February 16, 2024 01:56 PM EST

Biopharma manufacturers call for clarity on FDA's advanced designation guidance

Anna Brown

News Reporter

Pharma companies are expressing fears that the FDA’s new advanced manufacturing tech designation guidance could “burden” the agency, according to comments recently made public. …

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Biopharma manufacturers call for clarity on FDA's advanced designation guidance

Anna Brown

News Reporter

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

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Bio­phar­ma man­u­fac­tur­ers call for clar­i­ty on FDA's ad­vanced des­ig­na­tion guid­ance

Anna Brown

News Reporter

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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?

Biopharma manufacturers call for clarity on FDA's advanced designation guidance

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?