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Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto

Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.

Drug Review Regulation

Fluzone Maker Sanofi Wants Language On Failed Confirmatory Study Added To Seqirus’ Fluad Label

In new twist on debate over ‘dangling’ accelerated approvals, Sanofi wants Fluad label to reflect failure of confirmatory trial to meet primary efficacy endpoint; Seqirus says Sanofi is trying to interfere with ACIP’s possible preferential recommendation of enhanced seasonal flu vaccines in elderly.

Vaccines Review Pathway

Yo-Yo Approvals? Maybe Accelerated Approval Isn’t Fixed After All

Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.

Review Pathway Cancer

Pink Sheet Podcast: Drug Pricing Campaign Future, Lilly’s Instagram Issue, Drug Withdrawal … Or Not

Pink Sheet reporters and editors discuss whether a new report on generic drug prices will affect efforts to green-light government price negotiations, Eli Lilly’s untitled letter for promotion on Instagram, and Oncopeptides deciding to withdraw its accelerated approval withdrawal.

Pricing Debate Advertising, Marketing & Sales
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