Drugs
FDA has published a final guidance, “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding,” with recommendations to assist applicants in incorporating information into proposed prescription drug labeling under specified conditions. The document applies to situations
Biologics
FDA has approved a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody referencing Genentech’s arthritis drug Actemra. Tofidence is approved for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. FDA approval of Tofidence was based on
Drugs
CDER’s Office of Generic Drugs (OGD) is expanding its post-pandemic return to in-person face-to-face (FTF) meetings with industry. Beginning 10/2, OGD will add the following meetings to the current FTF meeting option for the pre-ANDA product development and pre-submission meetings: * pre-submission
Drugs
FDA has announced a new pilot program to “further accelerate the development of novel drug and biological products for rare diseases.” A limited number of selected participants will test the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program and its ability to offer frequent advice and regular
Devices
FDA has published a guidance, Antimicrobial Susceptibility Test (AST) System Devices — Updating Breakpoints in Device Labeling, with information about updating susceptibility test interpretive criteria (STIC) breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized
Devices
FDA has published a draft guidance, Electronic Submission Template for Medical Device De Novo Requests, to introduce de novo request submitters to the current resources and associated content developed and made publicly available to support de novo electronic submissions to the agency. The document says it “is intended to represent
Drugs
Three individuals have submitted a petition to FDA asking that the agency add language from the fluoroquinolone Boxed Warning to the top of the Medication Guide for all such antibiotics. The petition says the change would address the Boxed Warning that serious adverse reactions including tendonitis, tendon rupture, peripheral neuropathy,
Biologics
FDA’s Cellular, Tissue, and Gene Therapy Advisory Committee 9/27 voted 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenchymal stem cell therapy for treating amyotrophic lateral sclerosis (ALS, and also known as Lou Gehrig’s Disease). Panel members mostly agreed with FDA
Drugs
FDA has approved a subcutaneous (SC) administration device (single-dose pre-filled pen) for Takeda’s Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis after induction therapy with Entyvio intravenous. The drug was originally approved in 2014 for treating adult patients with moderate to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Adverse Experience Reporting For Licensed Biological Products; and General Records — 21 CFR Part 600.” The collection supports the agency’s regulatory authorities that govern adverse experience reporting after a biological product is approved and enters the market.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Applications for FDA Approval to Market a New Drug — 21 CFR Part 314.” The revision applies to Form FDA-3938 and accompanying instructions on submitting drug master files to allow for multiple selections of submission types and
Drugs
FDA has approved an Amicus Therapeutics NDA for Pombiliti (cipaglucosidase alfa-atga) in combination with Opfolda (miglustat) 65mg capsules for treating adults living with late-onset Pompe disease weighing more than 40 kg and who are not improving on their current enzyme replacement therapy (ERT). Amicus says the rare, life-
Drugs
A Reuters analysis of FDA adverse event data indicates that since 2010 the agency has received 265 reports of suicidal thoughts or behavior in patients taking GLP-1 receptor agonist drugs such as Novo Nordisk’s Ozempic (semaglutide) and Wegovy (semaglutide) and Lilly’s Mounjaro (tirzepatide). The news service says
Devices
FDA has published a guidance, Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, to ensure safe and effective use and provide recommendations for the content of premarket submissions. The document says Physiologic Closed-Loop Control (PCLC) technology “can enable automation in a variety of medical device types.
Biologics
FDA has published a draft guidance, Graft-versus-Host Disease: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment, to assist sponsors in developing such products. Specifically, the document addresses the agency’s current thinking about the overall clinical development program and critical design elements for early- and
Drugs
FDA has approved a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major depressive disorder in adults. Exxua features a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion, according to the company. In clinical trials,
Drugs
FDA has approved a new indication for Pfizer’s Bosulif (bosutinib) for pediatric patients age one and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. The agency says it also approved a new capsule dosage form available in 50
Drugs
FDA has approved Novo Nordisk’s labeling changes for Ozempic (semaglutide), a drug indicated to treat Type 2 diabetes that has become popular for weight loss, to add reports of ileus (blocked intestines) following use of the medication. CBS News reports that labeling for Novo Nordisk’s Wegovy (semaglutide) and
Drugs
Gilead Sciences has ended its ENHANCE-2 trial of magrolimab in acute myeloid leukemia (AML) with TP53 mutations. A company statement says that based on an ad hoc analysis and following review by an independent data monitoring committee, Gilead concluded that magrolimab is unlikely to demonstrate a survival benefit in
Drugs
Sens. Markwayne Mullin (R-OK) and Cory Booker (D-NJ) have introduced the Prescription Information Modernization Act that would enable FDA to implement a rule that allows drug manufacturers to transmit prescribing information electronically to reduce waste, improve efficiency, and ensure that healthcare professionals have access to the latest drug
Drugs
FDA has approved a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically-induced mydriasis (dilation) produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. The companies say about 100 million eye exams are conducted each year that involve pharmacologically-
Devices
FDA has cleared a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined platform that enhances the intravascular imaging and physiology experience. It is intended to integrate best-in-class percutaneous coronary intervention (PCI) guidance tools into one system, “so users