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Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Europe Approvals

Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA

The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.  

Europe Approvals

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 The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.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
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