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Curis, Inc.

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Latest From Curis, Inc.

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

COVID-19 Vaccines: Ocugen’s EUA Request For Covaxin In Kids Faces Steep Climb At US FDA

Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.

Coronavirus COVID-19 Vaccines

Dr Reddy’s Gears For Sputnik Pediatric Shot, Molnupiravir Upside

Dr Reddy’s indicates it is close to break-even between “the investment made and what we gained” for Russian COVID-19 vaccine Sputnik V in India, with Sputnik Light, boosters and pediatric shots seen as the new growth drivers. The company’s fully vertically integrated operations also puts it in prime position for supplies of antiviral molnupiravir.

Coronavirus COVID-19 Vaccines

Coronavirus Notebook: WHO OKs Bharat’s Covaxin, AZ Pulls Swiss Vaxzevria Filing

The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.

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