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Regulatory NEWS
First to market with an all-oral first-line therapy for adults with Gaucher disease type 1, the most common form, is the Genzyme unit of Paris-based Sanofi SA, which gained FDA marketing clearance for Cerdelga (eliglustat), giving patients an option to the infused enzyme replacement therapy (ERT) Cerezyme (imiglucerase), also developed by Genzyme.
LONDON – With the number of biosimilars approved in Europe on the rise, the UK Bioindustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) have joined forces in a publicity campaign to ensure prescribers are aware that – unlike small-molecule generics – biosimilars are not straight swaps for the originator products.
DUBLIN – It's not a bad parting gift to receive as you exit the sector. Shares in synthetic biology specialist Evolva Holding SA got a 9 percent boost Thursday on news that it landed a $6.5 million contract from the U.S. Defense Threat Reduction Agency (DTRA) to carry out preclinical research on its GC-072 program.
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