Drugs
Arrowhead Pharmaceuticals has agreed to acquire an FDA Rare Pediatric Disease Priority Review Voucher for $215 million from an undisclosed third party. The Pasadena, CA--based company says it intends to use the voucher for a supplemental NDA it plans to file before the end of the year to add
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for publishing a draft guidance on streamlining nonclinical safety studies for some oncology pharmaceuticals, particularly biologics and conjugated products. The association’s comment letter says issuance of the draft is a significant step toward implementing FDA’s Roadmap to
Drugs
A 1/12-1/16 FDA inspection at a Dabur India Limited drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/24 Warning Letter says the specific violations were: * failure to establish an adequate quality control unit with the responsibility and
Devices
A 2/2-2/6 FDA inspection at Koven Technologies in St. Louis, MO, found Quality Management System Regulation (QSMR) violations in the firm’s production and/or marketing of the Bidop 3 Doppler. A just-released 7/21 Warning Letter lists these violations: * failure to document procedures to control
Drugs
FDA says it is undertaking a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation tools, and a sharp increase in unannounced inspections of foreign manufacturing facilities, according to a new post by senior agency officials. FDA associate commissioner for inspections
Devices
FDA has issued an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices,” which describes current recommendations for applying human factors and usability engineering during the design and development of medical devices, revising a 2016 document to reflect changes in quality system requirements and current regulatory
Drugs
FDA has granted Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for the treating adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is described as an
Drugs
Sandoz has reached agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation alleging anticompetitive pricing practices in the generic drug market, while continuing to deny any wrongdoing. The company says its U.S. subsidiary has agreed to pay $400 million over
Drugs
FDA regulatory experts broadly praised the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug development but cautioned that lingering leadership turnover and regulatory uncertainty continue to weigh on investment in biotechnology, particularly in the cell and gene therapy sector. During the latest
Drugs
FDA has cited Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of its Rocklea, Queensland facility, according to a just-posted five-page Form FDA 483 issued at the close of the inspection. The inspection, conducted at the company's
Biologics
A new FDA draft guidance is outlining how sponsors should develop and evaluate container closure systems and device components used with biosimilar and interchangeable biosimilar products, providing a clearer framework for demonstrating that design differences from reference products do not compromise safety or effectiveness. The document focuses on therapeutic protein
Drugs
A new Harvard Law School legal commentary post argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged investment in drugs that offer limited clinical benefit while leaving important public health needs underserved. Legal scholars Daniel Aaron and Avery Emery contend that any debate over whether
Drugs
FDA has finalized a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems, providing updated recommendations intended to standardize studies supporting ANDAs for products such as patches and extended-release films. FDA says consistent adhesion is a critical quality attribute because the
Drugs
Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-stage study of patients with cardiovascular disease, chronic kidney disease and inflammation, marking a setback for the company's efforts to develop a new treatment targeting the
Drugs
FDA has issued a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritation and sensitization potential of transdermal and topical delivery systems submitted in ANDAs. The guidance provides recommendations for designing and conducting in vivo studies comparing proposed generic transdermal or topical delivery
Drugs
FDA has approved Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen- (PSMA) positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, broadening the radiopharmaceutical's use into an earlier stage of the
Biologics
Sen. Ron Johnson (R-WI), chairman of the Senate Permanent Subcommittee on Investigations, has requested that former CBER director Peter Marks, former CDER officials Narayan Nair, Steven Anderson, and Manette Niu, and former National Institute of Allergy and Infectious Diseases director Anthony Fauci appear for transcribed interviews about their roles
Biologics
FDA has accepted for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma. If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy
Drugs
FDA has cited contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice (CGMP) deficiencies following a 3/16-23 inspection of its Valley Cottage, NY facility, according to a just-posted Form FDA 483. The agency documented three observations, including repeat findings involving equipment cleaning and computerized systems
Drugs
A Friends of Cancer Research survey of eight drug companies with global oncology drug development programs determined that the U.S. excels at initial clinical trial site activation, but lags in scaling up site activation. The report says the first U.S. sites were activated a median of 124 days
Drugs
FDA has cited Gasco Industrial Corp. for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-counter drug manufacturing facility in Gurabo, Puerto Rico. The Form FDA 483 indicates the inspection was conducted as a follow-up to deficiencies previously identified
Drugs
FDA has classified a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associated with lidocaine ampules supplied as components in the kits. The action does not require removal of the kits from hospitals or other users, but instead instructs customers to remove and