Search

Arixtra Recall: Needle Iron Particle Discoloration in Pre-filled Syringes

BfArM issued a Drug Safety Communication regarding Viatris Healthcare Limited's Arixtra (fondaparinux sodium) pre-filled syringes. Reports indicate brown discoloration and blockage in needles caused by oxidized iron particles. Affected batches must not be dispensed or administered if discoloration is observed.

Mysimba Cardiovascular Risk and Annual Assessment Requirements

BfArM, in agreement with EMA, issued a Direct Healthcare Professional Communication regarding Mysimba (naltrexone/bupropion). The communication addresses long-term cardiovascular risks that have not been fully determined for patients treated beyond one year. New recommendations include discontinuation of treatment after one year if patients have not maintained at least 5% weight loss, and mandatory annual cardiovascular risk assessments for treatment continuation decisions.

Accupaque Visipaque Batch Risk Alert: Particle Contamination in Iohexol Iodixanol Solutions

GE Healthcare Buchler GmbH & Co. KG issued a Direct Healthcare Professional Communication (DHPC) alerting to a potential risk of particles in certain batches of Accupaque (iohexol) and Visipaque (iodixanol) solutions for injection filled into polypropylene bottles. The company instructs that only clear, particle-free solutions may be used per the Summary of Product Characteristics (SmPC), and this must be verified prior to administration.

Phenhydan Injection: DHPC on Visual Particles, Filter Required

BfArM published an updated DHPC from Desitin Arzneimittel GmbH regarding Phenhydan solution for injection (phenytoin sodium), following particle contamination identified in batch 021950 during official sample analysis. The company clarified that a syringe filter with 0.2-0.45 µm pore size must be used when drawing up the solution, then removed before patient administration. This supersedes the November 2025 filter guidance which was corrected for accuracy.

Eberth Antibiotics - Outdated Package Inserts Create Patient Safety Risk

Dr. Friedrich Eberth Arzneimittel GmbH issued a Direct Healthcare Professional Communication (DHPC) via BfArM alerting that certain batches of nine antibiotic and antifungal products have outdated package inserts, creating a potential patient safety risk. Affected products include multiple strengths of cefazolin, cefotaxime, ceftazidime, ceftriaxone, levofloxacin, moxifloxacin, and voriconazole. Healthcare professionals are advised to discard outdated package inserts and refer to the current package inserts provided with the communication.

ACTIVIN RECEPTOR TYPE II CHIMERAS AND METHODS OF USE THEREOF

The USPTO published patent application US20260098078A1 covering activin receptor type II chimera polypeptides for treating conditions involving muscle weakness and atrophy, bone damage, blood disorders such as anemia, thrombocytopenia, and neutropenia, as well as fibrosis, metabolic disorders, and pulmonary hypertension. The application describes extracellular ActRII chimeras optionally fused to Fc domains as therapeutic agents.

HIV/HBV Treatment Using CD8-Targeting Fusion Proteins

USPTO published patent application US20260098090A1 on April 9, 2026, disclosing fusion proteins for treating chronic viral infections including HIV and HBV. The application describes methods using CD8-targeting fusion proteins comprising antibodies specific to CD8b or CD8ab antigens combined with cytokines, chemokines, or growth factors. Inventors are Kelly Dare Moynihan, Yik Andy Yeung, and Ivana Djuretic, with filing date September 28, 2023.

Cμ4 Region for Multi-Specific Antibody Chain Pairing

USPTO published patent application US20260098094A1 assigned to DNA Twopointo, Inc. covering multi-specific antibodies with IgM Cμ4 region pairing domains for correct heavy and light chain pairing. The invention promotes correct chain combinations and disfavors incorrect pairings in bispecific antibodies. The application was filed November 21, 2025.

Protein Crystallization Method, Multiple Protein Feeds

Protein Crystallization Method, Multiple Protein Feeds

High-Purity Recombinant Human Albumin Preparation Method

Tonghua Anrate Biopharmaceutical Co., Ltd. has filed USPTO Patent Application US20260098079A1 for a method of preparing high-purity recombinant human albumin using medium-long-chain fatty acid ligands and ion exchange chromatography. The application discloses a process where oleic acid, myristic acid, sodium palmitate, and sodium stearate are combined with recombinant human albumin in defined molar ratios with poloxamer to achieve high stability and purity through sequential anion and/or cation chromatography to remove truncated and modified albumins.