Weekly Quick Hits (BioHealth Capital Region) – Week of May 8, 2023

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Weekly Quick Hits (BioHealth Capital Region) – Week of May 8, 2023 By Sarah EllinwoodMay 12, 2023 Funding, Awards and Collaborations Maryland Stem Cell Research Commission (MSCRF) Announces Over $14 [….]

BioHealth Capital Region Q1 2023 News Recap – We Get Knocked Down, But We Get Up Again

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BioHealth Capital Region Q1 2023 News Recap – We Get Knocked Down, But We Get Up Again By Sarah EllinwoodApril 11, 2023 Now that I got that 90s earworm in [….]

Novavax Names John C. Jacobs as New President & Chief Executive Officer

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Novavax Names John C. Jacobs as New President & Chief Executive Officer
Jan 9, 2023
Current President & CEO Stanley C. Erck will retire effective January 23 with plans to support the leadership transition in an advisory capacity
Novavax is well-positioned to execute on its strategy, with global authorizations for its COVID-19 vaccine and continued clinical pipeline development
GAITHERSBURG, Md., Jan. 9, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that John C. Jacobs will succeed Stanley C. Erck as President and Chief Executive Officer and a member of the Board of Directors. The transition will be effective as of January 23, 2023. Mr. Erck will serve as an advisor to the Company for the next fifteen months to enable a smooth transition.
“As we prepare for Stan’s retirement, the Board reflects on the incredible legacy he leaves behind,” said James F. Young, PhD, Chairman of the Board of Directors. “Stan led Novavax from a clinical development organization to a global commercial vaccines company during a worldwide pandemic. This foundation puts Novavax in a strong position to execute on its long-term strategy, and we look…

FDA Authorizes Novavax COVID Vaccine for Adults

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FDA authorizes Novavax Covid vaccine for adults as the first new shots in U.S. in more than a year
PUBLISHED WED, JUL 13 20224:24 PM EDTUPDATED WED, JUL 13 20224:48 PM EDT
Spencer Kimball
@SPENCEKIMBALL
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KEY POINTS
FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.
The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA.
Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed.
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NVAX
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In this photo illustration the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vials.
Pavlo Gonchar | LightRocket | Getty Images
The Food and Drug Administration has authorized Novavax’s two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began.
The…

FDA Advisors Vote 21-0, with One Abstention, to Authorize Novavax’s Covid-19 Vaccine to be the Fourth US Option

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A pan­el of FDA’s out­side ex­perts rec­om­mend­ed 21 to 0, with one mem­ber ab­stain­ing, that the agency give emer­gency use au­tho­riza­tion for No­vavax’s two-dose Covid-19 vac­cine for peo­ple aged 18 years and old­er.
The ad­vi­sors’ vote of con­fi­dence was de­liv­ered days af­ter the FDA’s sci­en­tists de­ter­mined the vac­cine to be ef­fec­tive but with the caveat of po­ten­tial rare heart in­flam­ma­tion. Last au­tumn, pre-Omi­cron, the vac­cine was found to have a 90.4% ef­fi­ca­cy in a tri­al com­pris­ing 17,272 peo­ple giv­en a vac­cine and 8,385 peo­ple giv­en a place­bo.
“The Ad­vi­so­ry Com­mit­tee’s pos­i­tive rec­om­men­da­tion ac­knowl­edges the strength of our da­ta and the im­por­tance of a pro­tein-based COVID-19 vac­cine de­vel­oped us­ing an in­no­v­a­tive ap­proach to tra­di­tion­al vac­cine tech­nol­o­gy,” CEO Stan­ley Er­ck said in a state­ment. “We have heard in to­day’s VRB­PAC meet­ing the sig­nif­i­cant sup­port for our vac­cine from physi­cians, health­care or­ga­ni­za­tions, and con­sumers who are ea­ger­ly an­tic­i­pat­ing a pro­tein-based vac­cine op­tion. We look for­ward to the FDA de­ci­sion.”

Initial Results from Novavax’ COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

Novavax logo
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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.