Drugs
Lilly says its Retevmo (selpercatinib) met the primary endpoint of progression-free survival in the LIBRETTO-531 study evaluating the drug versus doctors’ choice of approved multikinase inhibitors cabozantinib (Exelixis’ Cabometyx) or vandetanib (Sanofi’s Caprelsa) as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)
Drugs
FDA has granted Nexcella an orphan drug designation for NXC-201 for treating multiple myeloma. The next-generation BCMA-targeted CAR-T cell therapy is currently being evaluated in the Phase 1b/2a clinical trial called NEXICART-1 (NCT04720313), the company says. To date, over 50 patients have been dosed,
Drugs
FDA says Amazon and Walmart are illegally distributing unapproved new drug products intended to treat molluscum contagiosum. The agency issued 8/18 Warning Letters to each company. The Walmart letter says the company’s Web site offers the Naturasil Molluscum Treatment Kit. FDA says it purchased the kit from the
Drugs
FDA has lifted a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease (SCD). The hold was ordered 2/23 based on preclinical data previously submitted in 4/2022, 10/2022 and 12/2022, Fulcrum says, adding that non-clinical and
Drugs
Metacel Pharmaceuticals is petitioning FDA to require all sponsors of generic forms of its Ozobax (baclofen) oral solution to conduct and provide the same amount of safety data as the agency asked Metacel to perform in support of the supplemental approval of Ozobax. The petition specifically asks FDA to: * require
Drugs
Rep. Jeff Duncan (R-SC) says FDA’s proposed Human Foods Program reorganization could adversely affect its regulation of dietary supplements. The agency has proposed creating an Office of Food Chemical Safety, Dietary Supplements, and Innovation, eliminating the current separate Office of Dietary Supplement Programs that now regulates the products.
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Huntington’s disease (HD). Previously, the drug was approved for treating adults with tardive dyskinesia. Approval was based on data from two clinical studies conducted in collaboration with the Huntington Study Group
Drugs
FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating magrolimab to treat acute myeloid leukemia (AML). The hold, which applies to new patients entering magrolimab studies, follows the company’s recent announcement that it is discontinuing the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic
Drugs
FDA has accepted for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). Geron says imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies
Drugs
The U.S. Justice Department 8/21 announced deferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA and Glenmark Pharmaceuticals. The agreements are part of a years-long probe into price fixing by several generic drug companies, according to the government. As part of the agreements, Teva admitted
Drugs
FDA is planning to finalize by 9/30 its draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which replaced a 2018 draft guidance on content of premarket submissions for management of cybersecurity in medical devices. If all goes as planned, the guidance will
Drugs
After resolving inspection concerns at its contract manufacturer (Catalent) that were raised in a 6/27 complete response letter (CRL), Regeneron Pharmaceuticals was granted FDA approval 8/18 for Eylea HD (aflibercept) injection 8 mg, a higher dose of the popular 2 mg treatment for patients with wet age-related
Drugs
While the U.S. continues to struggle with ongoing drug shortages, particularly cancer drugs, FDA commissioner Robert Califf will be heading soon to India to meet with Indian regulatory and drug industry officials, according to HHS secretary Xavier Becerra. Speaking to reporters 7/18 on the sidelines of the G20
Drugs
FDA has approved a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age and older with Chaple disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is described as a monoclonal antibody designed to target complement factor C5, a protein involved
Drugs
Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating adults with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor therapies. The oral hypoxia-inducible
Drugs
Medical device recall events fell 4.4% in the second quarter of 2023 from 252 in the first quarter to 241, according to the latest Sedgwick Recall Index. Meanwhile, the index says, drug recall events fell 6.3% from 144 in the first quarter to 135 in the second quarter.
Drugs
FDA has granted Nuvectis Pharma’s NXP800 an orphan drug designation for treating cholangiocarcinoma. The company describes NXP800 as an oral small molecule with a novel mechanism of action that has “demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as
Drugs
FDA has approved Ipsen’s NDA for Sohonos (palovarotene) capsules as a retinoid indicated to reduce in volume new heterotopic ossification in adults and pediatric patients aged 8 and older for females and 10 and older for males with fibrodysplasia ossificans progressiva (FOP). The company says it is the first
Drugs
Vanda Pharmaceuticals is pushing back on a proposed order drafted by CDER in which FDA commissioner Robert Califf would refuse to either grant summary judgment to the company and approve its sNDA for a new indication for Hetlioz (tasimelteon) to treat jet lag disorder or hold a hearing on the
Drugs
Attorney Douglas Farquhar (Hyman, Phelps & McNamara) says the current situation in which a larger than usual percentage of OAI (official action indicated) drug company inspections results in the exercise of FDA enforcement discretion may not continue. Writing in his firm’s FDA Law Blog, Farquhar reports on a presentation
Drugs
The FDA National Center for Toxicological Research says its PathologAI initiative is intended to develop an effective and accurate framework for the analysis of histopathological data from animal studies to advance digital pathology in preclinical application. An online post says PathologAI “may quickly and accurately identify and quantify specific lesion
Drugs
CDER researchers have identified several common deficiencies found in regulatory submissions involving the use of continuous manufacturing (CM) and/or real-time release testing for dissolution (RTRT-D). Writing in the Journal of Pharmaceutical Sciences, the researchers say their intent is to provide recommendations for best practices that will help