UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.
The decision follows the Medicines and...
USA – Dual draft guidances outline FDA vision for pediatric drug development, exclusivity
In a move that could ruffle the feathers of pharmaceutical companies, the US Food and Drug Administration (FDA) says it aims to be more...
UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...
UK – MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer
The combination therapy is specifically indicated for adults with advanced or recurrent endometrial cancer whose disease has progressed on or after platinum-based chemotherapy and...
UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease
The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients...
Europe – Guidance for industry to prevent and mitigate medicine shortages
EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .
Medicine...
France – Topiramate et risques chez les enfants exposés pendant la grossesse : modification...
Actualisation du 2 mai 2023
Depuis le 2 mai 2023, pour les filles, adolescentes, femmes en âge de procréer et femme enceintes :
La prescription de...
Europe – EMA annual report 2022 published
EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12...
Review of hydroxyprogesterone started
EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the...
Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
