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Orthopedics

Rilzabrutinib & First Biosimilar Golimumab Among New EU Filings

Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products for which marketing applications are currently under review. Both drugs are investigational and are yet to be approved anywhere in the world.

Gohibic For SARS-CoV-2-Induced ARDS Among Eight New Drugs To Win EMA Nod

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

EU Crunch Time For Kizfizo, Sipavibart, Coacillium And Eight Other Products

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

Janssen’s Nipocalimab Among Six New EU Filings

Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

With FDA Hold Lifted, Avidity Works To Bring First DM1 Therapy To Market

Avidity hopes to complete enrollment in mid-2025 for an ongoing Phase III trial of its antibody-oligonucleotide conjugate in myotonic dystrophy type 1, which has no approved drug therapy.

Medtronic Partners With Siemens Healthineers To Evolve AiBLE Spine Surgery Platform

The companies intend to co-market Siemens Healthineers’ Multitom Rax as part of Medtronic’s AiBLE ecosystem, which combines advanced technologies in navigation, robotics, imaging, data analytics, and AI to enhance the precision and predictability of spine and cranial surgeries.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Zimmer Biomet CPT Hip Tied To Fracture Risk

The US FDA is advising against use of the Zimmer Biomet CPT hip implant after research indicated it may pose a higher risk of thigh bone fracture than similar products.

Biocomposites Fully Acquires SYNICEM And Subiton Lines, Launches NanoBone In UK

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.