Drugs
FDA has posted a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China, documenting significant GMP deficiencies with the firm’s active pharmaceutical ingredient manufacturing. For example, the form took exception to Sichuan’s laboratory records not being completed contemporaneously
Drugs
Social and behavioral scientists working in the CDER Office of Communications are testing some Center drug-related messages and information to ensure they are clear and understandable to their target audiences. Alexandria Smith, a social scientist on the Research and Risk Communications staff, says in an online post that the
Drugs
FDA has accepted a Bristol Myers Squibb sNDA for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. The agency set a PDUFA action date on the sNDA of 10/8, a Bristol
Drugs
Amneal Pharmaceuticals has resubmitted an NDA for IPX203, a novel oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for treating Parkinson’s disease. The filing addresses issues raised in a 7/2023 complete response letter related to safety concerns, according to the company. “The resubmission package included data
Drugs
FDA and the European Medicines Agency (EMA) are expanding their Parallel Scientific Advice (PSA) pilot program to include a voluntary pilot on complex generic or hybrid drugs. (Hybrid drugs is an EMA term that loosely corresponds to FDA’s complex generics terminology.) Writing in an online post, CDER Office of
Drugs
Gilead Sciences is discontinuing its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed all magrolimab studies in myelodysplastic syndromes and AML, including related expanded access programs, on full clinical hold. The company’s and FDA’s decisions follow an independent data monitoring committee’
Drugs
A bipartisan group of House members is introducing legislation dubbed FDA Modernization Act 3.0 to require the agency to implement animal testing reforms that Congress approved over a year ago. In a statement, Animal Wellness Action, the Center for a Humane Economy, and Animal Wellness Foundation said the 2022
Drugs
FDA has published a draft guidance, Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act, to assist manufacturers and applicants in providing FDA timely, informative notifications about changes in the production of certain finished
Drugs
An 8/14-8/18/2023 FDA inspection at the Les Importations Herbasanté drug manufacturing facility in Saint-Laurent, Canada, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/31 Warning Letter says the specific violations were: * failing to appropriately sample, test, or examine
Drugs
FDA says its review of records requested from Nantong Furuida Packaging Products Co., Ltd., in Jiangsu Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drugs. A just-released 11/17/2023 Warning Letter says
Drugs
FDA has told Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time,” according to the company. The submission seeks the drug’s use for treating insomnia characterized by difficulties with sleep initiation.
Drugs
The Duke-Margolis Institute for Health Policy says there are three steps Congress could take to reduce chronic drug shortages. In a 2/5 letter to the House Ways and Means Committee, the institute says many drug shortages are caused by manufacturing quality issues. “Ultimately,” it says, “this poor performance
Drugs
FDA declined an invitation to testify about its foreign inspection program at a 2/6 House Energy and Commerce Oversight and Investigations Subcommittee hearing and received heat from chairman Morgan Griffith (R-VA) over their absence. Other inspection-related hearings will be planned in the future and if FDA rejects
Drugs
A Bloomington, IN, Catalent facility that is being used by Novo Nordisk to expand production of its popular weight-loss drug Wegovy (semaglutide) is not meeting FDA safety and quality requirements. Bloomberg News reports that it obtained an FDA report on its 10/2023 and 11/2023 inspection at the
Drugs
FDA has approved a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator (SARM) and its use in preserving muscle mass and physical function and increasing fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist (GLP-1
Drugs
Insight Pharmaceuticals is recalling two lots of its TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid due to elevated benzene levels. The company says that a recent review by a third-party lab found that samples from two lots of the product contained the elevated benzene levels. “While
Drugs
Arizona-based Centera Bioscience (doing business as: Nootropics Depot) and CEO Paul Eftang were sentenced 2/5 in federal court in Concord,NH for distributing unapproved drugs, including tianeptine, into interstate commerce. Centera Bioscience was sentenced to three years of probation, and Eftang to one year of probation. “The defendants
Drugs
Johnson & Johnson is reporting positive data from two studies involving its monoclonal antibody nipocalimab. In the pivotal Phase 3 VIVACITY study, it says nipocalimab met the primary endpoint and achieved a statistically significant reduction in a generalized myasthenia gravis score from baseline over weeks 22 to 24 compared with
Drugs
FDA has released a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.” The document is intended to assist registrants of drug establishments in submitting reports to the agency on the amount of each listed drug manufactured,
Drugs
Ainos has responded to an FDA clinical hold on its low-dose oral interferon (IFN)-alpha formulation, Verona, by seeking to begin a Phase 2 trial of the drug for mild Covid-19 symptoms. If given the green light, the company says the Phase 2 multicenter, parallel, randomized study will
Drugs
Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis (CF) combination drug, once-daily vanzacaftor/tezacaftor/deutivacaftor (vanza triple). The decision to submit the NDA comes as the company is reporting Phase 3 data that show the treatment met
Drugs
Congressman Mike Waltz (R-FL) has written FDA Commissioner Robert Califf asking for clarification on the agency’s “telework policies… which have minimized the operational standards for approving critical drugs and therapeutics.” Waltz noted in his 2/1 letter that it has been four years since the beginning of the