Drugs
A 10/10-10/14/22 FDA inspection at the Zermat International drug manufacturing facility in Tlalnepantla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/6 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has published a draft guidance, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment, with information and recommendations to assist sponsors and other interested parties in developing drugs to prevent or treat acute radiation syndrome caused by exposure to ionizing radiation from accidental or deliberate events. The document is
Drugs
The National Cancer Institute (NCI) says Syndax Pharmaceuticals’ revumenib, a menin inhibitor, showed promise in an early-stage clinical trial for treating acute myeloid leukemia. An NCI statement says treatment with revumenib in the AUGMENT-101 trial caused about one-third of study participants’ cancers to completely disappear. The statement
Drugs
An FDA online statement says drug compounders should know their active pharmaceutical ingredient (API) and excipient suppliers and know if the suppliers are testing the components for purity and quality before they are purchased for use in compounding. The statement says that improper repackaging or lack of supply chain transparency
Drugs
A ProPublica report says FDA has been very slow to ramp up domestic and foreign drug manufacturer inspections following the Covid-19 pandemic. “Three years after the pandemic started, FDA has been slow to return to pre-pandemic inspection rates,” the analysis says. “The pandemic heightened the urgency surrounding FDA’
Drugs
Sidley attorneys say a 4/12 FDA final guidance, A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers, “reinforces the significant expectations for oversight by trial sponsors, the need for them to have a comprehensive quality risk management approach, and the particularly acute obligations for companies that
Drugs
GenBioPro, the generic drug maker of abortion drug mifepristone, filed a 4/19 lawsuit against FDA in Maryland federal court to block the agency from taking any actions against the company if a pending court order under review by the U.S. Supreme Court requires the drug to be restricted
Drugs
FDA has approved a new indication for AbbVie’s Qulipta (atogepant) to include the preventive treatment of migraine in adults. A company statement says Qulipta is the only oral calcitonin gene-related peptide receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication was based on the Phase
Drugs
An ongoing European Medicines Agency (EMA) and FDA joint initiative on information sharing involving generic drug bioequivalence study inspections has just grown by one more EU Member state — Ireland. The countries now participating in the FDA/EMA information sharing pact are: Austria, France, Germany, Ireland, Italy, The Netherlands, Spain, and
Drugs
Two CDER Office of Orphan Products Development researchers say lessons learned from rare disease product development during the Covid-19 pandemic can be applied to future trials in rare diseases. Writing in Contemporary Clinical Trials, the authors say the two important lessons were: * virtual capabilities, when appropriate, can be an
Drugs
The CDER Office of New Drugs (OND) Regulatory Research Program, which was started in 2018 to centralize and create an infrastructure for OND regulatory science research, recently published its first two fiscal year annual reports. Research Program associate director Laura Jaeger says in an online post the reports “are a
Drugs
FDA has issued Azure Biotech an emergency use authorization (EUA) for the Azure Fastep Covid-19 Antigen Pen Home Test, an over-the-counter product that displays results in 15 minutes. “The test can be used for serial testing for people who have symptoms within the first six days of
Drugs
Having accepted a proposal from FDA chief scientist Namandjé Bumpus for an advisory committee to review and address a 2021 CDER refusal to approve a company NDA for ITCA 650 (exenatide in DUROS device), Itarcia is expressing concerns about the committee’s composition and functioning. Minutes of a 4/3
Drugs
Researchers from FDA and RTI International say data displays in prescription drug advertising geared to healthcare providers are often “highly complex.” Writing in Therapeutic Innovation & Regulatory Science, the researchers say information conveyed in prescription drug promotion data displays vary in their presentation and complexity. The study characterized the content
Drugs
An FDA 10/31-11/8/22 inspection at the Royal Chemical Company drug manufacturing facility in East Stroudsburg, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/5 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Drugs
A joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee 4/14 voted 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient data to allow identification of a population in whom the benefits
Drugs
Avenue Therapeutics says it has had a Type C meeting with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous (IV) tramadol for treating post-operative pain. “The purpose of this meeting was to discuss and reach agreement with the FDA on the proposed study
Drugs
GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The submission will be based on “positive results” from the pivotal EAGLE-2 and EAGLE-3 Phase 3 trials that were stopped
Drugs
FDA has approved a Gamida Cell Ltd. BLA for Omisirge (omidubicel-onlv), a modified allogeneic (donor) cord blood-based cell therapy to speed recovery of neutrophils in the body and reduce infection risks. The therapy is intended for use in adults and pediatric patients 12 years and older with blood
Drugs
FDA has issued Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis (UC). In the letter, the agency cited issues related to the proposed manufacturing of mirikizumab, “with no concerns about the clinical data package, safety, or label for the medicine,
Drugs
The U.S. Supreme Court has ordered an administrative stay until 4/20 of a lower court’s 4/7 order (see earlier story) that would restrict the distribution of the abortion drug mifepristone. The stay gives the high court additional time to review a 4/14-filed appeal by
Drugs
A 4/13 letter from five House Republicans is questioning FDA commissioner Robert Califf on agency safeguards in place when questionable foreign-made generic drugs are allowed to enter the country to prevent drug shortages. At issue is FDA’s decision to allow Glenmark Pharmaceuticals to import atovaquone from a