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The EMA Turns 20: What Does It Want to Be?
The European Medicines Agency (EMA) is 20 years old this year - and it confronts many of the problems familiar to anyone at that age.
The European Medicines Agency (EMA) is 20 years old this year - and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its early adolescence, the agency now must make up its mind about what it wants to be.
This is not just a matter of defining its personality. It also means taking on greater responsibility obtaining the resources it will need, and asserting its mission successfully in the face of the often harsh realities of the outside world.
The agency’s own sharpened awareness of the complex conditions beyond Canary Wharf, London, offices is its programme for 2014, which identifies half a dozen new priorities. As EMA’s executive director, Guido Rasi, publicly observed at the end of last year, “The environment in which we are operating is ever-changing, continuously presenting us with new challenges.”
For Reflector’s incisive look at the EMA’s growing pains as it faces the key policy challenges of 2014, see February’s issue of Pharmaceutical Executive, or click here.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
