Biologics
FDA has asked Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. “The FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/2026. To view the notice, click here.
Devices
FDA has approved Inspire Medical Systems’ Inspire V therapy system which includes the next generation neurostimulator and an associated Bluetooth patient remote and physician programmer for treating sleep apnea. Inspire’s implant is designed to deliver gentle pulses to airway muscles to keep the airway open so patients can breathe
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies: Questions and Answers.” The International Council for Harmonization-prepared main document provides general recommendations on evaluating the enzyme and transporter- mediated pharmacokinetic drug-drug interaction potential
Drugs
FDA has granted Adaptimmune accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and
Drugs
FDA has granted Cellectis an orphan drug designation (ODD) for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). “The importance of adding alemtuzumab to a lymphodepletion regimen has been demonstrated in Cellectis’ BALLI-01 study, where the addition of this lymphodepletion agent to
Devices
FDA has cleared a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty (UKA). The expanded indication builds upon the previously cleared VELYS Robotic-Assisted Solution platform used in total knee arthroplasty, the company says. “The UKA application is designed for both
Drugs
FDA has approved an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). The company says AFD often results from severe bleeding and can weaken blood clot formation, increasing hemorrhage risk in patients. The
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.” The collection is intended to support scientific research to address emerging data on kratom and psychedelics suggesting
Drugs
CDER has posted a revised guidance agenda for calendar year 2024. The agenda lists 101 new, revised draft, and immediately effective guidances in these 17 categories: Administrative/Procedural (11), Biosimilars (4), Clinical/Antimicrobial (1), Clinical/Medical (20), Clinical Pharmacology (1), Compounding (7), Drug Development Tools (1), Drug Safety (3), Generics
Drugs
FDA has published an International Council on Harmonization (ICH) guidance, M12 Drug Interaction Studies Questions and Answers, to respond to questions posted to the ICH draft guidance comment period. The document says it was developed to provide clarity around some of the concepts related to the evaluation of drug interactions
Drugs
Sens. Dick Durbin (D-IL) and Bill Cassidy (R-LA) have introduced the bipartisan Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act to promote competition by removing FDA barriers to approving lower-cost generic drugs. In a statement, Durbin says the bill responds to some efforts by the
Devices
FDA has cleared a Teleflex 510(k) for its Ringer Perfusion Balloon Catheter (PBC) for use in percutaneous transluminal coronary angioplasty (PTCA) procedures. The device is described as a rapid-exchange 0.014 inch compatible catheter with a helical balloon at its working end. “When inflated, this balloon approximates a
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/4/2026. To view the notice, click here.
Drugs
FDA researchers are using an open-source article in Drug Safety to introduce LabelComp, an artificial intelligence (AI) tool that automates the identification of changes in adverse event terms made during drug labeling updates. The article says that traditional methods of updating drug labeling with new adverse event information have
Drugs
FDA has approved an sBLA for GlaxoSmithKline’s Jemperli (dostarlimab) with carboplatin and paclitaxel followed by Jemperli as a single agent to treat adults with primary advanced or recurrent endometrial cancer. A company statement says the approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch
Drugs
Abbott has initiated a medical device correction for a “small number” of FreeStyle Libre 3 sensors because they may provide incorrect high glucose results. The affected devices were distributed in the U.S. during the first half of May, the company says. FreeStyle Libre 3 includes a sensor, reader and
Drugs
Novartis has filed a lawsuit against FDA that seeks to reverse the agency’s recent approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure. Novartis argues that FDA’s conduct
Drugs
FDA has issued Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imaging agent for clear cell renal cell carcinoma. “During the 60-day administrative review, the FDA has identified a filing issue in the chemistry, manufacturing and controls (CMC) package,
Drugs
A Texas federal grand jury has indicted Sanjay Kumar of Bihar, India, on charges of selling and shipping tens of thousands of dollars worth of counterfeit cancer drugs into the U.S. A Department of Justice statement says Kumar and his co-conspirators allegedly arranged for the sale and shipment
Drugs
The CDER Quantitative Medicine Center of Excellence (QM CoE), which opened 3/25 to foster the integration of quantitative methods across CDER and help advance therapeutic medical product development and inform regulatory decision-making, says it has new resources available. The resources are: * a quick reference Fact Sheet with a
FDA Policy/General
Federal Register notice: FDA is announcing biosimilar user fee rates for fiscal year 2025. They are: * Applications requiring clinical data — $1,471,118 * Applications not requiring clinical data — $735,559 * Biological product development program fee — $256,168 To view the notice, click here.