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S. Korea Approves Novavax COVID-19 Vaccine

S. Korea Approves Novavax COVID-19 Vaccine

SEOUL, Jan. 12 (Korea Bizwire) — South Korea’s drug safety agency on Wednesday authorized the use of U.S.-based biotechnology company Novavax Inc.’s COVID-19 vaccine. The protein-based vaccine, Nuvaxovid, marks the fifth COVID-19 vaccine to get approval for use here, following the ones by British-Swedish pharmaceutical giant AstraZeneca and Oxford University, Pfizer Inc., Johnson & Johnson [...]

SK Bioscience Extends Manufacturing Deal with Novavax Through 2022

SK Bioscience Extends Manufacturing Deal with Novavax Through 2022

SEOUL, Dec. 24 (Korea Bizwire) — SK Bioscience Co., a vaccine unit of South Korea’s SK Group, said Friday it has extended an agreement to manufacture a component of the U.S.-based biotechnology company Novavax Inc.’s COVID-19 vaccine by one more year. Under the extended agreement, SK Bioscience will reserve additional manufacturing capacity to produce antigen, [...]

Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico

Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico

GAITHERSBURG, Md., Feb. 22 (Korea Bizwire) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of the company’s COVID-19 vaccine. Novavax has previously reported positive interim [...]

Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine

Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine

GAITHERSBURG, Md., Feb. 18 (Korea Bizwire) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax’ recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility. The vaccine doses [...]

Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea

Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea

GAITHERSBURG, Md., Feb. 15 (Korea Bizwire) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, and SK Bioscience, a vaccine business subsidiary of SK Group, today announced an expanded collaboration and license agreement. In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and [...]

Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization

Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization

GAITHERSBURG, Md., Feb. 4 (Korea Bizwire) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in [...]

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

GAITHERSBURG, Md., Jan. 28 (Korea Biziwre) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed [...]

Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer

Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer

GAITHERSBURG, Md., Jan. 15 (Korea Bizwire) — 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 [...]