Drugs
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging FDA to revise and clarify its draft guidance on using quantitative systems pharmacology (QSP) models to select starting doses in first-in-human clinical trials, arguing that the document should better align with international standards while providing greater flexibility for
Drugs
FDA issued a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, India, citing significant quality system deficiencies, including failures to adequately investigate out-of-specification (OOS) and out-of-trend (OOT) test results.
Drugs
FDA has released 17 revised draft product-specific guidances (PSGs) for peptide products, which it touts as a “significant advancement in the agency’s scientific and regulatory approach to generic peptide drug assessment.” The revised draft PSGs address the following peptide products: * Calcitonin salmon (Calcimar, NDA 017769) * Calcitonin salmon (Miacalcin,
Drugs
Novo Nordisk has filed a motion for a preliminary injunction in the New Jersey District Court, seeking to stop Eli Lilly's “misleading” GLP-1 advertising campaigns while an earlier Novo Nordisk lawsuit proceeds. The move follows Novo Nordisk's lawsuit last week (see story) alleging that ads
Biologics
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well before a BLA filing to help avoid delays and common regulatory pitfalls. According to a just posted transcript, officials from CBER's Office of
Drugs
FDA has issued a final guidance encouraging sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performance status, arguing that less restrictive enrollment could make study populations more representative of patients treated in routine clinical practice. The guidance, “Cancer Clinical Trial Eligibility Criteria: Performance
Drugs
An FDA briefing document released ahead of a 7/29 Cellular, Tissue, and Gene Therapies Advisory Committee meeting reviewing Capricor Therapeutics’ resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystrophy (DMD) says the company’s Phase 3 HOPE-3 study failed to meet its pre-specified primary
Drugs
FDA has issued a final guidance encouraging cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications, arguing that unnecessarily restrictive requirements can slow patient enrollment and limit the applicability of trial results to real-world populations. The guidance, “Cancer Clinical Trial Eligibility
Drugs
A final FDA guidance is urging sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to patient participation while maintaining appropriate safety protections. The agency said overly restrictive laboratory requirements can limit enrollment, reduce trial diversity, and make study results less representative of
Drugs
FDA is announcing an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug (IND) Pilot Program, an initiative designed to shorten the time between drug discovery and the start of first-in-human clinical trials. The one-hour webinar (9:00 a.
FDA Policy/General
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A Bulks List for pharmacy compounding, setting up a significant policy decision for the agency amid an ongoing debate over the safety and clinical evidence supporting
Drugs
Amgen has submitted to FDA new scientific data and analyses in its bid to prevent the withdrawal of Tavneos (avacopan), arguing that the treatment continues to demonstrate a favorable benefit-risk profile for patients with severe active ANCA-associated vasculitis (AAV), a rare and potentially life-threatening autoimmune disease. The
Drugs
FDA has issued a Complete Response Letter (CRL) to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combination product, seeking an indication for use in adults as adjunctive therapy for treating peptic ulcers by reducing the amount of acid produced.The
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus), following reports that the arterial sheath tip can separate during use. The agency said
Drugs
FDA has issued a Form 483 to Bausch + Lomb following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL, identifying multiple observations involving complaint investigations, aseptic manufacturing practices, environmental monitoring, and quality system controls. One observation focused on complaint handling. FDA investigators
Drugs
FDA has published a strategy document on facilitating Chemistry, Manufacturing, and Controls (CMC) readiness for products with accelerated clinical development. The document says its publication completes the four CMC items the agency agreed to do under PDUFA 7. The strategy document says FDA: * published a CDER Manual of Policies and
Drugs
Bringing the keynote address at the Society of Cardiovascular Computed Tomography’s annual meeting, former FDA commissioner Rob Califf warned that efforts need to be made if the nation’s overall population health outcomes are to improve. He said the U.S. faces a troubling paradox in which revolutionary advances
Drugs
The Senate HELP Committee has voted unanimously to advance legislation sponsored by Sen. Rand Paul (R-KY) to streamline the biosimilar approval process. A statement issued by Paul says the Expedited Access to Biosimilars Act would increase market competition, lower drug prices, and increase access to more life-saving treatments.
Drugs
FDA has cited SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical method validation, study documentation and adherence to standard operating procedures at the company's Saint-Benoît, France, facility. According to a just-posted three-page Form FDA 483, investigators documented four inspectional
Biologics
Johnson & Johnson is reporting positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqyv) plus Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey plus pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received
Drugs
Lilly says its investigational first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist retatrutide met its primary endpoint in the Class 3 TRIUMPH-2 and TRIUMPH-3 studies, delivering substantial weight loss in adults with obesity complicated by type 2 diabetes and established cardiovascular disease. The company
Drugs
Advocacy group Public Citizen has filed a petition urging FDA to ban prescription drug direct-to-consumer (DTC) advertising. Such a prohibition would “align U.S. policy with international best practices, protect the public from misleading and harmful drug promotion, and promote rational, evidence-based prescribing,” the group contends. “DTC