COVID vaccine protection wanes within six months - UK researchers

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Pfizer (PFE) and BioNTech(BTNX) Partner With Eurofarma Laboratórios to Manufacture COVID-19 Vaccine in Latin America

August 26, 2021 6:47 AM EDT

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America.

Eurofarma will perform manufacturing activities within Pfizers and BioNTechs global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarmas involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately.... More

AstraZeneca's (AZN) Forxiga is Approved in Japan for Chronic Kidney Disease Treatment

August 26, 2021 5:37 AM EDT

AstraZeneca (NASDAQ: AZN) announces that Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The approval by Japans Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial.1 The decision follows the Priority Review designation granted by the MHLW... More

Alexion's (AZN) ALXN1840 FoCus Phase III trial Met Primary Endpoint

August 26, 2021 5:35 AM EDT

AstraZeneca's (NASDAQ: AZN) Alexion announces positive high-level results from the FoCus Phase III trial in Wilson disease.

ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.

The primary endpoint gauged the daily mean Area Under the Effect Curve (AUEC) for directly measured non-ceruloplasmin-bound copper (dNCC) over 48 weeks. This novel measure assesses the daily mean copper mobilised from tissues, reflecting the underlying burden of the copper accumulation.

Wilson disease is a rare and progressive genetic... More

Moderna, Inc’s (MRNA) Vaccine’s FDA Approval Could Lead to Greater Market Share in Coming Years - Analyst

August 25, 2021 1:09 PM EDT

Earlier today, Moderna, Inc. (Nasdaq: MRNA) announced it has completed the rolling submission process for its Biologics... More