Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer
GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company’s development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, 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,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We welcome
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ConnectiveRx Strengthens Leadership
WHIPPANY, N.J. (BUSINESS WIRE) Jan 7, 2021
ConnectiveRx, a leading provider of technology-enabled patient support and access solutions for specialty and branded medications, today announced the company is strengthening its leadership to support rapid growth with the appointment of David Wheadon, MD, as member of the company’s board of managers and Jim Corrigan as president.
“David and Jim have exceptional track records for leadership and strategic innovation in the pharmaceutical and greater healthcare sectors,” said ConnectiveRx CEO Harry Totonis. “Their addition to our organization enhances our ability to meet the evolving needs of our pharmaceutical manufacturer partners.”
Seelos Therapeutics Announces Year End 2020 Business Update
-Highlights of Continued Execution of Plans for Multiple Clinical Programs and Upcoming Catalysts
-Additions to the Clinical, Operational and Regulatory Teams
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NEW YORK, Jan. 6, 2021 /PRNewswire/ Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year end 2020 business update. This past year marked the most significant 12 months in Seelos Therapeutics history despite being an otherwise challenging year due to the COVID-19 pandemic. We completed our safety trial for the intranasal ketamine program and began opening centers for our pivotal trial for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. The trehalose program s pivotal study in ALS was accepted into the HEALEY ALS Platform
COVID-19: What is an Emergency Use Authorization?
Dec. 14, 2020
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Sponsored by Pfizer.
According to the FDA, an Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
1 An EUA allows the use of medical products, not yet approved, when there are no adequate, approved and available alternatives.
2
Since the start of the COVID-19 pandemic, the FDA has issued EUAs for select medical products and drugs it believes may help address the impact of the virus on the American public.
3
What are the criteria for a COVID-19 vaccine candidate to receive an EUA?