Drugs
FDA is making available a final guidance entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The document was developed as part of the agency’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in
Drugs
FDA has issued Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treating moderate-to-severe atopic dermatitis (eczema). The agency letter cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturer, according to the company. The
Drugs
CDER’s Office of Generic Drugs has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations in their ANDAs. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the
Drugs
FDA has approved a Novo Nordisk NDA for Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference therapy for lowering urinary oxalate levels in children nine years of age and older and adults with primary hyperoxaluria Type 1 and relatively preserved kidney function. The rare genetic disease causes overproduction
Drugs
Novartis says it will seek accelerated approval next year for its IgA nephropathy (IgAN) drug iptacopan after announcing “positive top-line results” from a planned interim analysis of the Phase 3 APPLAUSE-IgAN study (NCT04578834) at nine months. “Iptacopan, an investigational factor B inhibitor targeting the alternative complement pathway, demonstrated
Drugs
As of Friday (9/29) evening, the ongoing Congressional budgetary impasse is on course to trigger a government shutdown this weekend. House Speaker Kevin McCarthy seems to lack the necessary votes to pass a short-term continuing resolution to keep government agencies like FDA fully running after 9/30 while
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
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
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,
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
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
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-
Drugs
Nephron Pharmaceutical appears to be under a continuing microscope at FDA after an inspection earlier this year resulted in a just-posted 15-item Form FDA-483 that cites numerous GMP deficiencies. The inspection came on the heels of a 10/2022 Warning Letter that cited several GMP issues and
Drugs
FDA has granted Ideaya Biosciences a Fast Track designation for IDE161, which it describes as a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG) for treating adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum-resistant and have