Orthopedics

While the European Medicines Agency’s human medicines committee voted in favor of EU approval for 10 new products, it reaffirmed its previous decision not to grant Aqneursa new active substance status.

Stryker’s Indian market growth will outpace the company’s average growth by a factor of three, company CEO Kevin Lobo told the APACMed medtech forum, before officially opening a new R&D center in Bangalore.

The European Medicines Agency is this week expected to recommend whether EU marketing approval should be granted to myriad new products, including therapies for bronchiectasis, RSV, menopause-related symptoms and type 2 diabetes.

After divesting bone healing products in mid-year, Highridge Medical doubled down on its spine capabilities with a triple purchase of technologies from Accelus, bringing access to “Adaptive Geometry.” CEO Rebecca Whitney explained Highridge’s strategy.

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.

A new study by AcuityMD, presented at AAOS 2025, highlights the continued shift of spinal surgeries to the outpatient setting, with state-by-state variability in ASC adoption. While hospitals still dominate spinal procedures, advancements in minimally invasive techniques and medical technologies are major drivers of spinal surgeries in the ASC setting.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

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.