Drugs
FDA says the Clinical Trials Transformation Initiative has published a report of its findings from a collaborative project with the agency to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. In the report, CTTI documented the
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FDA has revised its guidance entitled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” to update the lists of established sterilization methods. It also provides details about the pyrogenicity information that is recommended for sponsors to include in a 510(k)
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Alcon has announced “positive topline results” from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 for treating the signs and symptoms of dry eye disease (DED). “In both COMET-2 and COMET-3, which enrolled more than 930 dry
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FDA has granted Sellas Life Sciences a fast track designation for SLS009 (formerly GFH009), a highly selective CDK9 inhibitor for treating relapsed/refractory acute myeloid leukemia (AML). The designation is based on topline Phase 2a data that showed SLS009 in combination with venetoclax and azacitidine have “anti-leukemic effects with
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FDA has launched a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources and online content. The new search Web page queries existing guidance documents, manuals of policies and procedures, and compliance programs to provide users with up-to-date resources
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FDA issued a 1/4 complete response letter on the Astellas Pharma BLA for zolbetuximab, an investigational treatment for patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. A company statement
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CBER director Peter Marks says the benefits of chimeric antigen receptor T-cell (CAR-T) therapy far outweigh the risks involved, including secondary T-cell malignancies. Speaking 1/8 to the Alliance for Regenerative Medicine State of the Industry briefing, Marks said that while FDA issued a safety advisory for
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A 7/31-8/4/2023 FDA inspection at the Prime Lab drug manufacturing facility in Ponce, Puerto Rico, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. A 1/2 Warning Letter says the specific violations were: * failing to test samples of each component for
Drugs
Englewood, CO-based Leiters Health has recalled 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency. A recall notice says the affected products may contain twice the labeled amount of drug. “The semi-automated IV bag filling equipment used to
Drugs
CDER “first-cycle” drug approvals in 2023 shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-released report entitled Advancing Health Through Innovation: New Drug Therapy Approvals 2023. “This high percentage is in part reflective of the extent to
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FDA has granted Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy for treating patients with dermatomyositis to improve disease activity and for treating patients with systemic sclerosis (SSc) to improve associated organ dysfunction. “CABA-201 is designed to deeply
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Drugs
FDA has authorized Florida’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The drug importation program is authorized for two years from the date FDA is notified of the first shipment of drugs to be imported from Canada. FDA
Drugs
FDA has approved Novartis’ Radioligand Therapy (RLT) manufacturing facility in Indianapolis, IN, for producing prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which has been on the agency’s drug shortage list. The 70,000-square foot site is designed specifically for RLT manufacturing, and joins the company’s
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FDA has issued ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection of the firm’s Norwood, MA, facility documented GMP violations. For example, the FDA-483 says equipment utilized for drug substance manufacturing is not cleaned properly prior to its usage. “Specifically, your firm
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An FDA report on new safety signals seen in the FDA Adverse Event Reporting System between 7/2023 and 9/2023 includes reports of hair loss, aspiration, and suicidal ideation in some people using the popular GLP-1 receptor agonists like Novo Nordisk’s Ozempic (semaglutide), Wegovy (semaglutide), and Rybelsus
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FDA has lifted a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous and peripheral T-cell lymphoma. The hold was ordered 10/2023 following one fatal case of hemophagocytic lymphohistiocytosis (see story). The company now says the
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FDA should consolidate its recent draft guidance on “Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring Facilities” with similar draft guidances due to an overlap in content and to minimize confusion. In comments submitted to FDA, Pharmaceutical Research and Manufacturers of America (PhRMA) says the RIE guidance should
Drugs
The International Council for Harmonization (ICH) says the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted 12/14/2023 the ICH Q5A(R2) Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin to take effect 6/14. An
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An Eagle Hill consultants’ report says FDA has significant opportunities to benefit from further adoption of computer cloud technology if the agency can overcome obstacles identified in the report. The report was produced as part of an agency commitment in PDUFA 7 to “leverage cloud technology to progress regulatory digital
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The FDA Oncology Center of Excellence (OCE) is taking steps to encourage simplification of cancer clinical trials. Writing in a Comment in Lancet Oncology, researchers with the CDER Office of Oncologic Diseases and OCE say they want “the oncology drug development community to work to find opportunities to bring simplicity
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A retrospective study conducted by researchers from the FDA Oncology Center of Excellence and the National Institutes of Health found that overall, the representation of participants of racial and ethnic minority groups in studies supporting pediatric exclusivity requests appears to be comparable to the racial distribution of childhood cancers in