Medicines prepared in pharmacies are now exempt from patent law in the Netherlands, giving pharmacists greater scope to prepare their own versions of patented medicines.
A provision of the 1995 Dutch patent law has now come into force that gives pharmacists greater scope to compound lower-cost versions of patented medicines. The move could harm access to orphan medicines, lead to more parallel imports and undermine patient safety, claims the Dutch R&D-based pharmaceutical industry lobby group, Association Innovative Medicines.
The provision is part of Article 53 of the 1995 Patent Act, which sets out exclusive rights for patent right...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
