Drugs
FDA has release a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). The document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of the sponsor’s NDA
Drugs
FDA has lifted a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold was the result of the company’s recent report to the agency about a Grade 5 serious adverse event
Drugs
FDA is considering changes to its accelerated approval program, such as international harmonization efforts to “strengthen this approval pathway by considering the differences between expedited programs, including recent innovation by international [regulatory health agencies] RHAs,” according to Oncology Center of Excellence director Richard Pazdur and two other CDER officials. Writing
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FDA has granted Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma (r/r MM). AO-176 is in Phase 1/2 clinical trials for treating patients with r/r MM, as well as select solid tumors as monotherapy and in
Drugs
FDA has issued Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency (GHD) in pediatric patients. Pfizer says it is evaluating the agency’s comments to determine an appropriate path forward.
Drugs
FDA has launched its Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard, an interactive Web-based tool to analyze REMS data in a user-friendly way. An agency announcement says the tool is intended to “expand efficient access to data and report-generating capabilities of REMS programs for healthcare providers,
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FDA commissioner nominee Robert Califf says he’s a “fan” of the accelerated approval process but wants to see changes to speed confirmatory trials to determine if therapies that are given accelerated approval deliver the benefit they claim. Speaking as a member of a panel on accelerated approval at the
Drugs
FDA has placed a clinical hold on Dyne Therapeutics’ IND for a clinical trial of its DYNE-251 in patients with Duchenne muscular dystrophy amenable to skipping exon 51. The agency requested additional clinical and non-clinical information for Dyne-251, the company says. Dyne says it expects to submit
Drugs
Aurobindo Pharma has been issued an FDA Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient (API) manufacturing facility. This is the second Warning Letter issued to the company in the past 15 months. Its U.S subsidiary, AuroLife Pharma, was
Drugs
Mylan Pharmaceuticals has recalled one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to the potential for the label to be missing on some prefilled pens within a labeled carton (each containing five pens). The affected batch was manufactured by
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The latest annual user fee program data show the agency met or exceeded many of its goals under PDUFA and BsUFA. The report says the agency met or exceeded the performance level for 10 out of 12 review goals for FY 2020 final performance. And, it says, FDA is currently
Drugs
After 20 years at FDA, CDER Office of Neuroscience deputy director Eric Bastings has retired and joined Ionis Pharmaceuticals as vice president of development strategy. Bastings’s retirement comes at a difficult time for the Office of Neuroscience, which oversaw last year’s controversial approval of Biogen’s Alzheimer’s
Drugs
FDA has told Revance Therapeutics that to address a recent BLA complete response letter on DaxibotulinumtoxinA for Injection, indicated for treating glabellar lines, will require qualification of a new working cell bank (WCB). The qualification, which the company says is in progress, will need to be verified by a reinspection
Drugs
FDA has agreed to Akari Therapeutics using a next-generation manufacturing process to produce nomacopan for use in two Phase 3 trials. The company says the new process increases the final yield of nomacopan by at least five-fold, significantly lowering the cost of goods for clinical studies and commercialization.
Drugs
FDA has placed a partial clinical hold on multi-dose clinical trials of Yumanity Therapeutics’ YTX-7739 that is being developed to treat Parkinson’s disease. The company says the agency has not halted all clinical programming and is permitting Yumanity to proceed with its planned single-dose clinical trial.
Drugs
Gilead says an unauthorized network of drug distributors and suppliers sold pharmacies more than $250 million in counterfeit versions of two of its HIV drugs over the last two years. The company said it had determined that 85,247 bottles of drugs including its Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
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A 5/7-6/23/21 FDA inspection at the Professional Disposables drug manufacturing facility in Orangeburg, NY, found significant violations of Current Good Manufacturing Practice (CGMP) regulations and Field Alert Reporting regulations. A 1/7 Warning Letter says the company failed to thoroughly investigate any unexplained discrepancy or failure
Drugs
A 1/12-2/18/21 FDA inspection at Sunstar Americas’ drug and medical device manufacturing facility in Schaumburg, IL, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and Quality System regulations for medical devices. A just-released 12/21/21 Warning Letter says specific
Drugs
FDA has published case study examples to educate stakeholders and provide innovation in the area of complex innovative trial designs (CID). An agency notice says the CID pilot meeting program, launched in 2018, is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. “The
Drugs
FDA has released the FDA-483 issued following a 10/18-10/26/21 inspection at the Catalent Belgium fill and finish drug manufacturing facility in Brussels, Belgium. The seven inspection observations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components
Drugs
An FDA review of records supplied by Cosmo Bio Co., a Yuseong-gu Daejeon, South Korea, manufacturer of over-the-counter drug products, identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. A 1/6 Warning Letter says specific violations were: * failing to have, for each
Drugs
FDA has issued Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and distress associated with Prader-Willi syndrome (PWS). CDER’s Division of Psychiatry concluded that, while LV-101 appears to be generally safe and well tolerated, the