Biologics
FDA has told BioMarin Pharmaceutical that it no longer plans to hold an advisory committee meeting to review the company’s resubmitted BLA for Roctavian (valoctocogene roxaparvovec AAV gene therapy), indicated for adults with severe hemophilia A. The agency’s decision comes on the heels of its request earlier this
Devices
FDA says the Baxter Hillrom 9/30 recall of 8,550 WatchCare Incontinence Management Systems due to a risk of RF interference with nearby medical equipment is Class 1. An agency notice says the recalled units were distributed between 8/1/2018 and 9/1/2022. Baxter Hillrom recalled the
Devices
Three Ropes & Gray attorneys say it is likely that some aspects of the FDA final guidance on clinical decision support (CDS) software released in September will be controversial. Speaking on their firm’s Non-binding Guidance podcast, the attorneys note that the final guidance “represents a substantial change in
Drugs
FDA says it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with Amgen’s osteoporosis drug Prolia (denosumab). “Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of
FDA Policy/General
Federal Register notice: FDA is identifying two bulk drug substances that it has considered and proposes to include on its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on
FDA Policy/General
The FDA Modeling and Simulation (M&S) Working Group, created in 2016 by the agency’s Office of the Chief Scientist, has issued a report on how M&S is used across and within FDA Centers and the impact it has had on the agency’s mission to
Drugs
GSK says that at FDA’s request it is withdrawing the accelerated approval for Blenrep (belantamab mafodotin-blmf) due to the therapy’s poor showing in progression-free survival (PFS) in a Phase 3 confirmatory study. The monotherapy treatment was granted accelerated approval in 2020 for adult patients with relapsed
Drugs
FDA has approved Behring’s Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy to treat adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current of historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. An agency
Biologics
A 3/1-3/22 FDA inspection at Invitrx Therapeutics, Lake Forest, CA, found multiple violations in the firm’s manufacturing of cellular and acellular products for allogeneic use. An 11/9 Warning Letter says the products are intended to be administered by injection, ophthalmically, or by nebulization and purport
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The document describes FDA’s regulatory and enforcement priorities related to compounded beta-lactam oral antibiotic suspension products that appear on
Devices
FDA says it received more than 21,000 medical device reports (MDRs) from 8/1 to 10/31 associated with PE-PUR foam breakdown in Philips Respironic ventilators, BiPAP machines, and CPAP machines. There were 91 reports of deaths in the latest reports, the agency says. The FDA notice says
Drugs
FDA has announced a 1/26/2023 Webinar entitled FDA’s Labeling Resources for Human Prescription Drugs that will discuss new resources available for the pharmaceutical industry. The resources are listed on an agency-maintained Webpage and include: * Prescribing Information Resources, which includes a sample template for the prescribing information
Devices
FDA has updated a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user access to information about safety issues with the device. For example, the latest notice includes a recent letter from Medtronic that says two groups of the
FDA Policy/General
Federal Register notice: FDA is correcting a 9/28 notice entitled “Statement of Organization, Functions, and Delegations of Authority” that discussed a reorganization of its Office of Regulatory Affairs headquarters and field offices. The correction addresses editorial errors and depicts the proper organizational components within ORA. To view the notice,
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement. The device features a new porous version of the Persona anatomic tibia with Zimmer Biomet’s OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build
Drugs
FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday (MWF) intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). The therapy is approved for use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia and lymphoblastic lymphoma in adult
FDA Policy/General
Federal Register notice: FDA has announced a 12/8 meeting of the Science Board to the FDA Advisory Committee. Panel members are scheduled to consider research needs for evaluating potential adverse health effects in children associated with oral cadmium exposure. They will also hear about the agency’s cross-cutting
Biologics
FDA has extended by three months the review of a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. Omidubicel is described as a first-in-class, advanced NAM-enabled stem cell therapy candidate. The review extension is related
Devices
FDA says it has asked for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of its Trilogy ventilators that have been “reworked” as a part of a 6/2021 recall. The information request is intended to help FDA better understand the cause
Drugs
FDA has approved a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes in adults and pediatric patients eight years of age and older who currently have Stage 2 Type 1 diabetes. “The drug’s potential to delay clinical
Drugs
FDA inspections of drug manufacturing operations are going to be geared to increased scrutiny of management’s responsibility and risk management operations, according to FDA Office of Regulatory Affairs (ORA) Division of Pharmaceutical Quality Operations III program director Jeffrey Meng. He provided an ORA compliance update during an online PharmaLink
Drugs
Pfizer and BioNTech have announced results showing that their current authorized bivalent booster vaccine provides a greater increase in neutralizing antibody titers than their original Covid-19 vaccine against emerging Omicron sublineages. “Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved