Commentary
AMT fails to get marketing authorization for Glybera
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- Category: Editorial Team
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- Written by Administrator
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Gene therapy suffered another blow, when Dutch biotech company Amsterdam Molecular Therapeutics, AMT, got another negative opinion for it's lead drug Glybera. The opinion was already a second for Glybera, since the company got first negative opinion in July 2011 and asked for re-examination from EMA.
Interestingly, this time the company got a positive opinion from CAT, Committee of Advanced Therapies, which might indicate that the product was deemed safe and effective, but CHMP, The Committee for Medicinal Products for Human Use, voted to yield a negative decision.
Read more: AMT fails to get marketing authorization for Glybera
ARK fails to get MAA for Cerepro
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- Category: Editorial Team
- Published Date
- Written by Administrator
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Today Ark released the negative opinion of EMEA for it's crucial Cerepro- drug.
"The main underlying objection from the regulator which had not been resolved concerns specifically whether or not patients treated with Cerepro® might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro®. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend approval based on the data presented by Ark so far. The CHMP has thus adopted a negative opinion as Ark had not at that point in time provided trial evidence beyond doubt that Cerepro® has demonstrated adequate efficacy."
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