Drugs
FDA has issued Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility last month in Telangana, India. According to the FDA-483, the agency cited the following: * The quality unit has not established adequate procedural controls
Drugs
AstraZeneca and Daiichi Sankyo say new data show that their antibody-drug conjugate Datroway (datopotamab deruxtecan) significantly improved survival outcomes for patients with metastatic triple-negative breast cancer who are not eligible for immunotherapy. Results from the Phase 3 TROPION-Breast02 trial also showed the therapy met its second co-
Drugs
Abivax is announcing new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements across all efficacy endpoints in patients with moderately to severely active ulcerative colitis — including those who had previously failed multiple advanced therapies. The results, presented at the United European Gastroenterology Meeting in
Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children ages 2 to 5, expanding access to the company’s once-daily, steroid-free topical therapy. “In clinical trials, Zoryve cream 0.05% rapidly improved eczema severity,
Drugs
FDA has unveiled a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutical manufacturing and testing. The initiative will give faster review timelines to generic drugmakers that conduct bioequivalence testing in the United States and manufacture products domestically using U.
Drugs
FDA commissioner Marty Makary says he wants to speed up the nation’s drug approval process without compromising safety, describing his plans to “modernize” the agency in a wide-ranging interview with CNN’s Sanjay Gupta. Speaking in Atlanta last week during a CEO listening tour, Makary told Gupta that
Drugs
A new Brookings Institution commentary is raising concerns about FDA’s new Commissioner’s National Priority Voucher (CNPV) pilot program, arguing that its core incentive of accelerated drug reviews may fall short of advancing broader public health goals like onshoring drug production and improving affordability. Launched in June, the CNPV
Drugs
FDA is facing mixed reactions after approving the second generic copy of the abortifacient drug mifepristone 10/2. The manufacturer, Evita Solutions, becomes the second company authorized to market a generic version of the drug, joining GenBioPro, whose generic version was approved in 2019. The approval comes at a time
Biologics
FDA has posted a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of India’s Maharashtra manufacturing facility 7/2024. The agency cited the firm over Covid-19 syringe-filling line deficiencies. It also said the company had insufficient data for a validation study related
Biologics
Rocket Pharmaceuticals has voluntarily withdrawn its BLA for RP-L102 (mozafancogene autotemcel), an investigational gene therapy for treating Fanconi Anemia. The move follows the company’s previously announced corporate prioritization to focus its resources on programs with the clearest regulatory and commercial pathways. The company notes its decision “does not
Drugs
Amgen says the landmark Phase 3 VESALIUS-CV trial met its primary endpoints, demonstrating that Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events in individuals without a prior history of heart attack or stroke. A company statement says the study involved over 12,000 high-risk patients.
Drugs
FDA has released a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firm’s drug manufacturing facility in Barcelona, Spain. For example, the agency cited the firm for failing to establish written procedures for production and process controls, and for
Biologics
FDA has accepted for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) use followed by paclitaxel, trastuzumab, and pertuzumab (THP) as a neoadjuvant treatment for patients with high-risk, early-stage HER2-positive breast cancer. The agency has set a user fee review action
Drugs
FDA has approved Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) in combination with atezolizumab (Genentech’s Tecentriq) or atezolizumab and hyaluronidase-tqjs (Genentech’s Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The approval covers patients whose disease has not progressed following initial treatment
Drugs
FDA commissioner Martin Makary says changes easing the Boxed Warning on hormone replacement therapies should be announced soon. “We are in serious discussion now about what to do about the black box warning, and I think you’ll hear something on it very soon,” Makary said on a CNN podcast.
Drugs
FDA has granted Bristol Myers Squibb fast-track status for its investigational Alzheimer’s therapy BMS-986446. The anti-microtubule binding region tau (anti-MTBR-tau) antibody is currently in Phase 2 testing for patients with early disease. The company says BMS-986446 is designed to target fragments of tau
Drugs
FDA has issued a report, “An Assessment in Support of the Sentinel System (2022 to 2024),” highlighting the Sentinel System’s activities and achievements in the study period. The report fulfills one of the commitments in the Prescription Drug User Fee Act VII reauthorization letter to maintain Sentinel initiative capabilities
Drugs
FDA and Vanda Pharmaceuticals have agreed to a framework for resolving their ongoing disputes about the company’s sleep-wake cycle drug Hetlioz (tasimelteon) and its gastroparesis drug tradipitant. A Vanda statement lists these features of the agreement: * FDA will conduct an expedited re-review of the partial clinical hold
Devices
A CDRH Learn education module presented by Postmarket Industry Education Team assistant director Tonya Wilbon covers the Quality Management System Regulation (QMSR) with its requirements for risk management, a risk-based approach, and risk-based decisions. The module defines essential risk terms; explains the role of risk management within the
Drugs
FDA has issued 17 new and 64 revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The PSGs contain: * 48 PSGs for products with no approved ANDAs, including 25 complex products; * 39 PSGs for complex products (six new and 33 revised
Drugs
FDA has granted Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory Large B-cell Lymphoma and Chronic Lymphocytic Leukemia following two or more prior therapies. The company describes UB-VV111 as an off-the-shelf, in vivo CAR T cell therapy
Drugs
FDA has issued a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their NDA for CUTX-101, a copper histidinate therapy for treating Menkes disease in pediatric patients. The letter cited manufacturing and GMP concerns at the facility producing CUTX-101, according to the