Drugs
FDA’s vast responsibilities — regulating and monitoring everything from drug and device safety to the food supply and cosmetics — make it one of the most important federal agencies. Yet former Alliance for a Stronger FDA executive director and now regulatory expert and author of the blog FDA Matters (www.fdamatters.
Drugs
A 3/3-3/7 FDA inspection at the Wisconsin Pharmacal drug manufacturing facility in Jackson, WI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/22 Warning Letter says the specific violations were: * failure of the quality control unit to exercise its responsibility
Drugs
Johnson & Johnson has halted development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis (RA) after a mid-stage proof-of-concept study failed to show added benefit. The Phase 2a DAISY trial tested nipocalimab, an anti-FcRn antibody, alongside a tumor necrosis
Drugs
Novocure has terminated its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields (TTFields) together with Merck’s Keytruda (pembrolizumab) in metastatic non-small cell lung cancer (NSCLC) patients previously treated with a PD-1/PD-L1 inhibitor and platinum chemotherapy. The company notified trial sites
Drugs
FDA has approved a Foresee Pharmaceuticals NDA for Camcevi ETM (leuprolide mesylate), a once every three months injectable formulation for treating advanced prostate cancer. The drug was previously approved for six-month dosing. The approval was based on data from a Phase 3 study involving 144 patients with advanced prostate
Drugs
An FDA review of a Web site maintained by Platinum Biologics of Orlando, FL, determined that the company sells two umbilical cord-derived products and two exosome products, all for allogenic use. An 8/15 Warning Letter says the four products are unapproved new drugs and unlicensed biological products. The
Drugs
FDA has issued Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix (89Zr-DFO-girentuximab), an investigational positron emission tomography (PET) imaging agent designed to help diagnose and characterize clear cell renal cell carcinoma. The letter cited deficiencies in the drug’s chemistry, manufacturing, and controls
Drugs
FDA has rejected Outlook Therapeutics’ resubmitted BLA for Lytenava (bevacizumab-vikg), a proposed treatment for wet age-related macular degeneration (wet AMD), citing insufficient evidence of effectiveness. In a complete response letter issued this week, the agency said it could not approve the application in its current form because the
Drugs
AdventaPharma is asking FDA not to approve any ANDA using Novo Nordisk’s Ozempic (semaglutide injection) as the reference-listed drug unless two conditions are met. The 8/26 petition says FDA should require that: * the generic drug/device combination product includes a pen injector that is functionally equivalent to
Drugs
FDA has accepted a Bayer NDA for gadoquatrane, a next-generation gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). The submission seeks approval for contrast-enhanced MRI of the central nervous system and other body regions in adults and children, including newborns. If approved, gadoquatrane would
Drugs
FDA is recommending an additional, earlier MRI monitoring scan before the third infusion of Eisai/Biogen’s Leqembi (lecanemab) for Alzheimer’s disease patients. An agency statement says the earlier monitoring “can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or
Drugs
FDA has released the form FDA-483 issued following a 7/15-7/25 inspection at IntegraDose Compounding Services, a Minneapolis, MN, outsourcing facility. The form’s six inspection observations were: * failure to write and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure
Drugs
Amylyx Pharmaceuticals says it will discontinue development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in progressive supranuclear palsy (PSP) after the drug failed to show benefit in a mid-stage clinical trial. The Phase 2b ORION study found no differences between AMX0035 and placebo on primary or secondary
Drugs
BioXcel Therapeutics says its pivotal Phase 3 SERENITY At-Home trial met its main safety endpoint, supporting a planned supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL501) for unsupervised use in patients with bipolar disorders or schizophrenia. The 12-week, placebo-controlled study evaluated BioXcel’
Drugs
FDA has released the form FDA-483 issued following a 7/28-8/9 inspection at Hikma Injectables USA, Inc., a Dayton, NJ, outsourcing facility. The four inspection observations were: * failure to establish written procedures for production and process controls designed to assure that the drug products have the identity,
Drugs
In a letter to FDA organized by the UCLA Law Center on Reproductive Health, Law, and Policy and Advancing New Standards in Reproductive Health at the University of California, San Francisco, more than 260 reproductive health researchers nationwide affirm the 25-year safety record of the medication abortion drug mifepristone
Drugs
FDA says the CDER Office of New Drugs has accepted an Echosens Letter of Intent to qualify Liver Stiffness Measurement by Vibation-Controlled Transient Elastography as a reasonably likely surrogate endpoint for clinical trials in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis.
Drugs
FDA has accepted for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage (ASH). The company says the submission was supported by a comprehensive data package including positive data obtained from the company’s Phase 3 STRIVE-ON safety trial of
Drugs
Regeneron Pharmaceuticals says it will seek FDA approval early next year for its investigational RNA-based therapy cemdisiran after announcing results from the Phase 3 NIMBLE trial where all primary and key secondary endpoints were met for treating generalized myasthenia gravis. Cemdisiran is described by the company as an siRNA
Drugs
Eli Lilly says it will soon seek FDA approval for its investigational obesity pill orforglipron following its 8/26 release of “positive topline results” from the Phase 3 ATTAIN-2 trial that evaluated the oral GLP-1 receptor agonist in obese or overweight adults with Type 2 diabetes. “In the
Drugs
FDA has granted fast-track designation to Allarity Therapeutics’ stenoparib, an investigational treatment for patients with advanced ovarian cancer. A company statement describes stenoparib as an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. The company says it recently began patient enrollment under a
Drugs
The Biotechnology Innovation Organization (BIO) says its priorities for when Congress returns in September are reauthorization of the FDA Pediatric Priority Review Voucher (PPRV) program and the Small Business Innovation Research/ Small Business Technology Transfer (SBIR/STTR) seed-funding program. An online statement says patients and innovators have been relying