Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU. The EMA is also concerned that unexpectedly high staff losses will seriously affect its ability to operate.
The European Medicines Agency has suspended a number of regulatory activities, including development of the new medicines web portal and work on the e-submission project, and is cutting back on meetings and conferences, to allow it to focus on addressing the implications of its forced relocation out of the UK.
The agency has also issued a stark warning that if levels of job losses resulting from its Brexit-related move to another EU member state are more far-reaching than expected, it...
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
