At the European Medicines Agency's second ever public hearing on the safety of marketed medicines, patients gave an emotional account of how they battled with 'ignorance' within the EU medical community about the severely debilitating and potentially permanent side-effects of some broad-spectrum antibiotics.
For Elizabeth Carmouche, a last-minute trip to her general practitioner to get some medicines before she left for a three-week holiday in March 2016 has been a life-changing event. She was given ciprofloxacin, a widely-prescribed antibiotic, "just in case" she got a urinary tract infection or traveller's diarrhoea.
Carmouche, who is from Belgium, occasionally suffers from UTIs, so her doctor had suggested that she should take ciprofloxacin instead...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
