FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment.
Roche develops unique PCR tests to detect the monkeypox virus
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed three unique LightMix® Modular Virus kits in response to recent monkeypox virus concerns. Multiple clusters of the monkeypox virus have been reported within the past two weeks in several European countries and North America, which are regions where the virus is not normally found.
Vaxzevria approved in the EU as third dose booster against COVID-19
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- Category: AstraZeneca
AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.
Healthcare professionals can now use Vaxzevria as a third dose booster in patients previously given a primary vaccine schedule of either Vaxzevria or an EU-approved mRNA COVID-19 vaccine.
Pfizer 'aunches 'An Accord for a Healthier World' to improve health equity for 1.2 billion people living in 45 lower-income countries
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today launched 'An Accord for a Healthier World.' This groundbreaking initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the U.S. or the European Union on a not-for-profit basis to 1.2 billion people in 45 lower-income countries. The Accord seeks to greatly reduce the health inequities that exist between many lower-income countries and the rest of the world.
Roche enters partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure
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Roche (SIX: RO, ROG; OTCQX: RHHBY), through its Global Access Program, and The Global Fund to Fight AIDS, Tuberculosis and Malaria are joining forces to build and strengthen diagnostic capacity and pandemic preparedness in low-and middle-income countries fighting against HIV and tuberculosis (TB).
Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine
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- Category: Business
The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics.
It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7 million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths.
Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
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- Category: Business
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine.
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