Ajovy bags NICE approval

UK – NICE launches consultation on its methods of drug evaluation

The health technology assessment (HTA) agency launched a public consultation last week on a proposal for changes to the methods it uses to evaluate...
”Blue – Box” requirements

Europe – Information on Nitrosamines for Marketing Authorisation Holders

The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders (see below)  to 1...

International – EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have established a...

International – Study finds mixed vaccine schedules provide strong immune response against COVID-19

The Com-Cov study was initially launched in February, becoming the first trial in the world to evaluate whether different vaccines can be used safely and effectively...

USA – FDA issues guidance on cell, gene therapy manufacturing

Manufacturers of cell and gene therapies have a new guidance from the US Food and Drug Administration (FDA) that provides pandemic-related manufacturing considerations. The guidance...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – NICE pushes social prescribing for dementia

The guidance suggests that those living with dementia should be offered activities such as “exercise, aromatherapy, art, gardening, baking, reminiscence therapy, music therapy, mindfulness...
NICE nod for Novartis’ Luxturna

UK – NICE nod for Novartis’ Luxturna

The treatment has been approved as an option for treating RPE65-mediated inherited retinal dystrophies in people with vision loss caused by inherited retinal dystrophy...
NICE ‘OK’ for Lynparza

UK – NICE recommends Elmiron for bladder pain syndrome

The company “welcomed” the decision, saying that the organisation has approved the medicine, usually used in BPS with glomerulations or Hunner’s lesions, is used...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs

The US Food and Drug Administration (FDA) on Thursday finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active...

Europe – ECDC and EMA highlight considerations for additional and booster doses of COVID-19...

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general...

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