Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Biogen, BMS, Gilead, Gracell, Moderna, Pfizer, Roche.
The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot.
Biomarin Pharmaceutical Inc.’s data supporting the use of Voxzogo (vosoritide) in children with the most common form of dwarfism proved compelling for the FDA, which cleared the modified C-type natriuretic peptide as the first treatment for the rare genetic disease affecting bone growth.
Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads.
LONDON – The first commercial implantations of Istar Medical SA’s minimally invasive Miniject supraciliary glaucoma drainage device have taken place in Germany, following European CE approval for the product.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armata, Heron, Longeveron, Mediwound, Merck, Molecular Templates, Verrica, Vitro.
The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices granted market access under the legacy system. MDCG has clarified that these devices will be subject to postmarket surveillance requirements under the MDR system rather than the previous system, although it is not a simple process to determine when this approach does and does not apply.
Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.
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