FDA approves RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for adults with moderate to severe rheumatoid arthritis
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- Category: Amgen
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
Sandoz announces new global 'Act4Biosimilars' initiative
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- Category: Novartis
Sandoz, a global leader in generic and biosimilar medicines, announced the launch of a new global initiative called 'Act4Biosimilars' to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A's) of biosimilars.
GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones. Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.
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.
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