Author Archive: AZBio

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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  • Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination
  • 85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28
  • Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage [1] Observed in South Africa
  • Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting

[1] The B.1.351 lineage also known as 501Y.V2 variant and 20H/501Y.V2 (formerly 20C/501Y.V2) is a variant of SARS-CoV-2, the virus that causes COVID-19Continue reading→

Equality Health and General Atlantic Announce Strategic Partnership to Help Drive Continued Expansion of Equality’s Value-Based Primary Care Network and Technology Solutions

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Strategic investment from General Atlantic to help enable Equality Health in furthering its mission of increasing access to care, lowering costs and improving outcomes for underserved individuals, families and communities

Equality Health to acquire actuarial firm, Daraja Services, to deepen healthcare economics capabilitiesContinue reading→

Opportunty Alert: EMERGEAZ Fast Grants

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In partnership with the Arizona Governor’s Office, invisionAZ and StartupAZ are offering financial support to the state’s startups through the EMERGEAZ Fast Grant. Local entrepreneurs and startups with emerging technologies designed to address the impacts of the pandemic are encouraged to apply. There is a total of $1 million in the fund and grants will be awarded in amounts ranging from $25,000 to $50,000.Continue reading→

FDA Releases Final Rule on the Safer Technologies Program for Medical Devices (STeP)

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The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products1 that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.

Learn about the  Safer Technologies Program for Medical Devices (STeP) program 

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Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine

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January 13, 2021 — Interim Phase 1/2a data were published today in the New England Journal of Medicine demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.

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