Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

The 50 million Europeans with peripheral artery disease have a new treatment option thanks to help restore blood flow to vessels below the knee now that Abbott Laboratories' Esprit BTK everolimus-eluting resorbable scaffold system has received CE mark. The stent, made of a material similar to dissolvable sutures, dissolves within three years.

The U.S. Patent and Trademark Office has reacted to the Federal Circuit’s decision in Shockwave v. CLSI with a policy memo that draws tighter lines around the use of applicant admitted prior art in attempts to invalidate a patent during inter partes reviews.

The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.

South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.

A few years after it was founded with the aim of taking RNA therapies to the next level, Arnatar Therapeutics Inc. emerged from stealth, disclosing a $52 million series A round raised in 2024 as well as U.S. FDA orphan and rare pediatric disease designations for ART-4, an antisense oligonucleotide candidate targeting the root cause of Alagille syndrome.

Arnatar Therapeutics Inc.’s ART-4, an upregulating antisense oligonucleotide (ASO) therapeutic candidate for the treatment of Alagille syndrome (ALGS), has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA. Approximately 95% of ALGS cases are caused by haploinsufficient mutations in the Jagged-1 (JAG1) gene, leading to insufficient JAG1 protein levels and impaired liver bile duct development.

Curasight A/S has received clinical trial approval from the EMA for phase I evaluation of Utreat as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. The trial will enroll participants with newly diagnosed verified or suspected glioblastoma, and dosing is expected to commence in the fourth quarter of this year.

The U.S. FDA has announced a class I recall for the Wallstent Monorail system by Boston Scientific Corp. of Marlborough, Mass, a device for treatment of carotid artery stenosis. The company advised customers in early July to return any unused inventory because the inner diameter of the stent is narrower than intended, which may lead to difficulties in extracting the delivery device after placement of the stent.