Drugs
As required by the PDUFA 7 reauthorization agreement, FDA has issued its draft strategy document outlining the specific actions it will take over the course of PDUFA 7 (2023-2027) to facilitate the use of innovative manufacturing technologies, including addressing barriers to their adoption. The document says the actions are
Drugs
The Washington, DC District Court 9/10 dismissed as not ripe for review a Vanda Pharmaceuticals lawsuit against FDA that challenged the agency’s bioequivalence determination of a generic competitor to sleep drug Hetlioz, calling it arbitrary and capricious, in violation of the Administrative Procedure Act (APA). Vanda argued that
Drugs
FDA says a confirmatory trial for Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid), which received accelerated approval on 5/27/2016 to treat primary biliary cholangitis (PBC) in conjunction with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate
Drugs
A 4/15-4/23 FDA inspection at the Zydus Lifesciences Limited drug manufacturing facility in Taluka, Waghodia, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/29 Warning Letter says specific violations were: * failure to thoroughly investigate any unexplained discrepancy or
Drugs
The Medical Information Working Group (MIWG) says it has concerns about a revised FDA question-and-answer draft guidance on addressing misinformation about medical devices and prescription drugs. In its comment, the MIWG says that despite improvements made in the current revision, it still has concerns about the guidance’s
Drugs
FDA is considering more opportunities for sponsors to learn about inspection issues that arise during pre-approval/pre-licensure inspections before an application review is completed. Speaking at a joint Parenteral Drug Association/FDA regulatory conference in Washington, DC 9/9, CDER director Patrizia Cavazzoni acknowledged that there is a
Drugs
Attorneys Wyatt Kernell and Sonia Nash (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in
Drugs
GSK says data from its SWIFT-1 and SWIFT-2 Phase 3 clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation. The findings were presented at the 9/9 European Respiratory Society International Conference in Vienna and published simultaneously in the New England
Drugs
FDA has removed a partial clinical hold against Rezolute’s RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism. (HI) Ersodetug is currently being evaluated in the sunRIZE global Phase 3 study in participants with congenital HI, the company says, and the hold removal will permit it to
Drugs
FDA has granted Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The therapy received accelerated approval 2/23 based on the surrogate marker of proteinuria. Full approval, the company says, is
Drugs
GSK says “headline” results from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug (COPD) Nucala (mepolizumab) met its primary endpoint — “statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.” The monoclonal
Drugs
FDA has issued Regenerative Processing Plant a Warning Letter based on a 6/2023 inspection of the firm’s Palm Harbor, FL, manufacturing facility that found significant GMP violations involving its ophthalmic drug products, Regener-Eyes Professional (PRO) Ophthalmic Solution and Regener-Eyes LITE Ophthalmic Solution. Based on claims being
Drugs
An April inspection of Taenaka Kogyo (Mobara, Chiba, Japan) has resulted in a four-observation Form FDA-483 that cites significant GMP violations. For example, the agency says the firm’s training was not regularly conducted by qualified individuals, and it did not cover the operations the employees performed. The
Drugs
The Department of Justice says Glenmark Pharmaceuticals, a generic drug manufacturer based in Mahwah, NJ, has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of generic pravastatin (Pravachol). A department statement
Drugs
Eli Lilly says data from its QWINT-1 and QWINT-3 Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes showed non-inferiority A1C reduction compared to the most frequently used daily basal insulins. The trials evaluated the therapy in patients using basal
Drugs
An Associated Press analysis of FDA records shows that agency inspectors have not returned to some 2,000 drug manufacturing firms to conduct surveillance inspections since before the 2019 Covid-19 pandemic. An AP report says the firms that are overdue for inspections represent about 42% of the 4,700
Drugs
The FDA Antimicrobial Drugs Advisory Committee will consider 9/9 a resubmitted Iterum Therapeutics NDA for sulopenem etzadroxil/probenecid, an oral treatment for uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women. An agency briefing document released in advance of the meeting says the committee is to
Drugs
Biosimilars advocacy group Biosimilars Forum is asking FDA for further information and clarification on certain areas of the agency’s recent draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products.” Regarding the scope of the guidance, Biosimilars Forum says in just-
Drugs
FDA has published a guidance, Control of Nitrosamine Impurities in Human Drugs, to recommend steps that manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine
Drugs
The Association for Accessible Medicines (AAM) says it recognizes that the International Council for Harmonization M14 draft guidance on general principles on plan, design, and analysis of pharmacoepidemiological studies that use real-world data for safety assessment of medicines “includes recommendations and high-level best practices for the conduct of
Drugs
FDA says its review of a Web site maintained by SoloVital in Chula Vista, CA, found that the company markets Umary Hyaluronic Acid, an unapproved new drug, in the U.S. An 8/27 Warning Letter says an FDA analysis determined that a sample of the company’s Umary contains
Drugs
The Department of Justice says Paul Lamberty of Folsom, CA, pleaded guilty in a Massachusetts federal court to one count of conspiracy to defraud the United States and one count of the introduction of misbranded drugs with the intent to defraud and mislead. A department statement says Lamberty operated Web