Novartis Lamisil TV Ad Cited For “Dominant,” “Distracting” Digger Character

FDA is objecting to the sequence in which Novartis presents the qualifying and efficacy information for its anti-fungal Lamisil in the company's TV ads

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.