Drugs
FDA has released a draft guidance entitled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).” The document provides sponsors with recommendations for conducting multiregional clinical trials (MRCTs) whose data are intended to support applications for oncologic drugs. The agency describes an MRCT as a trial that
FDA Policy/General
Federal Register notices: FDA has classified the following three devices into Class 2 (special controls) based on de novo classification requests: * Clozapine test systems — Saladax Biomedical de novo classification request for MyCare Psychiatry Clozapine Assay Kit. The device is intended to measure clozapine in human specimens, and the results are
FDA Policy/General
FDA has posted a CVM draft guidance entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.” The document replaces a 2015 version made available 9/2015 entitled “Two-Phased Chemistry, Manufacturing and Controls Technical Sections.” The revision provides recommendations for submitting individual components of the CMC technical section (e.
Drugs
FDA has cleared an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea. The device is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with
Drugs
Boehringer Ingelheim says it is submitting an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phase 3 FIBRONEER-IPF study met its primary endpoint, which was the absolute change from baseline in lung function measure forced vital capacity (FVC) at Week 52 versus placebo. The
Devices
Fresenius Kabi is recalling (Class 1) one lot of the Ivenix Large Volume Pump (LVP) primary administration sets after documenting a manufacturing defect that may cause uncontrolled medication flow. “The use of affected product may cause serious adverse health consequences, including medication overdose and death,” a recall notice says. To
Drugs
FDA has lifted a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib studies, including a Phase 1 (ZN-c3-001) dose-escalation study in solid tumors, a Phase 2 (DENALI) study in platinum-resistant ovarian cancer, and a Phase 2 (TETON) study in uterine serous carcinoma. The June action was in
Drugs
Medexus Pharmaceuticals says FDA has extended by three months the review of its Medac licensor’s resubmitted NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The agency notified Medac that it requires additional time to review supplemental analyses of
FDA Policy/General
Federal Register notice: FDA is announcing its support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions for CDER/CBER regulated products. The version of eCTD currently supported by the agency is specified in the FDA Data Standards Catalog (https://www.fda.gov/regulatory-information/
Drugs
FDA has approved a subcutaneous injectable formulation of Genentech’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all the adult indications as the product’s intravenous formulation, including non-small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Approval was based on
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 ANDAs. Two ANDAs were incorrectly listed and this notice corrects the errors. To view the notice, click here.
Drugs
FDA has granted expanded approval for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients (aged 12 to 17 years) with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This expands the initial 6/2019 FDA approval in CRSwNP for patients aged 18
Drugs
FDA has approved an Eli Lilly BLA for Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for treating adults and children 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well-controlled despite treatment with topical prescription therapies. The therapy works by targeting
Devices
FDA has cleared a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identifying cells, vessels and their architecture. The device is designed to provide real-time, high-resolution imaging of fresh tissue surfaces, offering surgeons and pathologists the information for excised tissue,
Drugs
FDA has approved Genentech’s Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relapsing multiple sclerosis and primary progressive multiple sclerosis. “Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in
Drugs
A group of bipartisan U.S. senators have introduced the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the FDA Modernization Act 2.0 (FDAMA 2.0), legislation passed by Congress in 2022 to modernize drug testing protocols and improve patient outcomes. The law
Drugs
FDA is seeking comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, original BLAs, and select efficacy supplements. An agency notice says the comments should focus on the characteristics of the Integrated Review and specifically address the following: 1.
Drugs
FDA has published a guidance, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, describing how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types listed in the Federal Food, Drug, and
Devices
FDA has authorized the first over-the-counter hearing and software device that is used with compatible versions of the Apple AirPods Pro headphones. An agency statement says that the authorized Apple Hearing Aid Feature (HAF) enables compatible versions of the AirPods Pro to operate as an over-the-counter
Biologics
FDA has approved Johnson & Johnson’s Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). Approval was based on data from the ongoing Phase 2b/3 QUASAR study evaluating Tremfya in adult patients with moderately to severely active UC who experienced an inadequate response or
Biologics
Gilead Sciences says data from an interim analysis from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, showed that it reduced HIV infections by 96% compared to background HIV incidence. “There were two incident cases among 2,180 participants, corresponding to
Biologics
GSK says it is moving its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data that demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults. “Interim data suggest the vaccine candidates have an acceptable safety