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Teva Leads Generic Rivals In First-To-File ANDAs By A Long Shot

 
• By Jessica Merrill

Teva has submitted 13 ANDAs with first-to-file opportunities to FDA this year, while rivals Mylan, Endo, Sandoz and Indian firm Hetero each have filed two ANDAs with FTFs, according to public data released by the agency and further analyzed by Teva.

Teva Pharmaceutical Industries Ltd. has a substantial lead over its generic competitors on first-to-file abbreviated new drug applications in the US. Teva has filed 13 such applications with FDA this year as of Sept. 7, while generic drug manufacturers Mylan NV,Endo International PLC and Sandoz Pharma Ltd. have each submitted two.

Teva paraded the updated ANDA data before investors during a presentation Sept. 9 in New York as a show of its pipeline strength (see tablebelow). The company held the investor...

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More from Approvals

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Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
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The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

More from Product Reviews

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.