Post by tatshensini on Aug 31, 2016 23:44:56 GMT
celltrials.info/
Not sure about copy and pasting this article, but thought many here would find it interesting. So, here is a section, with the link above.
Is cell therapy failing commercialization in Europe?
by ALEXEY BERSENEV on AUGUST 19, 2016 · 0 COMMENTS
in BUSINESS, REGULATION
Christopher Bravery – a consultant on advanced biologicals, has opened Cell Therapy Stream of the annual Bioprocessing Summit with worrisome note: “Half of approved cell and gene therapy products on European market eventually failed commercialization and were withdrawn“. Let’s look at it in details.
Since introduction of regulation cell/ gene therapy as Advanced Therapy Medicinal Products (ATMP) in 2007, seven (+1 to be) cell and gene therapy products were approved by EMA:
Chondrocelect by Tigenix in 2009
Glybera by uniQure in 2012
MACI by Genzyme/ Sanofi/ Vericel in 2013
Provenge by Dendreon in 2013
Holoclar by Chiesi in 2015
Imlygic by Amgen in 2015
Strimvelis by GSK in 2016
Zalmoxis by MolMed in 2016 (not finally approved yet as of today)
Now, let’s look at withdrawal history:
MACI’s authorization was suspended in 2014 (1 year on a market)
Provenge was withdrawn in 2015 (2 years on a market)
Chondrocelect withdrawal is starting in 2016 (7 years on a market)
So, 3/4 (75%) purely cell-based ATMPs or 3/7 (43%) of all approved ATMPs were withdrawn in the last 3 years! We can exclude Zalmoxis....