Drugs
FDA has withdrawn its approval of TG Therapeutics’ Ukoniq (umbralisib), indicated to treat two specific types of lymphoma, for safety reasons. An agency drug safety communication says updated findings from the UNITY-CLL clinical trial continue to show a possible increased risk of death in patients receiving Ukoniq. “As a
Drugs
FDA has launched a Web page on FDA-recognized susceptibility test interpretive criteria (STIC). The page includes information on both antibacterial and antifungal susceptibility test interpretive criteria. According to the page, the 21st Century Cures Act requires FDA to post online information about the agency’s recognition or withdrawal from
Drugs
FDA has granted breakthrough therapy designation to Sanofi’s efanesoctocog alfa to treat people with hemophilia A. A company statement says efanesoctocog alfa is the first factor VIII therapy to receive the designation. Sanofi says the designation was based on the XTEND-1 Phase 3 study that demonstrated a clinically
Drugs
University and Veterans Affairs researchers say their study of Centers for Medicare and Medicaid Services (CMS) spending for drugs that received FDA accelerated approval often found that the approval was not associated with added value relative to existing therapeutic options. The study was published in JAMA Health Forum. The researchers
Drugs
FDA has lifted a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for treating adults with relapsed or refractory T-cell lymphoma. The hold was placed in February after one
Devices
FDA has cleared a Stryker 510(k) for its Q Guidance System, which is intended to be used with the company’s spine guidance software, for advanced planning and intraoperative guidance during open or percutaneous computer-assisted surgery. The company says the software is the first to receive clearance for
Devices
FDA has granted in part and denied in part four Consumers for Dental Choice petitions submitted from 2015 to 2017 asking for additional warnings and labeling requirements for amalgam use in dentistry. The denial letter says two of the petitions asked FDA to warn against dental amalgam use in children,
Drugs
FDA has approved two drug combinations for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma. Approval was given to Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy and Opdivo in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab)
Drugs
FDA has placed a clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said the hold is related to issues surrounding the trial’s protocol design, according to the company. Sanofi’s
Drugs
BioMarin Pharmaceutical says it plans to resubmit a BLA for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, by the end of September that will include previously reported results from the two-year follow-up safety and efficacy data from the Phase 3 GENEr8-1 study. In 8/2020,
Drugs
FDA has extended by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The revised user fee review action target date is 12/28. The review extension is intended to give the agency additional time to review
FDA Policy/General
Federal Register notice: FDA has announced a 6/30 Cellular, Tissue, and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss the current regulatory expectations for xenotransplantation products, including human cells that have had ex vivo contact with animal cells, and animal organs and cells for transplantation into
FDA Policy/General
Federal Register notice: FDA has announced a 6/7 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss an Emergency Use Authorization request by Novavax for its Covid-19 vaccine and its use in individuals 18 years of age and older. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced a 6/14-15 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss requests to amend the Emergency Use Authorization (EUA) of the Moderna Covid-19 mRNA vaccine to include the administration of a primary series to infants, children,
Biologics
A 12/6/21-2/4/22 FDA inspection at OsteoLife Biomedical, Miami, FL, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 3/31 Warning Letter says specific items of concern were: * failing to process HCT/Ps
Devices
CDRH says that as of 6/1 it plans to again accept all non-Covid in vitro diagnostic (IVD) pre-submissions. In an FDA Voices online post, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say that due to the continued elevated workload related
Devices
Researchers from several Harvard University schools and departments and in other international institutions are suggesting the need for an amalgam of centralized and decentralized regulation of clinical artificial intelligence (AI). The researchers discuss the benefits and challenges of such an approach in a report in the open-source journal PLOS
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of TG Therapeutics’ NDA for Ukoniq (umbralisib tosylate) tablets based on a company request. The drug gained accelerated approval 2/2021 for treating certain adult patients with relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. Earlier this year, FDA
FDA Policy/General
Federal Register notice: FDA has announced a 6/28 Vaccines and Related Biological Products Advisory Committee meeting. The panel is scheduled to discuss whether and how the SARS–CoV–2 strain composition of Covid-19 vaccines should be modified. To view the notice, click here.
Devices
FDA has cleared Abbott’s next-generation FreeStyle Libre 3 system for use by persons age 4 and older living with diabetes. The company says it is the most accurate 14-day continuous glucose monitor, with readings sent directly to a smartphone every minute. The company says the Libre 3
FDA Policy/General
Guide on Prostate Cancer Drug Development 05/27/2022 Federal Register notice: FDA is making available a final guidance entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.” The document describes FDA’s current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone analogs
FDA Policy/General
Shionogi reported positive results from two Phase 3 studies (COMPOSE I and II) demonstrating consistent efficacy and safety of naldemedine in treating opioid-induced constipation in patients with chronic non-cancer pain. The company says data are being presented today during the American Gastroenterological Association Presidential Plenary Session at the