February 18, 2022 09:25 AM EST

BioMarin gene therapy could be on hold 'for several quarters' after FDA mandates new preclinical tests

Jason Mast

Editor

The FDA is staying cautious after data came out suggesting that one of BioMarin’s experimental gene therapies might have the potential to drive cancers. …

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BioMarin gene therapy could be on hold 'for several quarters' after FDA mandates new preclinical tests

Jason Mast

Editor

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

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

Bio­Marin gene ther­a­py could be on hold 'for sev­er­al quar­ter­s' af­ter FDA man­dates new pre­clin­i­cal tests

Jason Mast

Editor

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

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

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

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?

BioMarin gene therapy could be on hold 'for several quarters' after FDA mandates new preclinical tests

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

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

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

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?