Drugs
FDA has granted Allogene Therapeutics a fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients with advanced or metastatic clear cell renal cell carcinoma (RCC) in those who’ve failed standard RCC therapies. “ALLO-316 targets CD70, which is highly expressed in RCC with limited
Devices
FDA has issued a warning against using ACON Biotech Covid-19 tests. The agency says the China-made tests are labeled “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” and packaged in a dark blue box. This test has not been authorized, cleared, or approved for distribution or use
Devices
FDA has issued a rare Section 518(a) notification order to Philips Respironics “requiring the company to notify patients and others of the company’s 6/14/2021 recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk
Drugs
FDA has lifted an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19. The hold was placed in early January, when the agency requested further information on the preparation and administration of IMM-BCP-01 at clinical sites. IMM-BCP-01 is a three-antibody
FDA Policy/General
A Parkland, FL man who was the sales director for Blackstone Labs was sentenced 3/11 to 51 months in prison for conspiring to defraud FDA and conspiring to distribute anabolic steroids. According to a Justice Department release, a jury convicted James Boccuzzi in December for his and the firm’
Drugs
Venatorx Pharmaceuticals says it is planning an NDA submission in the fourth quarter after reporting “positive results” from its pivotal Phase 3 study evaluating cefepime-taniborbactam as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The company says that if approved the combination
Drugs
FDA has set 8/4 as the PDUFA target action date for an Acadia Pharmaceuticals resubmitted sNDA for a new indication for its Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The company says it was told by the CDER Division of Psychiatry that it
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