Drugs
Amneal Pharmaceutical is recalling two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the products may contain an inert fiber identified as polypropylene fibers from the IV bag. The product being recalled is indicated for producing local or regional anesthesia for surgery or acute pain
Drugs
FDA is alerting health care providers about reports of falsely elevated (false positive) results that have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with LeadCare Testing Systems. “These tests may overestimate blood lead levels and give inaccurate results when processing capillary
Drugs
An 8/1-8/28/2024 FDA inspection at the Empower Pharma drug outsourcing facility in Houston, TX, found that drugs the facility compounds failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) necessary for the facility to qualify for exemptions from
Drugs
The DC federal court has rejected Norwich Pharmaceuticals’ request for summary judgment in a case seeking FDA final approval of its ANDA for rifaximin tablets. Instead, the court granted summary judgment to FDA and also to Teva and Salix, who intervened in the proceedings as defendants. Salix owns the branded
Drugs
Speaking at the Semafor World Economy Summit, FDA commissioner Martin Makary said the agency has “no plans to take action” to restrict the availability of mifepristone, the pill used in most U.S. medication abortions. He hedged his statement a bit, saying that an ongoing set of data on the
Drugs
The Association for Clinical Oncology (ASCO) has written to the new heads of FDA, the National Institutes of Health, and the Centers for Medicare and Medicaid Services to ensure continued progress in cancer care, research, and patient access. An ASCO statement says that in its letter to FDA commissioner Martin
Drugs
Bristol Myers Squibb says its Cobenfy (xanomeline and trospium chloride) used as an adjunctive treatment to atypical antipsychotics in the Phase 3 ARISE trial “showed a numerical improvement compared to treatment with a placebo and an atypical antipsychotic.” A company statement says the Cobenfy adjunctive treatment was associated with improvement
Drugs
Former FDA associate commissioner Peter Pitts says the agency doesn’t routinely update drug labels with safety information for people with obesity. “The agency…doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large-scale clinical trials
Drugs
Eli Lilly says it has sued four more drug compounders for selling unapproved products containing tirzepatide, the active ingredient in its weight loss and diabetes medicines, including Mounjaro. A company statement says compounders had been permitted to produce copies of obesity drugs when FDA listed them as being in shortage.
Drugs
Vanda Pharmaceuticals says FDA is using recent staff cuts and a new commissioner as its “new scapegoat” to delay Vanda’s request for a hearing on the NDA approvability of tradipitant for gastroparesis. Earlier this year, FDA gave the company an opportunity for a hearing to contest an agency complete
Drugs
Akeso says its first-in-class PD-1/VEGF bispecific antibody ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer. The HARMONi-6 (AK112-306) trial showed that ivonescimab combined with chemotherapy significantly outperformed a
Drugs
The International Council for Harmonization endorsed on 4/11 and released for public consultation the Q1 guidance Stability Testing of Drug Substances and Drug Products. The document outlines the stability data expectations for drug substances and drug products and applies to marketed drug products, including those associated with registration and
Drugs
FDA says it is aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. An agency alert says FDA has approved two oral finasteride products for different indications — Organon’s Proscar and Propecia. “Currently, there is no FDA-approved topical formulation of finasteride,” it
Drugs
AstraZeneca and Daiichi Sankyo are announcing interim data from the Phase 3 DESTINY-Breast09 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pertuzumab, significantly extended progression-free survival (PFS) compared to the current first-line standard of care (taxane, trastuzumab, and pertuzumab (THP)) in HER2-positive metastatic breast
Drugs
The recent FDA layoffs are raising red flags across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approvals and challenge companies’ ability to maintain compliance with federal regulations. HHS laid off about 3,500 full-time FDA employees earlier this month, impacting key
Drugs
Researchers have published two articles on rare disease drug development in the Journal of Biopharmaceutical Statistics. The first discusses the role of regulatory flexibility in the review and approval process of rare disease drug development. It notes that this issue was recently studied by a National Academy of Sciences, Engineering,
Drugs
Exiger, a business consulting firm, says the U.S. drug supply chain “faces critical risks stemming from deep dependence on foreign drug manufacturers, complex geopolitical dynamics, and unethical international sourcing practices.” In a new white paper, “A Bitter Pill: America’s Dangerous Dependence on China-Made Pharmaceuticals,” Exiger cites these
Drugs
Under a 4/15 presidential Executive Order, FDA has 180 days to issue a report with recommendations to (1) accelerate the approval of generics, biosimilars, combination products, and second-in-class branded medications; and (2) improve the process through which prescription drugs can be reclassified as over-the-counter medications.
Drugs
A new citizen petition is asking FDA to amend the requirements under 21 CFR Part 211 (current good manufacturing practice for finished pharmaceuticals) to mandate the use of separate sampling logbooks or equivalent electronic logs for all sampling activities, including raw materials, in-process materials, finished products, and stability samples.
Drugs
The 9/18-9/19/2024 Global Summit on Regulatory Science was hosted by FDA with the theme “Is Regulatory Science Ready for Artificial Intelligence?” A report from the conference, published in the open-source NPJ Digital Medicine, includes 10 key principles for regulating artificial intelligence (AI) described by former
Drugs
FDA says its review of a Web site maintained by the Naturista Store in Downey, CA, determined that the company is illegally marketing the Advance King product for sale in the U.S. A just-released 3/26 Warning Letter says Advance King is an unapproved new drug that is
Drugs
An 11/4-11/8/2024 FDA inspection at the PMS4PMS drug manufacturing facility in Clarence, NY, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/7 Warning Letter says the specific CGMP violations were: * failure to have, for each batch of drug product,