Pharma & Drug Safety

Emend 125mg Shortage, Alternative Treatments Proposed

ANSM published guidance on April 15, 2026 regarding the shortage of Emend 125mg (aprepitant) oral suspension manufactured by MSD. The drug, used in chemotherapy for children and infants aged 6 months to under 12 years, became unavailable at the end of March 2026 due to production problems. ANSM has arranged alternative supplies including Ivemend 150mg imports and authorized pharmacists to dispense magistral preparations without new prescriptions.

Mektovi (Binimetinib) 15mg and 45mg Dosage Confusion Safety Alert

ANSM issued a drug safety alert regarding Mektovi (binimetinib), an anticancer medication, following 7 reported medication errors from confusion between the 15mg and 45mg tablet dosages. The errors, which began after the 45mg dosage became available in July 2025, resulted in overdoses causing hepatocyte cytolysis, intense fatigue, nausea, serous retinal detachment, and elevated lipase levels. The recommended dose is 90mg/day (either 3 tablets of 15mg or 1 tablet of 45mg twice daily).

Aerys Medical Bed Half-Rails Safety Recall by Winncare France

ANSM has published a safety alert regarding a field safety corrective action (FSCA No. R2610462) conducted by Winncare France for Aerys and Aerys Confort sliding medical bed half-rails. Users of the affected products have received direct correspondence from Winncare France. The alert is directed to pharmacies, community care facilities, retail establishments, and home health service providers.

Roche Oligonucleotides for Paternal UBE3A Expression

The European Patent Office published patent application EP3798307A1 for F. Hoffmann-La Roche AG covering oligonucleotides designed to induce paternal UBE3A expression. The invention relates to nucleic acid therapeutics targeting UBE3A gene expression, with applications in treating genetic disorders. The patent application was filed under IPC classification C12N 15/113 and designates all 39 contracting states across the European Patent Convention.

Percussionaire Corp Issues Phasitron 5 In-Line Valve Correction, Updates Use Instructions

Percussionaire Corporation issued an Urgent Medical Device Correction for the Phasitron 5 In-Line Valve (P5-TEE) due to a design limitation where leaks can occur through the pressure relief valve even when fully closed. The FDA classified this as a Class I recall, the most serious type. Leakage poses a high risk of cardiopulmonary and neurological compromise in neonatal and infant patients due to unrecognized hypoventilation, potentially causing respiratory acidosis, hypoxemia, or respiratory failure. Four serious injuries have been reported as of September 3, 2025, with no deaths.

Decapeptide-12 Modulates Sirtuin Gene Expression In Epidermal Keratinocyte Progenitors

The European Patent Office published patent application EP3601316A1 for Escape Therapeutics, Inc., covering decapeptide-12 compositions for modulating sirtuin gene expression in epidermal keratinocyte progenitors. The patent has been published with designated states covering all major European jurisdictions including DE, FR, GB, IT, ES, NL, and 23 other EU/EEA countries.

Treatment of Fuchs' Endothelial Corneal Dystrophy - Patent EP3592365A1

The European Patent Office granted patent EP3592365A1 to the University of Texas System and University of Massachusetts Medical School on April 8, 2026, covering oligonucleotide compositions for treating Fuchs' Endothelial Corneal Dystrophy. The patent is designated for all European patent states including DE, FR, GB, IT, NL, ES, and 26 others.

Antisense Oligonucleic Acid Patent - Osaka University EP3587576A1

The European Patent Office granted patent EP3587576A1 to Osaka University covering antisense oligonucleic acid compositions. The patent names inventors Obika, Satoshi; Waki, Reiko; Inoue, Takao; Yoshida, Tokuyuki; Morihiro, Kunihiko; Kasahara, Yuya; and Mikami, Atsushi. The patent is classified under IPC codes C12N 15/113, A61K 31/7115, A61K 31/712, and A61P 43/00, indicating pharmaceutical and therapeutic applications. Protection extends to designated contracting states including Germany, France, the United Kingdom, and other EU member states.

Janssen Patent Reduces Cardiovascular Events in Type II Diabetes Patients

The European Patent Office granted Patent EP3638250A1 to Janssen Pharmaceutica NV for a method of reducing or preventing cardiovascular events in patients with Type II diabetes mellitus. The inventors are Norman R. Rosenthal and Douglas K. Ways. The patent covers pharmaceutical compositions using compounds classified under A61K 31/7042 for therapeutic applications targeting cardiovascular outcomes in diabetic patients.

Syncore Biotechnology Pancreatic Cancer Treatment Patent EP3565530A1

The European Patent Office has published patent application EP3565530A1 by Syncore Biotechnology Co., Ltd., covering compositions and methods for treating refractory or multidrug resistant pancreatic cancer. The application claims therapeutic combinations including chemotherapy agents (A61K 31/337, A61K 31/7068) in liposomal formulations (A61K 9/127). This publication applies to 38 designated European Contracting States and establishes the application as published prior art.