Drugs
FDA has expanded CDER’s NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions under section 505G of the Federal Food, Drug, and Cosmetic Act. “Requests for formal meetings between FDA and sponsors and requestors of OTC monograph drugs and related meeting correspondence (e.g., meeting packages)
Drugs
FDA has added important information to the emergency authorization of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals about the increased risk for developing Covid-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. The agency says
Drugs
FDA has posted a draft guidance entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA” that introduces an enhancement under the reauthorized generic drug user fee program that became effective 10/1. The document is intended for holders of Type 2 active pharmaceutical ingredient (API)
Drugs
BioMarin has resubmitted its BLA for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A. The resubmission includes the company’s response to a 2020 complete response letter and subsequent agency feedback, including two-year outcomes data from the global GENEr8-1 Phase 3 study and supportive data from
Drugs
More than one-third of accelerated approval drugs (104 of 278 between 1992 and 2021) are past their confirmatory trials’ original planned completion dates, including four that are more than five years past those dates, an HHS Inspector General (IG) data snapshot says. The snapshot is part on an ongoing
Drugs
East Windsor, NJ-based Eugia U.S. (formerly AuroMedics Pharma) has recalled one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a product complaint about the presence of a dark red, brown and black particulate inside a vial. “The administration of an intravenous
Drugs
FDA says manufacturing-related deficiencies contribute significantly to a low rate of ANDA approvals for modified-release tablet products during the first review cycle. Writing in the 9/28 issue of the journal AAPS PharmSciTech, CDER researchers said only 12% of such products were approved first cycle between fiscal years
Drugs
The National Institutes of Health (NIH) says the Accelerating Medicines Partnership (AMP) Heart Failure program, which includes FDA among its members, has launched. The program is focused on heart failure with preserved ejection fraction (HFpEF) and is investigating the multiple factors that lead to HFpEF, seeking to determine the phenotypes
Drugs
FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for treating adult patients with prurigo nodularis, a chronic, debilitating skin disease with underlying Type 2 inflammation. Approval was based on data from two Phase 3 trials, PRIME and PRIME2, that assessed the proportion of subjects with clinically meaningful reduction in itch, clearing
Drugs
Pharmaceutical Research and Manufacturers of America suggests several ways FDA could improve its draft guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments. The association’s comment letter calls for changes to expand the guidance’s scope and provide consistency in terminology across the agency’s patient-
Drugs
The Senate unanimously passed 9/29 the bipartisan FDA Modernization Act 2.0 (S. 5002), introduced by Sens. Rand Paul (R-KY) and Cory Booker (D-NJ). A statement (contains a link to the bill) issued by Paul says the legislation “ends an outdated FDA mandate that experimental drugs must
Drugs
FDA has approved Amylyx’s amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol). The agency green light comes after an unprecedented second advisory committee vote within six months reversed its earlier negative recommendation to back the drug in a 7
Drugs
FDA has released the form FDA-483 issued following a 5/10-5/20 inspection at the Delta Pharma outsourcing facility in Ripley, MS. The inspection observations were: * clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform; * aseptic processing areas are
Drugs
Eisai and Biogen say the Phase 3 confirmatory Clarity AD trial of their lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology, successfully met all primary and secondary endpoints.
Drugs
Researchers at the University of California San Francisco say their review of 15 oncologic drug surrogate outcome analyses published by FDA from 2005 to 2002 found that the vast majority of the analyses did not find strong correlations between a surrogate outcome and overall survival. In fact, they say, of
Drugs
FDA has issued Avidity Biosciences a partial clinical hold on new participant enrollment in its Phase 1/2 MARINA clinical trial of AOC 100, an antibody oligonucleotide conjugate, in adults with myotonic dystrophy Type 1 (DM1). Close to 40 participants are currently enrolled in the MARINA and MARINA open label
Drugs
PTC Therapeutics says the International Council for Harmonization M12 draft guidance on drug interaction studies provides general guidelines on how to design, conduct, and interpret drug-drug interaction studies during the development of a therapeutic product. In a comment letter, PTC makes suggestions and seeks clarifications on ICH harmonized guidelines
Drugs
FDA has published a draft guidance, Providing Over-the-Counter Monograph Submissions in Electronic Format, to assist submitters by describing the electronic over-the-counter electronic submission requirement in section 505G(j) of the Federal Food, Drug, and Cosmetic Act, which was added by the Coronavirus Aid, Relief, and Economic
Drugs
A 2/28-3/4 FDA inspection at Zhejiang Tianyu Pharmaceutical Co., Zhejiang Sheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 8/17 Warning Letter says the specific deviations were: * failing to extend investigations to other batches that
Drugs
Five researchers in CDER’s Office of Clinical Pharmacology say that “leveraging clinical pharmacology principles during drug development and evaluation can fulfill knowledge gaps and help the right patient receive the right drug, at the right dose, at the right time.” Writing in Clinical and Translational Science, the researchers say
Drugs
Rep. A. Donald McEachin (D-VA) has introduced the Updated Drug Labeling for Patient Safety Act to direct FDA to allow generic drug manufacturers to update their product labeling with safety-related information. A statement from McEachin says his bill would direct the agency to: * issue a final rule establishing
Drugs
FDA researchers from several disciplines say the use of pediatric extrapolation since 2015 “continues to be expanded and refined. As scientific evidence increases the knowledge and understanding for any given disease and therapeutic response, reevaluation of the optimized use of pediatric extrapolation should be considered during drug development.” Writing in