Drugs
The Government Accountability Office (GAO) says that since FDA established the limited population pathway for antibacterial and antifungal drugs (LPAD) in 2016, drug developers have formally requested approval under it for four drugs, two of which were approved. In a report, GAO says FDA and stakeholders agreed that LPAD’s
Drugs
Research conducted by FDA scientists will inform efforts to improve pediatric dose selection strategies for drug developers and pediatricians who must pay particular attention to renal function. An online agency post says renal function models and equations are valuable tools for predicting drug pharmacokinetics, clearance, and dose adjustments in pediatric
Biologics
The House Select Committee on the Coronavirus Crisis is asking former FDA commissioner Stephen Hahn for information relating to possible political interference from the Trump administration in the pandemic response. In an 11/22 letter, the committee asks Hahn for all documents and communications in his possession, custody, or control
Drugs
FDA has granted Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate ([6R]-MTHF) for treating patients with metastatic colorectal cancer. Arfolitixorin is designed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. It is currently being studied
Drugs
Four Sidley attorneys say an FDA draft guidance on benefit/risk assessment for new drugs and biological products “is [so] groundbreaking in its articulation of a vision of drug development that many entities involved in developing innovative drugs and biological products should review it carefully.” In an online post, the
Drugs
FDA has accepted for priority review a bluebird bio BLA for betibeglogene autotemcel (beti-cel), a gene therapy for adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions. If approved, beti-cel would be a one-time treatment that addresses
Drugs
FDA has accepted for review an Obseva NDA for linzagolix for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Linzagolix is described as an GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot
Drugs
FDA appears to be making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that were delayed due to the Covid-19 pandemic. In May, the agency released its “Resiliency Roadmap for FDA Inspectional Oversight” report (see earlier story) that said 68
Drugs
FDA has released the Establishment Inspection Report (EIR) associated with a complete response letter issued to Revance Therapeutics on its BLA for daxibotulinumtoxinA for injection and its use in treating moderate to severe glabellar (frown) lines. The EIR recommended that the agency withhold approval of the BLA due to the
Drugs
FDA 11/19 amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech Covid-19 vaccines to allow a booster dose for all individuals 18 years of age and older. Prior to this action, booster shots were authorized for individuals 65 years of age and older, individuals
Drugs
Heron Therapeutics says it has submitted an NDA for its HTX-019 (aprepitant) injectable emulsion indicated for preventing postoperative nausea and vomiting (PONV) in adults. A company statement says HTX-019 is a proprietary intravenous formulation of aprepitant that is approved for PONV prevention. The injectable emulsion formulation intended for
Drugs
FDA has approved a new indication for Merck’s Keytruda for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The company says the approval is based on data from the pivotal Phase
Drugs
FDA says its pharmacists are available to help consumers achieve the best possible outcome when taking drugs. An online post says agency pharmacists are available by telephone or e-mail to answer a variety of questions. “Call your local pharmacist or FDA’s drug information pharmacists if you have questions
Drugs
FDA says that since drug manufacturers should have completed a nitrosamine impurity risk assessment based on the timetable in a 2/2021 guidance, it is giving companies additional points to consider in developing their nitrosamine mitigation strategies that are due 10/1/2023. An online update says the agency has
Drugs
FDA has approved the resumption of enrollment in an AB Science Phase 3 confirmatory study of masitinib in patients with amyotrophic lateral sclerosis (ALS). A company announcement says the study is actively enrolling in 15 countries in Europe, the U.S., and other regions. The study has three parallel groups
Drugs
A Public Citizen petition calls on FDA to disqualify two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” The advocacy group says the doctors conducted a series of clinical trials that tested the general anesthetic ketamine and powerful
Drugs
FDA has granted fast track designation for Zentalis Pharmaceuticals’ ZN-c3, an oral WEE1 inhibitor product candidate for the treatment of recurrent or persistent uterine serous carcinoma in adult women. The company says ZN-c3 is a potentially first-in-class and best-in-class oral inhibitor of WEE1 in
Drugs
The Alzheimer’s Association is providing seed money to launch a new National Treatment and Diagnostic Alzheimer’s Registry. The advocacy organization says the registry will be an “FDA-approved agent agnostic approach to gathering routine clinical practice data and outcomes for sharing quickly and transparently with all stakeholders.” The
Drugs
Two Wiley Rein attorneys say a proposed FDA requirement to report the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act represents a big change for many companies that have not had to report distribution data to the agency.
Drugs
SterRx has recalled 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance. To date, SterRx has not received reports of any product complaints or adverse events associated with the issue. Affected products are: * lmg/
Drugs
CytoDyn has begun resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for highly treatment-experienced HIV patients. Last year, FDA issued CytoDyn a refusal to file letter on its BLA because the submission did not contain certain information needed to
Drugs
FDA says that under the Model-Informed Drug Development (MIDD) pilot program, it is asking the MIDD meeting requests and meeting packages to include elements of a credibility framework to facilitate alignment and streamline review. The MIDD pilot is being conducted to facilitate the development and application of exposure-based,