EIRs/483s
FDA has granted Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nephropathy (pMN), potentially positioning the anti-CD20 antibody as the first FDA-approved therapy for the rare autoimmune kidney disease. The agency is expected to complete its review
EIRs/483s
GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, paving the way for regulatory submissions that could establish the drug as the first immunotherapy to
EIRs/483s
FDA has granted Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with hormone receptor (HR)-positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy. The 6/24 approval expands the use of the
EIRs/483s
FDA has appointed Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs. In this capacity, she will head the agency’s Office of Policy, Legislation, and International Affairs, which serves as the focal point for engaging with Congress, the administration, global counterparts and partners, and
EIRs/483s
An FDA review of records submitted by Linghai ZhanWang Biotechnology Co. in Jinzhou, Liaoning, China, in response to an agency 2/26/2024 request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drugs. A 2/25
EIRs/483s
Johnson & Johnson is discontinuing the Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to a lack of sufficient efficacy data in the target patient population. “The data confirmed aticaprant is safe and well-tolerated, and no new safety signals were identified,
EIRs/483s
Elon Musk’s Department of Government Efficiency (DOGE) is claiming that it terminated the leases of 30 FDA field offices and laboratories throughout the U.S. The largest is a laboratory facility in St. Louis, MO, a 51,963 sq. ft. field office and laboratory that costs about $2.5
EIRs/483s
PharmaTher Holdings says it has resubmitted its NDA for Ketarx (ketamine) to address “minor” deficiencies cited in a 10/22/2024 complete response letter (see earlier story). The submission is seeking the drug’s use in anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The company says it
EIRs/483s
FDA has approved an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine. The company says RizaFilm is a proprietary orally disintergrating thin-film formulation of rizatriptan benzoate, the active ingredient in Merck’s Maxalt. IntelGenx says FDA completed a “successful pre-approval inspection” earlier
EIRs/483s
Two recent medical product cases could be a harbinger of more Department of Justice (DoJ) deferred prosecution agreements (DPAs) as a vehicle to resolve False Claims Act (FCA) suits, according to lawyers from Troutman Pepper. Earlier this year, Pennsylvania-based Jet Medical agreed to a $745,000 DPA to resolve
EIRs/483s
FDA commissioner Robert Califf continues to call for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e.g., ChatGPT and other competitors) it is just a matter of time before the agency receives its first “AI-assisted” marketing submission. “As we develop much better
EIRs/483s
Don’t hold your breath thinking FDA will soon eliminate preclinical animal testing and allow other data forms like in vitro or in silico or some other kind of modeling data to support pre-clinical data requirements after the recent Food and Drug Omnibus Reform Act (FDORA) gave the agency
EIRs/483s
Federal Register notice: FDA is classifying prognostic tests for assessing liver-related disease progression into Class 2 (special controls). The devices are intended to measure one or more analytes obtained from human samples as an aid in assessing liver disease progression. The agency notes that they are not intended for
EIRs/483s
FDA has approved a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. Patients with ESRD rely on AV fistulae for hemodialysis, and over time vessel restenosis limits
EIRs/483s
FDA has extended by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes who have established cardiovascular disease or are at risk for the disease. The submission also applies
EIRs/483s
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory, Changzhou City, China (5/11):FDA inspected the firm in February and documented significant GMP deviations associated with its active pharmaceutical ingredients.