International – Convergence: Regulatory considerations in advancing gene and cellular therapies

When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate...

International – Vaccin contre le Covid-19 : bientôt un spray nasal pour stopper le...

Démodé la piqûre dans le bras, vous recevrez peut-être demain un vaccin dans le nez. La technologie déjà utilisée aux États-Unis contre la grippe...
Pharmaceutical industry groups and Canadian pharmacists staunchly opposed the US plan to allow states and drug companies to import certain

International – Drugmakers should question suppliers’ nitrosamine tests

The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products....

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....

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