Drugs
In what looks to be a common occurrence in the wake of recent downsizing and the subsequent departure of its leadership, FDA has now missed a 5/7 user fee review action target date for a GSK supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance
Drugs
The FDA Office of Inspections and Investigations (OII) Ombudsman Program recommends that the agency explore developing a Stakeholder Education Hub, perhaps as a dedicated Web page that brings together existing educational resources organized around common concerns in a question-and-answer format. The recommendation is included in the program’s
Drugs
FDA has granted Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera (PV), a rare hematologic cancer. Givinostat is an orally administered histone deacetylase inhibitor (HDACi)with potential applications in both neuromuscular disorders and oncology, according to the company. “HDACis work by modulating key cellular pathways
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
Drugs
A northern Texas judge has ruled in FDA’s favor in a case challenging its decision last year to remove Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro from its drug shortage listing, a move that ultimately made it illegal for compounding pharmacies to produce large quantities
Drugs
FDA has accepted for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The resubmission has been assigned a user fee review action target date of late September. In 2021, FDA issued a complete response letter on the BLA, saying it
Drugs
FDA is announcing a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions. During the morning session on 5/20, panel members will discuss a supplemental BLA for Genentech’s Columvi (glofitamab) injection and its use in combination with gemcitabine
FDA Policy/General
FDA associate commissioner for inspections and investigations Michael Rogers, who has worked for the agency for more than 30 years, is retiring effective 5/14, reportedly over staff frustration with commissioner Martin Makary. “I have decided to retire,” Rogers told CBS News. “It was my decision, but it was time
Drugs
FDA says it will expand unannounced inspections at foreign manufacturing facilities that produce medical products, drugs, and food intended for U.S. consumers and patients. A 5/6 statement says the intent is to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic
Drugs
President Donald Trump signed 5/5 an Executive Order directing FDA to cut the amount of time it takes to approve domestic drug manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with domestic manufacturers to provide early support before facilities come online. “We don’t want
Drugs
FDA has approved an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults. Chlorthalidone, a thiazide-like diuretic, has been approved and marketed over several decades, and until now, only higher-dose chlorthalidone tablets (25 mg and 50 mg) have been available
Drugs
A 2/12-2/16/2024 FDA Bioresearch Monitoring Program inspection at Amicis Research Center, operated by Dr. Nana Barseghian in Northridge, CA, found that Barseghian failed to ensure that a clinical investigation was conducted according to the investigational plan. A 4/28 Warning Letter acknowledges the corrective and preventive
Drugs
The Trump administration 5/5 asked a federal judge to dismiss a lawsuit filed by Idaho, Kansas, and Missouri that seeks to block access to the abortion pill mifepristone via telehealth. In court filings, attorneys for the Department of Justice (DoJ) maintained the legal strategy established under the Biden administration,
Drugs
Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is evaluating it for treating X-linked retinitis pigmentosa (XLRP). The company describes XLRP as a genetic eye disease, which primarily affects males, caused by a defect in the RPGR
Drugs
A new report from IQVIA says drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with a 4.9% increase in 2023. “Greater use of medicines with significant clinical benefits is driving spending growth, while net price growth is flat,” the report
Drugs
Researchers from Genentech find that FDA’s Drug Development Tools (DDTs) Qualification program has had a very “limited” impact on development programs. Writing in an online post on physiciansweekly.com, the researchers note that the DDT pathway for evaluating clinical outcome assessments (COAs) gets bogged down and takes longer for
Drugs
Public health researchers are warning about the broader impact to emerging technologies in a March ruling (see story) by a Texas federal judge that struck down FDA’s final rule establishing a regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs). Writing in a 5/5
Drugs
Capricor Therapeutics says it has completed an FDA mid-cycle review meeting for a BLA seeking approval for deramiocel and its use in treating Duchenne muscular dystrophy (DMD) cardiomyopathy. “During the meeting, FDA stated that no significant deficiencies have been identified by the review committee and that the package is
Drugs
FDA has accepted for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in obese adults or those who are or overweight with one or more comorbid conditions, and to reduce the risk of major adverse cardiovascular events (MACE)
Drugs
FDA Office of Scientific Integrity director George Warren has issued a scheduling order on Vanda Pharmaceuticals’ request for a hearing on CDER’s proposal to refuse to approve the company’s NDA for its gastroparesis drug tradipitant. In the order, Warren notes that CDER had requested until 9/12 to
Drugs
In a Phase 3 trial funded by Novo Nordisk, patients receiving a weekly dose of 2.4 mg of semaglutide (the company’s Ozempic and Wegovy), a glucagon-like peptide-1 receptor agonist, had better results regarding steatohepatitis and fibrosis in metabolic dysfunction-associated steatohepatitis than patients receiving placebo. The
FDA Policy/General
FDA staff reductions in force appear to be hurting programs that track drug safety, according to anonymous sources who spoke with Chemical & Engineering News. A fired employee told the newsletter that “there’s a handful of employees desperately keeping the lights on.” The report says the CDER Division of