France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de...
La HAS confirme sa recommandation d’administrer une dose additionnelle de vaccin contre la Covid-19 aux personnes à risque de faire une forme sévère de...
UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision...
USA – FDA finalizes multiple endpoints guidance
The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
UK – European Commission Decision Reliance Procedure (EC DRP) extension
European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people...
USA – FDA allows sponsors to spread out costs in revised IND charging guidance
The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9...
EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and...
UK – Novo Nordisk’s weight-loss drug recommended by NICE
Patients will inject themselves once a week with pens pre-filled with semaglutide, also know as Wegovy. The drug will be offered alongside a reduced...
UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
PARIS (TICpharma) - Le gouvernement envisage une pénalité financière trimestrielle et reconductible de 2.000€ pour les pharmaciens d'officine qui contreviennent à leurs obligations en...
