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Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer | Comunicados | Edición USA

15 ene 2021
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 Office ....

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Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine | Comunicados | Edición USA

Advance Purchase Agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate
Initial doses expected to be delivered as early as mid-2021
GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M™ to enhance the immune response.
Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large pivotal Phase 3 clinical trials in the United States/Mexico (the PRE ....

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Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico

Trial | COVID
-19) is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.
The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. ....

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Biopharma Executive Rick Crowley Joins Novavax as Chief Operations Officer – IT Business Net

Biopharma Executive Rick Crowley Joins Novavax as Chief Operations Officer
GAITHERSBURG, Md., Dec. 21, 2020 (GLOBE NEWSWIRE) Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Rick Crowley to the newly created position of Executive Vice President, Chief Operations Officer. In this role, Mr. Crowley will have leadership responsibility for all operations, including Quality, Manufacturing, Supply Chain and Regulatory Affairs. He takes over manufacturing from Ben Machielse, who will continue with the company as an executive advisor to the Chief Executive Officer, supporting the development of the COVID vaccine.
“Rick’s wealth of biopharmaceutical experience and record of on-time FDA approvals comes at the perfect time to help ensure that Novavax delivers on our global manufacturing mission and supply commitments,” said Stanley C. Erck, Novavax Preside ....

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Biopharma Executive Rick Crowley Joins Novavax as Chief Operations Officer

Biopharma Executive Rick Crowley Joins Novavax as Chief Operations Officer
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