Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.
Emmaus Life Sciences and Mitsubishi Tanabe Pharma have both challenged the European Medicines Agency’s view that they do not have enough proof to show that their respective drugs for sickle cell disease and amyotrophic lateral sclerosis (ALS) are fit for sale in the EU.
The EMA said yesterday that it was recommending against the approval of Emmaus’s Xyndari (glutamine), and that Mitsubishi Tanabe had withdrawn the marketing authorization application (MAA) for its product, Radicava...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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.
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.
