Drugs
FDA is announcing a new opportunity for drug companies to participate in a pilot program designed to expedite the review of new therapies addressing unmet medical needs. Starting 12/2 , CDER and CBER will each accept one to two original marketing applications as part of the STAR pilot program. The
Drugs
FDA has agreed on a Phase 3 study (APOLLO) design for Disc Medicine’s bitopertin and its use in treating erythropoietic protoporphyria (EPP), a rare and debilitating condition. The study design was recently discussed during an end-of-Phase 2 meeting that provided a “clear path forward for bitopertin,” the
Drugs
FDA has cleared a Quanta Dialysis Technologies 510(k) for the use of its Quanta Dialysis System in the home setting. The device is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in the home by trained patients in tandem with a
Drugs
A September inspection of Mark Cuban’s Cost-Plus Manufacturing and Compounding facility in Dallas, TX, resulted in a seven-item Form FDA-483 that cited significant GMP issues. For example, the inspection found that procedures designed to prevent microbiological contamination are not established. It also found that the firm’
Drugs
FDA has accepted for review an Ionis Pharmaceuticals NDA for donidalorsen, an RNA-targeted treatment for preventing hereditary angioedema (HAE) attacks in patients aged 12 years and older. The agency has set a user fee review action target date of 8/21/2025. The submission is based on data from
Drugs
FDA has approved a Phaxiam Therapeutics IND for a Phase 2 study (GLORIA) to evaluate its anti-Staphylococcus aureus (S. aureus) phages in prosthetic joint infections (PJI) caused by the bacteria. The study plans to include 100 patients with PJI (hip or knee replacement) with open surgical debridement who will
Drugs
FDA has approved a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. Approval is based on data from two Phase 3 clinical trials that met all co-primary and secondary endpoints, and subjects completed the 16-week treatment
Drugs
FDA has approved a modification to the opioid analgesic risk evaluation and mitigation strategy (OA REMS) to require manufacturers of such products that are dispensed in outpatient settings to provide pre-paid drug mail-back envelopes (MBEs) upon request to pharmacies and other opioid dispensers. “The manufacturers have developed a
Drugs
FDA has selected former Leavitt Partners consultant Amy Comstock Rick to serve as strategic coalitions director for the newly created Rare Disease Innovation Hub. In this role, Rick will report directly to the hub’s co-leaders — CDER director Patrizia Cavazzoni and CBER director Peter Marks — and she will act
Drugs
A 9/12-20 FDA inspection of Aarti Drugs Ltd’s active pharmaceutical ingredient (API) manufacturing plant in Maharashtra, India has been issued a seven-item FDA Form-483 over significant GMP violations. For example, the agency cited the firm because its written procedures are not established and followed for
Drugs
Senator Marco Rubio (R-FL) is asking for immediate FDA action against two pharmaceutical companies based in China’s Xinjiang region that reportedly supply products to the U.S. despite concerns over forced labor. In a 10/30 letter to FDA commissioner Robert Califf that was sent amid heightened scrutiny
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee 10/31 voted 11 to 3 against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) as an adjunctive treatment to insulin for adults with Type 1 diabetes and chronic kidney disease. The committee's primary concern centered on safety, specifically
Drugs
The DC federal court says FDA acted correctly in determining that Avadel CNS Pharmaceuticals’ Lumryz (sodium oxybate) is a different drug than Jazz Pharmaceuticals’ Xywav (sodium oxybate) because of a different dosing regimen, and thus correctly approved the Avadel product for marketing before Xywav finished its orphan drug marketing exclusivity.
Drugs
FDA is reminding drug compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile. “The agency is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make intravenous products,” an agency statement says. “Ingredients identified as food-
Drugs
FDA says that following a review of stability data submitted by Baxter International, whose North Carolina manufacturing plant was closed by Hurricane Helene, the agency has extended use dates for some specified parenteral products. “Providers and patients that have the lot numbers in stock will be able to use them
Drugs
FDA says Chemigroup France (formerly known as Cheminova Laboratories) is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids. The products, which are found at skincap.com, amazon.com, and walmart.com, are marketed for treating psoriasis, seborrheic dermatitis and typical eczema, painful lichen, skin redness, dandruff, itching
Drugs
FDA has cleared an Exactech 510(k) for the Truliant Porous Tibial Tray, a 3D-printed tibial knee implant that is designed to mimic the structure of cancellous bone. “This design aims to facilitate both initial and biological fixation, designed to accommodate patients' active lifestyles,” the company says. It
Drugs
FDA has cleared an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine for managing painful skin wounds. The company says the device uses its patented synthetic matrix to deliver ionic and metallic silver along with lidocaine, “providing both antimicrobial protection and local
Biologics
Responding to an FDA request for comments on total lifecycle considerations for generative artificial intelligence-enabled medical devices, AstraZeneca says it is important that the agency use a risk-based approach to the regulation of artificial intelligence/machine learning (AI/ML). “Risk-based frameworks are an important regulatory tool used
Drugs
UCB says its investigational Alzheimer’s drug bepranemab failed to meet its primary endpoint in the full population in the Phase 2a TOGETHER study, but slowed cognitive decline and the rate of tau accumulation in key secondary endpoints. The company says the study is investigating the safety, efficacy, and tolerability
Drugs
Verastem Oncology has completed a rolling NDA for the potential first-in-class combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral selective FAK inhibitor, for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy. The company
Drugs
FDA has published the International Council for Harmonization’s M13A guidance, Bioequivalence for Immediate-Release Solid Oral Dosage Forms, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation. The document