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
Drugs
CNBC TV-18, India’s leading business television station, says Cyberabad cyber crime police have arrested two individuals who were accused of running an extortion and cyber-intimidation racket targeting Hetero Drugs. The station says a Hetero senior employee reported receiving emails demanding a $250 million ransom. Police said the
Drugs
FDA has approved Genmab’s Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymphoma (FL), expanding treatment options for one of the most common indolent B-cell lymphomas. The agency action also converted the drug’s 2024 accelerated approval for third-line
Drugs
A 6/25-7/12 FDA Bioresearch Monitoring Program inspection at Verdure Sciences in Noblesville, IN, found that the company failed to submit an IND as the sponsor of a clinical investigation of its investigational drug Maplifa. An 11/10 Warning Letter says the company indicated it did not believe
Drugs
FDA has approved an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that can trigger life-threatening pancreatitis. Redemplo is approved as an adjunct to a very low-fat diet for adults with FCS, a
Drugs
Roche says its investigational selective estrogen receptor degrader (SERD) giredestrant significantly improved invasive disease-free survival in people with early-stage, ER-positive/HER2-negative breast cancer, marking the first time an oral SERD has shown superiority to standard endocrine therapy in the adjuvant setting. The Phase 3 lidERA trial