Drugs
FDA has approved Corium’s Adlarity (donepezil transdermal system) to treat patients with mild, moderate, or severe dementia of the Alzheimer’s type. The company says it is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood
Drugs
The drug industry lobbying arm Pharmaceutical Research and Manufacturers of America told a House Energy and Commerce Committee hearing 3/17 that proposed reforms to the accelerated approval program are not needed and that it is concerned with any FDA-related policy proposals and legislative riders being added to negotiated
Biologics
Moderna has submitted an Emergency Use Authorization (EUA) amendment to permit an additional Covid-19 vaccine booster (fourth dose) in adults 18 years of age and older who have received an initial booster of any of the authorized or approved vaccines. “The request to include adults over 18 years of
Drugs
Merck says new data from the pivotal Phase 3 KEYNOTE-091 trial found that adjuvant treatment with Keytruda significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo in patients with stage IB to IIIA
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently marketed and covered by a subsequent EUA. To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original 351(a) Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in
Drugs
FDA says its reviews of a Web site and social media sites maintained by Iotech International, Boca Raton, FL, determined that the company is selling ioRinse and ioCleanse in the U.S., saying they are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 3/15
Devices
An FDA safety communication alerts people that there is a potential for harm if authorized at-home Covid-19 tests are not used according to the manufacturer’s test instructions. The online document also reminds people to keep the tests out of reach of children and pets. “Incorrect use of
Devices
FDA has granted an emergency use authorization for an Indicaid Covid-19 over-the-counter at-home rapid antigen test. An agency statement (contains a link to the emergency authorization document) says the test delivers results in 20 minutes. The test can be used as (1) a single test for
Drugs
FDA has approved Marinus Pharmaceuticals’ Ztalmy (ganaxolone) oral suspension to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy in patients age 2 and older. The company says it is the first FDA-approved treatment specifically in CDD. Ztalmy’s approval
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
Drugs
An FDA analysis finds a first-cycle approval rate of 13% for modified release tablet ANDAs submitted between 2017 and 2019. “Deficiencies identified in multiple review disciplines are responsible for the low first-cycle approval rate,” a CDER chart says. “Most of the cited manufacturing process-related deficiencies are unit
Biologics
There are several decisions facing new FDA commissioner Robert Califf over the next few months that will give insight into his thinking, according to a Barron’s article (subscription required). The article identifies and describes these issues: * Amylyx Pharmaceuticals’ experimental ALS therapy AMX0035 could put the agency into another Biogen
Drugs
FDA is planning several pilot programs to test ways to improve foreign inspections, agency staff have told Bloomberg Law. For an online story, Bloomberg talked to several attorneys about the foreign inspection program and the need for improvements. The attorneys said that increasing agency staff, using unannounced inspections, and hiring
Drugs
FDA has denied the substantive portions of a Novartis Gene Therapies 12/17/21 due diligence petition asking that the agency determine that Regenxbio did not act with due diligence during the regulatory review period of Zolgensma (onasemnogene abeparvovec-xioi) for purposes of patent term extension. The agency response says
Drugs
FDA has granted fast track designation for 7 Hills Pharma’s 7HP349, its lead clinical-stage immunosuppressant in combination with a CTLA-4 inhibitor to treat patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor. The company says 7HP349 is designated as an oral
Drugs
FDA and the Reagan-Udall Foundation are hosting a 3/29 virtual public workshop to discuss “critical questions” around access to naloxone and its use to reverse opioid overdoses. “An integral part of our efforts to combat opioid-related drug overdose is making naloxone more readily available and accessible,” CDER
Devices
University of California San Francisco researchers say that since the implementation of the 21st Century Cures Act, which directed FDA to consider the role of post-market information in determining the least burdensome means for approval, there has been no significant increase in the frequency of FDA post-approval study
Drugs
FDA has granted Myrtelle a Fast Track, Rare Pediatric Disease, and Orphan Drug designations for its lead clinical-stage gene therapy, rAAV-Olig001-ASPA, for treating patients with Canavan Disease. The condition is a fatal childhood genetic brain disease in which mutations in the Aspartoacylase gene (ASPA) prevent normal Aspartoacylase
Drugs
FDA has given the green light to Kairos Pharma to begin a clinical trial of its activated T cell therapy (KROS 201) in patients with recurrent glioblastoma, a type of brain cancer. The Phase 1 trial will be conducted at Cedars Sinai Medical Center in Los Angeles. KROS 201 activated
FDA Policy/General
Federal Register notice: FDA is seeking comments on its draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange” for electronically submitting PQ/CMC data. The document provides a draft design of Health Level 7 (HL7) “Fast Health Interoperability Resources” (FHIR) profiles that contain the data elements and terminologies
Drugs
FDA has released the FDA-483s issued following two 3/22-4/2/21 inspections at WuXi Biologics Co., a WuXi, Jiangsu, China, drug substance and drug product manufacturer. The first FDA-483 has these five observations: * failing to exercise appropriate controls over computer or related systems to prevent changes