November 25, 2019 08:35 AM EST

Roche, PTC will now get an FDA decision on their SMA drug in 6 months — facing off with Biogen, Novartis

Amber Tong

Senior Editor

A major competitor to Biogen’s Spinraza franchise could arrive as early as this coming May, as Roche and its biotech partner obtained a priority review …

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Roche, PTC will now get an FDA decision on their SMA drug in 6 months — facing off with Biogen, Novartis

Amber Tong

Senior Editor

Sign up to read this article for free.

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

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Roche, PTC will now get an FDA de­ci­sion on their SMA drug in 6 months — fac­ing off with Bio­gen, No­var­tis

Amber Tong

Senior Editor

Sign up to read this article for free.

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?

Roche, PTC will now get an FDA decision on their SMA drug in 6 months — facing off with Biogen, Novartis

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?