The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
The FDA has approved Astrazeneca plc and Amgen Inc.’s first-in-class biologic, tezepelumab, for the add-on maintenance treatment of adults and children ages 12 and older with severe asthma, adding further competition to a hotly contested market. An injection marketed under the brand name Tezspire, tezepelumab inhibits the action of thymic stromal lymphopoietin (anti-TLSP). This is a signaling molecule at the top of several cascades influencing allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call.
Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology.
TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada.
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Firstkind, Implicity, Roche, Sky Medical Technology.
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