July 20, 2016 08:03 AM EDT

AveXis wins the inside track at the FDA with gene therapy ‘breakthrough’

Arsalan Arif

Founder

Chicago-based AveXis has lined up the latest breakthrough therapy designation from the FDA, gaining an inside track at the agency for its early-stage gene …

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AveXis wins the inside track at the FDA with gene therapy ‘breakthrough’

Arsalan Arif

Founder

Sign up to read this article for free.

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Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?

AveX­is wins the in­side track at the FDA with gene ther­a­py ‘break­through’

Arsalan Arif

Founder

Sign up to read this article for free.

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

AveXis wins the inside track at the FDA with gene therapy ‘breakthrough’

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?