Biologics
A California federal judge has approved a $3.65 million settlement with 1,063 former clients of StemGenex, a La Jolla, CA, stem cell clinic, and its former chief medical officer. The clients’ class-action suit filed in 2016 alleged that they were misled by StemGenex advertising and promotional materials
Drugs
Sen. Charles Grassley (R-IA) has called on the Federal Trade Commission to find a way to overcome a 2/17 deadlocked vote on initiating a study into the business practices of pharmacy benefit managers (PBMs). In a 3/9 letter to FTC chair Lina Khan, Grassley says PBMs “operate
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and
Drugs
FDA has issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after inspecting the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10. Without disclosing the cited observations, the company says it is confident they will be addressed and corrected to
FDA Policy/General
Federal Register notice: FDA has announced a 4/21-22 Oncologic Drugs Advisory Committee meeting. On 4/21, the panel will discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development for use in patients with hematologic malignancies and whether randomized data should be required to support a
Drugs
FDA has released the FDA-483 issued following an 11/8-12/2/21 inspection at Valgene Incorporated, doing business as Cape Drugs, an Annapolis, MD, producer of sterile and non-sterile drug products. The four inspection observations were: * disinfectant contact time (dwell time) and coverage of the item being
Drugs
AbbVie says that based on the results of the Phase 3 PROGRESS trial it will submit an sNDA to FDA to expand the indication for its Qulipta (atogepant) for the preventive treatment of chronic migraine. The company says Qulipta met its primary endpoint of statistically significant reduction from baseline in
Drugs
Two Morrison Foerster attorneys say the 2/10 meeting of the Oncologic Drugs Advisory Committee (ODAC) to consider a sintilimab application based on the ORIENT-11 trial conducted only in China sends a message to sponsors to engage early and formally with FDA if they want its approval for their
Drugs
The House Energy and Commerce Committee Health Subcommittee has announced a 3/17 hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.” The hearing will discuss various draft legislative proposals to revamp FDA’s approval and oversight of medical products, among other issues. For example, the
Devices
FDA has cleared a NeuroLogica (a subsidiary of Samsung Electronics) 510(k) for the addition of Photon Counting Detector (PCD) technology to its OmniTom Elite 16-slice computed tomography (CT) scanner. OmniTom Elite with PCD can generate spectral CT images at multiple energy levels, the company says. “Photon counting is
Drugs
FDA has published a draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, to provide clarity about existing requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain. The document describes the agency’s
Drugs
FDA has released a 26-page FDA-483 with 12 observations from a 9/21-11/4/21 inspection at SterRx, a Plattsburgh, NY, 503B outsourcing facility. The inspection observations were: * aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under pressure;
Drugs
FDA says that as a precautionary measure, specified lots of immune globulin intravenous and immune globulin subcutaneous have been voluntarily withdrawn by several manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. An agency online notice includes a list of the
Drugs
A Trinity Life Sciences online white paper says that while most of its recommendations for increasing the diversity of participants in clinical trials involve patients and drug companies, “diversity in clinical trials cannot be accomplished without coordinated efforts of clinical trial sites and overseeing regulatory bodies or sponsors.” The paper
Devices
Medtronic has recalled its TurboHawk Plus Directional Atherectomy System, which comprises a catheter and a cutter driver, because it is similarly designed as the company’s HawkOne Directional Atherectomy System, which was recently recalled for a correction. The device is used during procedures intended to remove a blockage from peripheral
Drugs
FDA is stepping up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs Advisory Committee meeting to review the issue. Recent concerns stem from a safety alert last month on a possible increased risk of death with TG Therapeutics’ PI3K inhibitor
FDA Policy/General
Federal Register notice: FDA has created a docket to receive comments on changes to the agency’s previously proposed quality metrics reporting program. The agency is considering revamping the program based on lessons learned from two 2018-announced pilot programs with industry, a site visit program, and stakeholder feedback on
Devices
The Regulatory Affairs Professional Society (RAPS) says FDA and the medical device industry have reached an agreement on the MDUFA 5 user fee program that will bring the agency $1.784 billion in user fees over the next five years. The total reportedly could grow to $1.9 billion if
Devices
FDA has cleared a Cionic 510(k) for its lightweight leg-worn Cionic Neural Sleeve, intended for functional electrical stimulation to assist in gait for people with foot drop and leg muscle weakness. It is designed to help people with mobility issues due to multiple sclerosis, stroke, cerebral palsy, and
Devices
Former FDAer Ryan Foringer has joined Hogan Lovell’s medical device and technology practice as a senior regulatory specialist. In his four years at the agency, Foringer was a consumer safety officer in the Center for Food Safety and Applied Nutrition, a lead reviewer and chemical engineer in the CDRH
FDA Policy/General
FDA would see a $102 million (3.2%) boost to its discretionary funding from Congress under a House and Senate Appropriations omnibus bill introduced 3/9 that covers 12 FY 2022 spending bills. Currently, FDA has been operating under a continuing resolution that has kept its spending level at FY
Drugs
Sanofi and partner Swedish Orphan Biovitrum (Sobi) have announced what they call positive topline results from the pivotal XTEND-1 Phase 3 study evaluating efanesoctocog alfa (BIVV001) in previously treated patients 12 years of age and older with severe hemophilia A. The companies say the data will support regulatory submissions