Drugs
Leading health policy and regulatory experts are raising concerns over a new FDA review program that they say could politicize drug approvals and undermine scientific standards. The agency’s National Priority Voucher program is designed to accelerate FDA review times for certain drugs to as little as one to two
Drugs
FDA has posted a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis (PBC), following an FDA request that cited liver injury concerns. Last December, FDA issued a drug safety communication, saying its review of postmarket clinical
Devices
FDA has issued a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with the Bunnell LifePulse High Frequency Jet Ventilator and possibly other conventional ventilators. The agency warned that the problem can interrupt nitric oxide therapy and
Drugs
FDA has approved Merck’s checkpoint inhibitor pembrolizumab — administered as either Keytruda or the subcutaneous formulation Keytruda Qlex — in combination with Astellas and Pfizer’s antibody drug conjugate Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for adults with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin
Drugs
FDA has issued an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopri (cenobamate tablets). According to the just-posted letter, CDER Office of Prescription Drug Promotion (OPDP) determined that the TV ad, titled “Road to Reduction XCOPRI DTC
Devices
FDA says the 8/22 Medline recall of three models of sterile medicine convenience kits is Class 1. An agency notice says the company contacted five customers on 8/8, telling them to hold any kits in their possession. A formal recall notice followed on 8/22, the agency says.
Drugs
FDA has approved Regeneron Pharmaceuticals’ Eylea HD (aflibercept 8 mg) for treating macular edema following retinal vein occlusion (RVO), giving the drug a new indication that allows dosing as infrequently as every eight weeks after an initial monthly loading period. The agency also approved a monthly dosing option across all
Drugs
FDA has accepted for review a Nuvalent NDA for zidesamtinib, a next-generation ROS1-selective tyrosine kinase inhibitor (TKI) being developed for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) previously treated with at least one ROS1 TKI. The agency set a user fee
Drugs
An FDA 10/22 guidance, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, was issued to address some concerns raised about a 2017 guidance, especially about its relationship to requirements in the 21st Century Cures Act and the FDA Reauthorization Act of 2017. Attorneys Laura Dona and
Drugs
Sen. Tom Cotton (R-AR) is asking the Department of Justice to investigate and prosecute those who are responsible for “the surge in illicit counterfeit drugs and drug ingredients entering the United States from unregistered foreign entities, primarily in Communist China.” In an 11/19 letter to attorney general Pam
Drugs
Novartis is petitioning FDA to put restrictions on any ANDA or 505(b)(2) NDA citing Leqvio (inclisiran) as the reference-listed drug (RLD). The 11/18 petition says Leqvio is indicated as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia. It says Leqvio
Drugs
Texas attorney general Ken Paxton has reached a $41.5 million settlement with Pfizer and Tris Pharma after accusing the companies of providing adulterated ADHD medication to children enrolled in the state’s Medicaid program. The agreement resolves a lawsuit Paxton filed 11/2023, alleging that the companies knowingly distributed
Drugs
Sun Pharma Advanced Research Company (SPARC) says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after FDA the agency issued a complete response letter (CRL) tied to manufacturing deficiencies at a third-party supplier. The agency 7/2023-issued CRL cited inspection-related issues
Biologics
Based on information from two anonymous senior administration officials, Politico is reporting that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are embroiled in a feud over vaccine policy and agency personnel. The article provides additional insight into earlier reporting on Kennedy having discussed plans to scale
Drugs
FDA has issued a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered sweeping CGMP violations at the company’s active pharmaceutical ingredient (API) plant in Bangalore. The 11/13 letter follows an April inspection during which agency investigators documented extensive failures in Cdymax’s handling of out-
Drugs
Merck says its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heart–lung function in a mid-stage trial of patients with a rare and hard-to-treat form of pulmonary hypertension linked to heart failure with preserved ejection fraction (HFpEF). Topline data from the Phase 2 CADENCE
Drugs
FDA has released the form FDA-483 with eight observations from a 6/16-6/27 inspection at the NerPharMa drug manufacturing facility in Nerviano, Milan, Italy. The inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of
Drugs
Pharmaceutical Research and Manufacturers of America says FDA should revise its draft guidance on implementing the safety labeling changes (SLCs) provision included in the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act to promote an efficient and rational regulatory process, and based on
Drugs
Sens. Chris Coons (D-DE) and Ted Budd (R-NC) have introduced the Biomanufacturing Excellence Act that they say would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. A statement (includes links to the bill text and a one-page summary) from Coons says the legislation would
Drugs
FDA has launched a new pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug developers. Announced 11/19 by FDA commissioner Marty Makary, the initiative creates a streamlined process for companies to get rapid clarification on specific points in their official
Devices
Siemens Healthineers has issued an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastrophic failure involving the systems’ magnet venting pathways. The alert covers many of the company’s high-field MRI systems, including MAGNETOM Verio, Skyra, Prisma, Vida, Lumina,
Devices
Aesculap Implant Systems has agreed to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee replacement implants and provided unlawful kickbacks to a surgeon. The Pennsylvania-based medical device company also entered into a non-prosecution agreement for distributing two