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Latest From Celltrion

Coronavirus Update: Lukewarm US Panel For Molnupiravir, Inovio, Bharat Look At Omicron

A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold. 

Coronavirus COVID-19 Approvals

Celltrion Sees Sales Dip In Q3

South Korea’s Celltrion delivered a relatively weak quarter in Q3, with a 26.9% drop in revenues despite robust sales of Truxima (rituximab) and Remsima (infliximab). The company also voiced confidence in pro-biosimilar policies introduced by the Biden administration in the US.

Sales & Earnings Biosimilars

Four Orphan Drugs Get EU Approval Recommendation

The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.

Europe Drug Review

EU Crunch Time Nears For Amgen’s Novel Lung Cancer Drug Sotorasib

The European Medicines Agency is expected to make recommendations on EU marketing authorization for 10 new medicines at its monthly meeting this week. They include products for non-small cell lung cancer, COVID-19, kidney disease, smallpox and migraine.

Europe Approvals
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