,” FDA says in a release. “Dermatomyositis is a rare autoimmune disease in which the
Drugs
FDA’s approval of new drugs is increasingly being supported by fewer clinical studies, while industry-sponsored research represents a much larger share of the evidence behind those approvals, according to a new analysis published in PLOS One. Researchers from Stanford University, Oregon State University, UCLA and other institutions looked
FDA Policy/General
FDA has cited Alar Pharmaceuticals over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly portrayed the unapproved drug as safe and effective for treatment-resistant depression. A just-posted 8/21 untitled letter from CDER Office of Prescription Drug Promotion (OPDP) says the materials were on
Biologics
FDA has approved updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season. The vaccines are formulated to better match the XFG variant currently in circulation. The updated vaccines include Moderna's Spikevax and mNEXSPIKE, Pfizer-BioNTech's Comirnaty and Novavax-Sanofi&
Drugs
FDA has approved Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with Type 2 diabetes who are at high risk for such events. The dual GIP and GLP-1
Devices
FDA has issued an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold because of a manufacturing issue affecting the catheter tip. The devices are used to create images of specific
Drugs
A new report from Senate HELP chair Bill Cassidy (R-LA) is criticizing FDA for allowing the abortion drug mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) to remain in place without requiring sponsors to conduct meaningful oversight of prescribing patterns. The report, released following a committee investigation, examined the
FDA Policy/General
FDA’s intensified scrutiny of drug advertising is extending beyond direct-to-consumer (DTC) television and radio spots, with lawyers alerting companies to prepare for closer examination of promotional claims, supporting data, social-media content and the use of artificial intelligence. The agency’s is approaching the one-year anniversary
Devices
A MasterControl analysis of the first months of medical device inspections under the new FDA Quality Management System Regulation (QMSR) found that agency investigators are “uncovering interconnected problems that span a company’s entire quality system.” A MasterControl statement says the investigators are increasingly finding that complaint-handling deficiencies, corrective
Drugs
Three Akin Gump attorneys say the PDUFA 8 commitment letter released by FDA earlier this month details performance goals and procedures across six areas of focus: (1) ensuring the effectiveness of the human drug review program; (2) continued enhancement of user fee resource management; (3) transparency in FDA hiring and
Drugs
So far, every court that has been presented with a Loper Bright argument against preemption in a product liability case has rejected it, according to attorney James Beck (Reed Smith). Writing in a Drug & Device Law online post, Beck says the courts have recognized that Loper Bright (1) only