July 9, 2016 09:13 AM EDTUpdated July 10, 02:21 PM

Why we need to lower U.S. regulatory barriers around biosimilar approvals now

The FDA’s internal review on Amgen’s biosimilar of Humira reads like a product endorsement. Posted on Friday, the agency insiders essentially said: Let’s give it …

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Why we need to lower U.S. regulatory barriers around biosimilar approvals now

This article is available only to Premium subscribers

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?

Why we need to low­er U.S. reg­u­la­to­ry bar­ri­ers around biosim­i­lar ap­provals now

This article is available only to Premium subscribers

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?

Why we need to lower U.S. regulatory barriers around biosimilar approvals now

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?