International – The most-used drugs for treating COVID-19

More than 18 months into the COVID-19 pandemic, there are still very few drugs authorized by the FDA to treat the virus. Just one drug, remdesivir,...

International – Interventions dans la prévention des troubles persistants de l’odorat (dysfonctionnement olfactif) suite...

Il a été constaté que la COVID-19 provoque des troubles de l’odorat. Il s'agit parfois d'une réduction de la capacité à sentir les choses,...
Danish Medicines Agency Ramps Up Capacity in Medical Devices

Denmark – Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19...

In the beginning of August, the Danish Medicines Agency received a report about a 17-year-old boy who after receiving the COVID-19 vaccine from Pfizer/BionTech...
3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

International – L’ICMRA cible les défis posés par l’IA dans le développement du médicament

PARIS (TICpharma) - Dans un rapport publié le 16 août, la Coalition internationale des autorités de réglementation des médicaments (ICMRA) a formulé plusieurs recommandations...

International – BioNTech says booster doses may be more effective than a modified COVID-19...

BioNTech presented data showing Comirnaty’s effectiveness against different variants of SARS-CoV-2, including the Delta strain. “Evidence points to robust vaccine effectiveness against circulating variants in the...

International – WHO to test three more potential COVID-19 treatments

Several such trials are ongoing, including the RECOVERY trial in the UK and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) in the US. The...

International – Researchers: France could teach the US lessons in biosimilar pricing

The US should look to the French healthcare system for lessons in reducing biosimilar pricing, according to a recent paper published in Health Affairs. James C....

International – ICMRA releases framework for aligning global track and trace systems

The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a broad set of recommendations outlining how regulators and industry can set up track...
WHO drafts guidance for pharma supply chain tracking

International – WHO revises guidance on GMPs for investigational products, R&D facilities

The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well...

International – Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response

The inhaled two-dose candidate is modified from CanSinoBIO’s injected COVID-19 jab Ad5-nCoV vaccine, which is already approved in China and other countries around the...

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