Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.
Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.
The agreement on trade and cooperation between the UK and the EU requires both sides to offer regulatory data exclusivity and supplementary protection certificates, but it does not specify any minimum periods of protection.
As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.
Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.