CHMP advises approval for Bristol Myers Squibb’s Opdivo plus Yervoy with chemo for metastatic NSCLC
The European Commission will now review the CHMP recommendation
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European Medicines Agency
EU approves AstraZeneca’s Imfinzi for treatment of extensive-stage small cell lung cancer
Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is also approved in the US, Japan and several other…
EMA finalises opinion on presence of nitrosamines in medicines
Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where…
Emer Cooke nominated as new EMA Executive Director
Emer Cooke is currently the Director of the Regulation and Prequalification Department at the World Health Organization (WHO) in…
Safe and effective vaccination should be given high priority: EMA
The two ICMRA statements aim to reassure healthcare professionals and the public around the globe that medicines regulators only…
Global regulators commit to cooperate on observational research during COVID-19 pandemic
At the second workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19,…
Remdesivir close to EU’s initial authorisation as COVID-19 treatment
The European Medicines Agency (EMA) has already recommended the compassionate use of remdesivir, which allows a drug to be…
Orphan drugs face uphill battle in 2020: GlobalData
ODDs have been a focus of interest from the pharma industry for many years, with many companies enticed by the benefits of the…
Roche says Tecentriq prevents disease worsening or death in patients with advanced bladder cancer
Roche is evaluating treatment in combination with other medicines for early, advanced forms of disease
India is a key focus country under renewed global strategy
Sandra de Wild Charonnens, Strategic Advisor, Life-Science & Health, NFIA, informs
why the Netherlands is an attractive…