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In The Clinic NEWS

A partial restriction on tests of an experimental and well-financed gene therapy for Duchenne muscular dystrophy (DMD) gave way to a full FDA clinical hold following a serious adverse reaction in the first patient dosed. The boy has since recovered. 

Alexion Pharmaceuticals Inc. is looking to the second half of 2018 as the target for regulatory filings in the U.S., EU and Japan after ALXN-1210, its long-acting C5 complement inhibitor, hit noninferiority to Soliris (eculizumab) across co-primary and the four key secondary endpoints in the pivotal phase III Study 301 in complement inhibitor treatment-naïve patients with PNH.

With regulatory support from the EMA and financial backing from the European Investment Bank, Biondvax Pharmaceuticals Ltd. moved a step closer to initiating the pivotal phase III trial of its universal flu vaccine candidate, Multimeric-001, by putting a master service agreement in place with a CRO for the trial, expected to begin in the third quarter.

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