Novavax’s Nuvaxovid COVID-19 Vaccine Gets Expanded EUA In Taiwan For Use In Adolescents

Alan Alda on ‘M*A*S*H’: ‘Everybody Had Something Taken From Them’

As the acclaimed “situation tragedy” turns 50, the star reflects on its innovations: “The crazy behavior wasn’t just to be funny. It was a way of separating yourself for a moment from the nastiness.”

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By Saul Austerlitz

Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 as well as pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).

The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.

This positive opinion was based on results from the ongoing CARAVAN Phase 2/3 study, which demonstrated Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.

‘M*A*S*H’ at 50: War Is Hell(arious)

Five decades ago, “M*A*S*H” anticipated today’s TV dramedies, showing that a great comedy could be more than just funny.

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By James Poniewozik

What’s So Frightening About Identical Twins?

“The Silent Twins,” a new film starring Letitia Wright and Tamara Lawrance, sets out to show the complexity of twinship onscreen.

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By Charlie Brinkhurst-Cuff

Huntsman Revises Q3 Adj. EBITDA From Cont. Ops. Guidance

Huntsman Corp. (HUN) said the company now expects third quarter adjusted EBITDA from continuing operations to be between $260 million and $280 million. Previously, the company estimated third-quarter adjusted EBITDA between approximately $310 million and $355 million, excluding Textile Effects.

The company said it remains on track to exceed previously announced cost optimization and synergy program and expect to deliver an annualized run rate of approximately $170 million by year-end. Also, the company is evaluating further cost reduction and optimization opportunities.

Peter Huntsman, CEO said: “Huntsman is feeling the same pressures as others in the industry as we are being impacted by persistent and extraordinary cost of energy in Europe, together with lower than expected demand across segments in our portfolio, primarily within Polyurethanes and Performance Products. The economy in China continues to lag our expectations due to continued Covid-related lockdowns. While the United States remains our most resilient market, demand in residential housing has slowed.”

Shares of Huntsman Corp. are down 5% in pre-market trade on Friday.

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Novavax’s Nuvaxovid COVID-19 Vaccine Gets Expanded EUA In Taiwan For Use In Adolescents

Biotechnology company Novavax, Inc. (NVAX) announced Friday that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

The EUA is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid.

In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S

The preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.

The TFDA previously granted EUA for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in June 2022.

In the 12 through 17-year-old population, the vaccine has been authorized in more than 10 markets including the U.S., the European Union, and the United Kingdom (U.K.).

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