Drugs
FDA has issued a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns therapeutic equivalence codes in the agency’s Approved Drug Products With Therapeutic Equivalence Evaluations (aka, the Orange Book). The document, “Evaluation of Therapeutic Equivalence,” describes the scientific and regulatory principles the agency
Drugs
A 1/13-1/30 FDA inspection at the Safrel Pharmaceuticals drug manufacturing facility in Dayton, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/7 Warning Letter says Safrel failed to establish an adequate quality unit and to have in writing and
Drugs
FDA has granted Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and older with glycogen storage disease type Ia (GSDIa). The action marks the first gene therapy approval for Ultragenyx and the company’s fifth FDA approval overall. Ultragenyx also received an
Drugs
FDA has issued a complete response letter to Xspray Pharma for its NDA for Dasynoc (dasatinib), the company’s product candidate to treat chronic myeloid leukemia and acute lymphoblastic leukemia. A company statement says the FDA letter relates to the agency’s previously communicated observations about CGMP issues at NerPharMa,
Drugs
A 3/2-3/5 FDA inspection at the Suretec Innovations drug manufacturing facility in Gilbert, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 Warning Letter says the four specific violations were: * failure to test samples of each component for identity
Drugs
FDA has accepted for review a Teva Pharmaceuticals NDA for ecopipam, a company-described first-in-class investigational therapy for treating pediatric patients with Tourette syndrome. If approved, the drug would become the first new treatment option indicated for pediatric patients with Tourette’s in more than 10 years and
Drugs
A 2/4-2/6 FDA inspection at the Auriga Research contract testing laboratory in Bengaluru, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 Warning Letter says the specific violations were: * failure to ensure that laboratory records included complete data derived
Drugs
Merck and Moderna say the Phase 3 INTerpath-001 trial of Keytruda (pembrolizumab) plus intismeran autogene (intismeran; V940 or mRNA-4157) met the endpoints of recurrence-free survival and distant metastasis-free survival in patients with completely resected stage IIB-IV melanoma. A Merck statement says the results are the
Drugs
An FDA 1/20-2/13 inspection at the K.C. Pharmaceuticals drug manufacturing facility in Pomona, CA, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 Warning Letter says the specific violations were: * failure to establish and follow appropriate written procedures
Drugs
FDA has approved Regneron’s Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), a rare genetic disease caused by a mutation in activin A receptor-type 1, which controls new bone
Drugs
A 2/16-2/27 FDA inspection at the Eugia Pharma drug manufacturing facility in Kolthur Village, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 Warning Letter says the specific violations were: * failure to perform operations within specifically defined areas of
Drugs
FDA has cited Neeyaan LLC for multiple GMP deficiencies, including the firm’s failure to validate drug manufacturing processes, conduct cleaning validation and adequately test incoming raw materials. In a just-posted untitled letter, FDA said the company failed to establish and follow adequate written procedures for production and process
Drugs
FDA’s review of records it requested from Tianjin Kilo Pharmaceutical Sci-tech Co. in Tianjin Shi, China, found four significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). An 8/6 Warning Letter says the specific deviations were: * failure to demonstrate that the company’
Drugs
McGuireWoods partner Clint Narver is leaving the law practice to rejoin FDA as director of the Office of Compounding Quality and Compliance (OCQC). His final day at the firm will be 8/21. OCQC develops and implements federal drug compounding policy, oversees pharmacy compounders and outsourcing facilities nationwide, and runs
Drugs
Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide after new data show significantly reduced hypoglycemic events in a Phase 3 clinical trial involving patients with post-bariatric hypoglycemia (PBH).The company just reported topline results from the 78-participant
Drugs
Valisure has sued the United States Pharmacopeia (USP), accusing the standards-setting organization of making false and misleading statements about the laboratory's methods for detecting potentially harmful impurities in medicines. The lawsuit centers on a 2023 USP white paper titled Unvalidated Methods for Medicine Quality Testing Can Lead
Drugs
FDA has issued a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or through the 505(b)(2) NDA pathway. The document, Determining Whether to Submit
Drugs
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended the revocation of the drug’s marketing authorization, according to a document outlining concerns. Last month, Amgen submitted to FDA new scientific data and analyses as part of its formal
Drugs
Regeneron Pharmaceuticals has stopped a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveitis after a safety event prompted the company to reassess the drug's risk-benefit profile, according to a clinicaltrials.gov posting. Regeneron said the decision to terminate
Drugs
FDA is announcing a 9/9 meeting with the Reagan-Udall Foundation for the FDA to hear public comments on perspectives involving opioid medication use for managing pain and addiction. The meeting will also feature a panel discussion with federal partners to discuss efforts to improve the pain management and
Drugs
FDA has approved Lantheus Holdings’ Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease. The approval covers use of the imaging agent, also known as MK-6240, for brain positron emission tomography
Drugs
FDA has granted OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. OS Therapies says an interim three-year overall