NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

UK – NHS world first rollout of cancer jab that cuts treatment time by...

Following the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), the NHS in England will be the first health system in...

Europe – COVID-19 vaccines safety update

The safety of authorised COVID-19 vaccines is continuously monitored, and updated information is regularly provided to the public. Safety updates outline the outcomes from assessments...
Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

USA – Dems urge free OTC birth control while GOP fights to ban mail-order...

US Democratic senators have signed a letter to the Biden administration to issue guidances that ensure Perrigo’s over-the-counter birth control pill Opill (norgestrel) is...

Europe – EMA confirms measures to minimise risk of serious side effects with Janus...

EMA’s human medicines committee (CHMP) has endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with...
WHO drafts guidance for pharma supply chain tracking

International – WHO releases key regulatory considerations on AI for health

The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe

A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19...

UK – NICE recommends Koselugo for the treatment of neurofibromatosis type 1

NF1 is a debilitating genetic condition, which affects one in 4,000 individuals worldwide. In 30 to 50% of people with NF, plexiform neurofibromas tumours...

France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves

Les AINS, tels que l’ibuprofène, le kétoprofène, sont parmi les médicaments les plus utilisés en automédication comme antalgiques (anti-douleurs) ou antipyrétiques (anti-fièvre) chez les...

USA – FDA publishes two guidances on collecting clinical outcomes data

The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The...

France – Bronchiolite : Moderna annonce des résultats positifs pour son vaccin

« Le Covid a été un formidable accélérateur pour démontrer la puissance de l’ARN messager, mais nous ne sommes pas qu’une biotech du Covid », confiait...