Drugs
FDA has removed a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human triggering receptor expressed on myeloid cells 2 (TREM2) agonist for treating common neurodegenerative diseases associated with microglial dysfunction, particularly Alzheimer’s disease. The decision to
Drugs
An FDA review of records supplied by Industria Farmaceutica Nova Argentia in Milan, Italy, a manufacturer of over-the-counter drugs, found violations of current good manufacturing practice (CGMP) regulations. A 9/9 Untitled Letter says specific violations were: * failure to have, for each batch of drug product, appropriate laboratory
Drugs
Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint (progression-free survival (PFS)).The trial data demonstrated
Drugs
FDA has published a guidance, Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, that is intended to support the conduct of randomized clinical trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. The
Drugs
FDA has released a 10-observation Form FDA-483 issued to SSM St. Clare Health Center a for GMP deficiencies documented during a February inspection at an outsourcing facility in Fenton, MO. For example, the agency says the firm failed to establish written procedures for production and process controls. Investigators
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FDA has released a draft guidance entitled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).”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
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
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
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
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
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
Drugs
FDA has added a Warning to labeling for Astellas’ menopausal hot flashes drug Veozah (fezolinetant) indicating it can cause rare but serious liver injury. A 9/12 drug safety communication says the agency made the labeling update after reviewing a postmarketing report of a patient with elevated liver blood test
Drugs
A new National Academies book, Regulatory Processes for Rare Disease Drugs in the United States and European Union: Flexibilities and Collaborative Opportunities, has recommendations based on the Academies’ study of processes for evaluating the safety and efficacy of drugs for rare diseases in the U.S. and the European Union.
Drugs
The newly launched CDER Quantitative Medicine (QM) Center of Excellence (CoE) provides the organizational framework to foster collaboration and cooperation in QM efforts across CDER and facilitate engagement with all stakeholders to advance therapeutic medical product development, inform regulatory decision-making, and promote public health, That’s the explanation provided
Drugs
FDA has published a guidance, ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA, explaining to applicants how the assessment goals established in the GDUFA 3 agreement apply to amendments to either ANDAs or prior approval supplements submitted to FDA under section 505(j) of the Federal Food, Drug,
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has cited AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for migraine drug Ubrelvy (ubrogepant). The ad, featuring tennis great Serena Williams, contains misleading information about the drug's efficacy, OPDP says. The TV commercial