Dostarlimab, Zynteglo & COVID-19 Combo Drugs In The Spotlight At EMA
The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
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Zynteglo Authorization Renewal Paused While EU Regulators Examine Safety Concerns
The European Medicines Agency is reviewing the safety of bluebird bio’s beta thalassaemia gene therapy, which is so far only approved in the EU and has only been used in one patient outside the context of clinical studies.
First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
Bluebird Sickle Cell Gene Therapy Hangs In Balance
The company will likely have its answer in a matter of weeks, but a link to the vector would be a “worst-case scenario.”