Intracranial Hemorrhage Detection Software Receives FDA Clearance

UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata

NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency...

Europe – EMA proposes new guideline on non-inferiority trials

The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll

Pour l'industrie suisse des technologies médicales, la sécurité juridique est primordiale dans les relations avec l’UE. Swiss Medtech soutient donc le Conseil fédéral dans...

Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...

Europe – Evaluation of medicinal products indicated for treatment of bacterial infections

This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev...
NICE ‘OK’ for Lynparza

UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN

Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure. Patients...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024

EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when used...

Europe – Progress update on pilot for academic and non-profit developers of advanced therapy...

The aim is to guide non-commercial developers of promising ATMPs addressing unmet medical needs through the regulatory and scientific requirements in the European Union...

UK – Brainomix’s AI-enabled stroke software endorsed by NICE

The National Institute of Health and Care Excellence (NICE) has issued guidance endorsing the use of Brainomix’s artificial intelligence (AI)-enabled software, Brainomix 360, to...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Illegal medicines worth more than £30 million seized in the UK in...

This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical...

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