June 1, 2018 04:11 PM EDTUpdated June 2, 11:27 PM

FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan

Brittany Meiling

In a somewhat unsurprising setback, Amgen $AMGN and its partner Allergan got snubbed by the FDA Friday on the duo’s biosimilar application for their Herceptin …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan

Brittany Meiling

Sign up to read this article for free.

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

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

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?

FDA stalls yet an­oth­er Her­ceptin copy­cat, is­su­ing re­sponse let­ter to Am­gen/Al­ler­gan

Brittany Meiling

Sign up to read this article for free.

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

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

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?

FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan

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

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

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?