Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...
Europe – EMA offers insights on when biologics qualify as new active substances
The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances...
Europe – DARWIN EU® welcomes first data partners
EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. The data available to these...
Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
The recommendation is specifically for adults with the immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those...
USA – mRNA technology for universal flu vaccine shows early promise in US study
The World Health Organization cites vaccination as the current principal means of reducing or counteracting influenza mortality and morbidity burden, but the constantly evolving...
UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers
Specifically, NICE’s recommendation is extended to patients with untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma if the tumours express PD-L1...
UK – NHS fast tracks life-extending prostate cancer drug to patients
Around 9,000 men with one of the most advanced forms of prostate cancer will be eligible for a new life-extending treatment thanks to a...
Europe – Respiratory vaccination candidate tested in German hospitals
Researchers are investigating whether the vaccine candidate VPM1002 – originally developed against tuberculosis by scientists at the Max Planck Institute for Infection Biology, Berlin...
Europe – EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and,...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November –...
EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults...
