Drugs
FDA says that all 53 new molecular entity approvals (see earlier story) in 2020 were acted on by or before their user fee goal dates, and most were approved in the U.S. before any other country in the world. In a 1/8 annual approvals report, the agency says
Drugs
FDA has placed a clinical hold on a Neoleukin Therapeutics Phase1 clinical trial of its immunotherapeutic candidate, NL-201. The agency told the company that it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and
Drugs
CDER has announced that a planned Office of Generic Drugs (OGD) reorganization has been approved and will be implemented later this year. The new structure is intended to strengthen OGD’s operations and allow it to meet generic drug review expectations, according to an agency release. Changes include establishing a
Drugs
FDA is continuing its review of a Bristol-Myers Squibb (BMS) BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, following the completion of an inspection at third-party manufacturer Lonza. In November, the agency
Drugs
FDA has granted Gemini Therapeutics a fast track designation for GEM103, an investigational treatment for dry, age-related macular degeneration (AMD). Gemini says it is evaluating the recombinant, human complement factor H (CFH) for its ability to address multiple AMD pathobiologies in genetically-defined subsets of AMD patients caused by
Drugs
FDA has granted RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex – a rare disease for which there is no FDA-approved first-line therapy. The company
Drugs
Teva says it appreciates FDA publication of the compliance policy for the quantity of bioavailability and bioequivalence samples retained under regulations. In a 1/5 comment letter, it notes that the requirement to have each reserve sample contain a sufficient quantity so that FDA can perform five times all the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that if FDA continues with a plan to post on a Web site a high-level summary of the agency’s review of REMS (risk evaluation and mitigation strategy) assessments, it should consider inviting applicants to review the summaries and discuss with
Drugs
FDA has granted priority review for AstraZeneca’s Farxiga (dapagliflozin) for treating new or worsening chronic kidney disease (CKD) in adults with and without Type 2 diabetes. The designation was based on clinical evidence from the DAPA-CKD Phase 3 trial showing Farxiga, on top of standard of care consisting
Drugs
FDA has deferred action on a Mylan/Biocon BLA for a proposed biosimilar of Genentech’s Avastin (bevacizumab). The agency accepted the BLA in 3/2020 with a planned action date of 12/27/20, according to a OneLive report. The delay reportedly came because FDA was unable to complete
Drugs
Nostrum Laboratories has recalled one lot of metformin HCl extended release tablets, USP 750 mg, because it was found to contain levels of nitrosamine impurities above FDA-approved limits. The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2
Drugs
FDA has released the FDA-483 issued following a 9/24-10/9/20 inspection at Stokes Healthcare, a Mount Laurel, NJ, outsourcing facility doing business as Epicur Pharma. The four observations on the form were: * failing to justify deviations from written production and process control procedures; * failing to have
Drugs
FDA has published a report, “Advancing New Alternative Methodologies at FDA,” to demonstrate the significant progress it says the agency has made in laying the groundwork for integrating alternative approaches into regulatory programs. The report was developed by the agency’s Alternative Methods Working Group, building upon the Predictive Toxicology
Drugs
FDA has published a draft guidance, Human Gene Therapy for Neurodegenerative Diseases, with recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. The document defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of
Drugs
FDA has lifted its partial hold on a Marker Therapeutics Phase 2 trial investigating the safety and efficacy of MAT-401, the company’s lead multi-tumor-associated antigen-specific T cell product candidate for treating post-transplant acute myeloid leukemia (AML). The company says the trial is evaluating the
Drugs
FDA says its review of a Web site and Facebook site maintained by Reddy Naturals, Kennesaw, GA, indicated that the company is selling several products that are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. A 12/18 Warning Letter quotes extensively from the company Web
Drugs
FDA has released the FDA-483 issued following a 3/16-3/20/20 inspection at OSO Biopharmaceuticals Manufacturing, an Albuquerque, NM, parenteral drug manufacturer. The two inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and * failure of written
Drugs
Bristol-Myers Squibb is shutting down its Opdivo (nivolumab) program to use the immuno-onology drug in treating newly-diagnosed brain cancer patients. Endpoints News reports that Opdivo plus standard-of-care temozolomide (Merck’s Temodar) plus radiation performed no better than placebo in extending overall survival in patients with
Drugs
HHS and the Defense Department have signed a $356 million contract with Merck for between 60,000 and 100,000 doses of its MK-7110, an immune system modifying antibody that the company recently acquired in its buyout of OncoImmune. The doses would be produced by this June. The administration
Drugs
Attorney Joanne Hawana (Mintz) says the most important thing FDA did in authorizing two mRNA Covid-19 vaccines at the end of 2020 was to be as transparent as possible. Writing in an online year-end review of FDA’s Covid drug and biologic activities, Hawana says the publicly available
Drugs
FDA has approved Amphastar Pharmaceuticals’ generic glucagon for injection, 1mg/vial packaged in an emergency kit, for treating severe hypoglycemia that may occur in patients with diabetes. An agency statement says the drug also is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel,
Drugs
FDA has sent Warning Letters to five companies selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. An agency notice says that the letters address illegal marketing of unapproved CBD products claiming to treat medical conditions. They include products that are especially concerning