Vers une plus grande coopération des pharmacopées mondiales

Europe – Le droit de la concurrence comme vecteur de l’accès à des médicaments...

Face aux inquiétudes exprimées par le Conseil et le Parlement européen quant aux pratiques de certains laboratoires  qui pourraient limiter l’accès des patients à...
Ajovy bags NICE approval

UK – Report finds NICE’s routine appraisals need reform

The findings show that routine availability of new medicines was "delayed or prevented entirely due to an inflexible, inappropriate assessment processes". According to the report,...
Antibiotiques : la consommation reste trop élevée en France

India – Indian regulators tweak drug trial rules

The latest set of clinical trial rules, likely to be notified in March, will fast-track proposal clearances for Indian companies rather than their multinational...
ANSM : Accès à l’innovation thérapeutique, l’ANSM pérennise ses circuits accélérés d’autorisation d’essais cliniques de médicaments dits "fast-track"

France – Clinical trials on medicinal products submitted to the ANSM as part of...

Making health innovation accessible faster for patients is a priority that the government has posted in the CSIS 2018 (Strategic Council of Health Industries)...
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery

USA – Regenerative Medicines: FDA Finalizes Guidance on Expedited Programs

With almost 80 regenerative medicine advanced therapy (RMAT) designation requests in 2017 and 2018, it’s clear that the US Food and Drug Administration’s (FDA)...
Widening the availability of naloxone

UK – Widening the availability of naloxone

Regulations introduced in 2015 and amended in 2019 widened the availability of naloxone, a medicine which reverses the effects of a heroin (or other...
EMA suspends fenspiride medicines due to heart rhythm risks

Europe – EMA suspends fenspiride medicines due to heart rhythm risks

The decision is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) that showed that fenspiride has the potential to increase...
Alunbrig recommended by NICE for non-small-cell lung cancer

UK – Alunbrig recommended by NICE for non-small-cell lung cancer

The decision comes after an earlier appraisal consultation document (ACD) said the Takeda drug was not cost-effective in this setting. An improved commercial agreement from...
FDA approves first PI3K inhibitor for breast cancer

UK – NICE changes its mind on Perjeta

The recommendation is for treating early HER2-positive breast cancer in people who have had surgery, and whose cancer has already spread to their lymph...
Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

USA – Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting...

The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new...

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