Drugs
FDA has placed a partial clinical hold on a Blueprint Medicines early-stage trial testing experimental cancer drug BLU-222 because of safety concerns, according to a Reuters report. Some patients faced episodes of light sensitivity and blurred vision, the company says. The 366-participant drug dosing trial was initiated
Drugs
Takeda says it is beginning a Phase 3 trial by 6/30 of its narcolepsy Type 1 (NT1) drug TAK-861 after reporting positive results from a Phase 2b trial. Based on the data, the investigational oral orexin receptor 2 (OX2R) agonist has the potential to “provide transformative efficacy in
Devices
FDA has cleared a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system for the semi-quantitative detection of total IgE. Blood typically has small amounts of IgE antibodies, and higher amounts can signal the body is overreacting to allergens, Kenota Health says. The test
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Shanif Abdul Punjani for five years from importing or offering for import any drug into the U.S. The debarment is based on Punjani’s felony conviction for conspiracy to defraud the U.S. by importing thousands of Aurogra 100mg sildenafil
Drugs
FDA has extended by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The company said earlier this month that the agency recently requested sub-population breakdowns from the Phase
FDA Policy/General
Federal Register final rule: FDA is issuing a regulation to implement its authority to destroy a device valued at $2,500 or less that has been refused admission into the U.S. by providing to the owner or consignee a notice and an opportunity to appear and introduce testimony prior
Drugs
Gilead Sciences says it will be discussing with FDA the continued marketing of its accelerated-approval Trodelvy (sacituzumab govitecan-hziy) in patients with metastatic urothelial cancer following topline results from a Phase 3 confirmatory trial that showed the therapy did not meet the primary endpoint of overall survival (OS) in
Drugs
An FDA advisory committee briefing document shows reviewer concerns about safety and efficacy issues in a Lykos Therapeutics NDA for midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee is set to convene 6/4 to discuss the
Biologics
FDA has approved a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine for adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. Approval was based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in
Devices
FDA has approved an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device that is intended to harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects. “This next-generation device significantly reduces
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance “Platform Technology Designation Program for Drug Development.” The document provides details about implementing the agency’s Platform Technology Designation Program, which was established by the PREVENT Pandemics Act. It outlines eligibility factors for receiving a platform technology designation, potential benefits
FDA Policy/General
Federal Register notice: FDA is announcing its decision to terminate the Science Advisory Board to the National Center for Toxicological Research (NCTR), otherwise known as “the committee.” The agency says the advisory board was established in 1973, but it has met very infrequently over the past few years, adding that
Devices
Researchers at Yale and Emory Universities say there is little evidence that surrogate markers used by drug companies seeking accelerated approval coincide with better disease outcomes. The study (subscription or purchase required), published recently in the Journal of the American Medical Association, looked for meta-analyses for 37 surrogate markers
Drugs
FDA has approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. The. company says this is the fourth subtype
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The agency has set a 9/25 user fee review action target date. The submission is based on
Drugs
Attorney James Beck (Reed, Smith) says the 5th Circuit Court of Appeals issued 5/24 a “defense-friendly” decision in Hickey v. Hospira that reversed in large part a decision by a Louisiana federal court. Beck says the appeals court applied the same implied preemption analysis to Section 355(b)
Drugs
FDA has denied a 4/2019 Novartis petition asking the agency to take specified steps regarding ANDAs that reference the company’s Entresto (sacubitril and valsartan tablets). The agency’s 5/28 denial letter says Novartis asked FDA to: * require ANDAs that reference Entresto to demonstrate active ingredient sameness based
Devices
OptumHealth Care Solutions is recalling (Class 1) its Nimbus II Plus infusion pumps (also known as the Nimbus II Optum Homecare Infusion) in response to a 2/21 InfuTronix recall of these devices due to multiple potential failure modes that may include battery failure, upstream blockage, system errors, drug product
FDA Policy/General
FDA says its proposed reorganization involving changes in the functioning of the Office of Regulatory Affairs, with a new model for field operations, the creation of a unified Human Foods Program, and other efforts has been approved. An agency notice says implementation of the reorganization is targeted for 10/1.
Drugs
CDER Office of Medical Policy director Khair ElZarrad says the use of artificial intelligence (AI) in drug regulatory submissions has seen a rapid increase in recent years. Interviewed on a Q&A with FDA podcast, ElZarrad said that from 2016 to 2024, some 300 submissions were received that reference
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Maria Anzures-Camarena from providing services in any capacity to any person/entity that has an approved or pending drug product application. FDA bases the order on Anzures-Camarena’s recent guilty plea regarding her involvement in a conspiracy with
Drugs
Federal Register notice: FDA is withdrawing approval of three NDAs from multiple applicants after they notified the agency that the products were no longer marketed and requested their withdrawal. The products are: * Bayer Healthcare’s Cipro in Dextrose 5% in plastic container (ciprofloxacin) Injectable, 200 mg/100 mL and 400