Drugs
FDA has released the form FDA-483 with six observations from a 6/23-7/14 inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN. FDA gave an “Official Action Indicated (OAI)” classification to the inspection that could delay the approval and production timelines for drug products,
Drugs
FDA has cited PharmaTher over alleged misleading promotional claims for its generic ketamine. An agency review found the company’s Web page omitted required risk information about the drug product. It also claimed the generic ketamine was approved “for surgical pain management” or “pain and surgery management,” language that deviates
Drugs
Novo Nordisk says data from two global Phase 3 trials, evoke and evoke+, of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with early-stage symptomatic Alzheimer’s disease over two years. The trials enrolled 3,808 people aged 55 to 85 with mild cognitive impairment
Drugs
U.S. House and Senate health committee leaders are voicing concern about a new FDA review pilot program because it appears designed to enable corruption and reward President Trump’s allies with faster drug approvals. In an 11/20 letter to FDA commissioner Marty Makary, House Energy and Commerce Committee
Drugs
FDA investigators have cited Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-control deficiencies after a two-week inspection uncovered gaps in aseptic processing, environmental monitoring, and product quality review. Inspectors from the agency’s New Jersey District Office visited the facility between
Drugs
Johnson & Johnson has decided to discontinue its Auτonomy Phase 2b Alzheimer’s study after interim data showed its experimental antibody posdinemab failed to produce a statistically significant benefit in slowing the clinical decline of early-stage Alzheimer’s disease. The company described the trial — which it billed as a
Drugs
Former FDA principal deputy commissioner Janet Woodcock and policy experts from Duke University are calling on the agency to adopt new tools and pathways to support evidence-based drug repurposing, arguing that the current system — built around commercial drug sponsors — prevents many proven new uses of generic medicines from ever
Drugs
FDA investigators have cited Immacule Lifesciences Private Limited, a sterile drug contract manufacturer in Himachal Pradesh, India, for extensive lapses in aseptic manufacturing, equipment design, environmental monitoring, and contamination prevention during a 10-day inspection in September. The findings are detailed in a just-posted lengthy FDA Form 483. Investigators
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
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
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
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