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3,031 changes Pharma & Drug Safety

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Merit Medical Recalls 16F Dual-Valved Splittable Sheath Introducer

Merit Medical is recalling the 16F Dual-Valved Splittable Sheath Introducer, a component used in several dialysis catheter kits, due to a design defect where the sheath introducer may not split as intended. The FDA has classified this as a Class I recall, the most serious type. Healthcare providers are advised to immediately stop using, apply recall stickers to, and destroy affected devices. Two serious injuries have been reported as of February 23, 2026, with no deaths associated with this issue.

Urgent Enforcement Medical Devices
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Anti-IgG Nanobodies Patent Granted to Max-Planck

USPTO granted patent US12600799B2 to Max-Planck-Gesellschaft on April 14, 2026 for novel anti-IgG nanobodies directed against rabbit or mouse IgG. The patent contains 11 claims classified under CPC C07K 16/42. The invention also covers methods for producing and using said nanobodies.

Routine Rule Intellectual Property
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Single-Domain Antibodies That Bind ROR1

USPTO granted Patent US12600801B2 to Fred Hutchinson Cancer Center for single-domain antibodies binding receptor tyrosine kinase ROR1. The patent covers anti-cancer therapeutics, antibody-drug conjugates, multi-domain binding molecules, and cancer imaging/diagnostic agents. The patent contains 20 claims with inventors Jason Price, Colin E. Correnti, and James M. Olson.

Routine Notice Intellectual Property
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CD38 Antibody Variant Improves Manufacturing Yield

USPTO granted patent US12600790B2 to Vivasor, Inc. covering a variant anti-CD38 IgG antibody with improved manufacturing yield and a mutated light chain that reduces cleavage heterogeneity. The patent contains 19 claims and is classified under C07K 16/2878 and related CPC codes.

Routine Rule Intellectual Property
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5T4 Binding Polypeptides for Cancer Therapy

USPTO granted patent US12600794B2 to Abdera Therapeutics for 5T4 binding polypeptides useful for cancer therapy. The 36 claims cover polypeptides conjugated to chelating agents or radionuclide complexes. The patent protects compositions and methods for treating 5T4-expressing cancers.

Routine Notice Intellectual Property
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IGF-1R Antibodies With Extended Half-Lives for Thyroid Eye Disease Treatment

USPTO granted US Patent US12600788B2 to Viridian Therapeutics, Inc. covering antibodies and compositions targeting Insulin-Like Growth Factor-1 Receptor (IGF-1R) with extended half-lives for treating thyroid eye disease. The patent contains 18 claims and names six inventors including Vahe Bedian, Peter Harwin, and Jonathan Violin.

Routine Rule Intellectual Property
1d ago FDA Press Releases
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Draft Guidance on Safety Assessment of Genome Editing Using Next-Generation Sequencing

The FDA's Center for Biologics Evaluation and Research issued draft guidance recommending next-generation sequencing methods for assessing off-target editing risks and genome integrity in human gene therapy products using genome editing technologies. The guidance applies to both ex vivo and in vivo products and provides recommendations on sequencing strategies, sample selection, analysis parameters, and reporting. Sponsors submitting investigational new drug applications or Biologics License Applications for genome editing therapies should incorporate these safety assessment methods into nonclinical studies. The FDA is accepting public comments for 90 days.

Priority review Consultation Pharmaceuticals
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Tumor-Targeted Bispecific CD28 Antigen Binding Molecules Patent Grant

USPTO granted patent US12600781B2 to Hoffmann-La Roche Inc. covering tumor-targeted bispecific agonistic CD28 antigen binding molecules characterized by monovalent binding to CD28. The patent includes 51 claims covering the binding molecules, methods of production, pharmaceutical compositions containing these antibodies, and methods of using the same for cancer treatment.

Routine Notice Intellectual Property
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Novo Nordisk Patent for IL-6 Antagonist Treatment of Diuretic Resistant Heart Failure

The USPTO granted Patent US12600773B2 to Novo Nordisk A/S on April 14, 2026, covering methods of treating diuretic resistant heart failure patients carrying at least one copy of the TMPRSS6 rs855791 allele by administering an IL-6 antagonist. The patent also covers treatment of patients with elevated urine or plasma IL-6 levels requiring diuresis. The patent (CPC: C07K 16/248) names five inventors and issues from Application No. 17519082 filed November 4, 2021, with 10 claims granted.

Routine Rule Intellectual Property
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LAG-3 Antibody Combination Therapies - Patent US12600777B2

The USPTO granted patent US12600777B2 to Novartis AG covering combination therapies comprising antibody molecules that specifically bind to LAG-3. The patent contains seven claims and relates to methods for treating, preventing, and/or diagnosing cancerous or infectious disorders. This represents a grant of exclusive intellectual property rights to Novartis AG for the therapeutic application of LAG-3 antibody combinations.

Routine Notice Intellectual Property

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