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Novavax Hires Regulatory Expert As Coronavirus Vaccine Inches Closer To Emergency Use Filing

Novavax Hires Regulatory Expert As Coronavirus Vaccine Inches Closer To Emergency Use Filing

Novavax, Inc. (NASDAQ: NVAX) is beefing up its executive team as it prepares to release results of its late-stage coronavirus vaccine study and file for emergency use authorization.

What Happened: Novavax said it has appointed Dr. Henrietta Ukwu, a fellow of the American College of Physicians, to the newly created role of senior vice president, chief regulatory and quality officer.

Ukwu will be responsible for global regulatory strategy and execution as well as quality assurance for its development-stage vaccine candidates, including its COVID-19 vaccine candidate NVX-CoV2373. 

"Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021," Novavax CEO Stanley Erck said in a statement. 

Related Link: The Week Ahead In Biotech (Jan 10-16): Expect Stocks To Move As J.P. Morgan Healthcare Conference Kicks Off

Ukwu most recently served as chief regulatory officer and global head of quality and regulatory at Otsuka Pharmaceuticals, part of Otsuka Holdings Unsponsored ADR Representing Ord Shs (OTC: OTSKY).

She has led approval of many products, including Merck & Co., Inc.'s (NYSE: MRK) Varivax, a chickenpox varicella vaccine, and Crixivan, an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.

What's Next: Novavax initiated the pivotal Phase 3 study of NVX-CoV2373 in the U.S. and Mexico in late December.

The company has an ongoing Phase 3 trial in the U.K. and a Phase 2b study in South Africa. A Phase 1/2 trial is also underway in the U.S. and Australia.

The company expects to release data from these trials in the first quarter.

NVAX Price Action: Novavax shares were down 0.99% at $128.69 at last check Friday. 

Related Link: The Daily Biotech Pulse: DBV's Positive FDA Feedback, Pfizer's Cancer Drug Gets Label Expansion, Applied DNA COVID Testing Volume Surges


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Posted-In: Coronavirus Covid-19 vaccineBiotech News Health Care General Best of Benzinga

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