May 14, 2024 03:21 PM EDT

Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Nicole DeFeudis

Editor

Dynavax’s hepatitis B vaccine was rejected for a label expansion in the US after patient data was destroyed by a third-party clinical trial site operator …

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Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Nicole DeFeudis

Editor

Sign up to read this article for free.

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

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

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

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

De­struc­tion of doc­u­ments, in­suf­fi­cient da­ta lead FDA to re­ject hep B vac­cine up­date

Nicole DeFeudis

Editor

Sign up to read this article for free.

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

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

Com­pound­ed weight loss drugs have re­sult­ed in mis­dos­ing, hos­pi­tal­iza­tions, FDA warns

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

Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

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

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

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

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