Drugs
FDA has accepted for review an Autolus Therapeutics BLA for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. A company statement says FDA has set a PDUFA target action date of 11/16. The submission is based on data from the
Drugs
After evaluating an identified risk of T-cell malignancy following BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, FDA has ordered safety labeling changes for five of the products. The agency had announced on 11/28/2023 that it had received reports of T-
Drugs
The United States Court of Federal Claims has denied in part and granted in part an FDA motion to dismiss a Vanda complaint against the agency for lack of subject matter jurisdiction and failure to state a claim upon which relief can be granted. The decision says the case involves
Drugs
Two Generation Patient executives and a Dartmouth Institute for Health Policy and Clinical Practice professor say FDA and the Federal Trade Commission (FTC) need to develop and clarify regulations to protect patients from potential harm and misleading information on social media platforms, particularly from influencers. Writing in a StatNews post,
Devices
FDA has published a draft guidance, Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices, with recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. The document says the recommendations reflect current review practices and are intended
Drugs
FDA has approved a Vanda Pharmaceuticals IND to evaluate VCA-894A for treating patients with Charcot-Marie-Tooth disease, axonal, Type 2S (CMT2S), caused by cryptic splice site variants within the immunoglobulin mu-binding protein 2 (IGHMBP2) gene. CMT2S is a rare, inherited peripheral neuropathy for which there is no
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has faulted a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) for false or misleading efficacy representations. “This violation is particularly concerning because the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic
Drugs
FDA has cleared a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients. Customized for each patient, the device directs radiation to the target tumor area while reducing harmful impact to surrounding tissue, according to the company. “A
Drugs
FDA has lifted a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of hereditary angioedema (HAE) attacks. The agency action follows its review of data from a 26-week rodent toxicology study, the company says. The original hold has placed 8/2022. In
Devices
FDA has released a draft guidance entitled “Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.” The document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings or calcium phosphate coatings on the surface. They are intended to reflect current review practices and are
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients with a food allergy. The submission is based on the “positive” data from the
Devices
FDA has granted Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density). The wearable belt is worn on the hips and delivers calibrated vibration to the lumbar spine and hips, the
Drugs
Gilead Sciences says its Trodelvy (sacituzumab govitecan-hziy) Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated patients with metastatic non-small cell lung cancer (NSCLC). The therapy is currently FDA approved for treating certain patients with breast cancer. EVOKE-01
Devices
FDA has cleared a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients. Customized for each patient, the device directs radiation to the target tumor area while reducing harmful impact to surrounding tissue, according to the company. “A
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements — 21 CFR Part 203.” The collection supports agency regulations that set requirements for the: (1) reimportation and wholesale distribution of prescription drugs; (2) sale, purchase, or trade of, or
FDA Policy/General
Federal Register notice: FDA is announcing that a product was approved that redeemed a material threat medical countermeasure priority review voucher — Abbvie’s Qulipta (atogepant) tablets, indicated for preventing migraines in adults. To view the notice, click here.
Devices
Federal Register notice: FDA is announcing a 2/13 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel. Panel members are scheduled to discuss and vote on an Abbott PMA for its TriClip G4 System, indicated for improving health status in patients with symptomatic severe tricuspid regurgitation
Drugs
A 7/2023 inspection of Eli Lilly’s Branchburg, NJ cited eight GMP deficiencies, which included problems in overseeing manufacturing process and quality controls, equipment calibration, and maintaining facilities and equipment, according to inspection documents referenced in a Reuters report. The inspection was in response to a manufacturing change request
Devices
Globus Medical has recalled its ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error. An FDA notice says the recall is attributed to the device’s design. “A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate
Biologics
FDA is adding a Boxed Warning to Amgen’s osteoporosis drug Prolia (denosumab) about increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), especially those on dialysis. “Severe hypocalcemia appears to be more common in patients with CKD who also have a condition known as mineral
Drugs
Senator Amy Klobuchar (D-MN) has sent letters to six pharmaceutical companies — Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris, and Teva — requesting they remove all patents identified by the Federal Trade Commission (FTC) as improperly or inaccurately listed in FDA’s Orange Book by the end of the month. Klobuchar
Drugs
FDA has approved a Janssen Biotech NDA for Balversa (erdafitinib) for treating adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test. The drug is indicated for mUC patients whose disease has progressed on or after