Kerendia™ (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
The European Commission granted approval for a label extension for Kerendia™ (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D.
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GSK announces results from 17-year retrospective study on US clinical trial diversity
GSK plc (LSE/NYSE: GSK) announced results from a retrospective study on clinical trial diversity, investigating the historical representation of US-based participants in GSK clinical trials. The study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the period 2002 to 2019.
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2022 Otto Bayer Award goes to Professor Frank Glorius
The Bayer Foundation has presented the Otto Bayer Award, complete with its prize money of 75,000 euros, to Professor Frank Glorius. The research scientist at the University of Münster received the award in recognition of the development of an extensive array of groundbreaking catalytic reactions for organic synthesis, facilitating the sustainable synthesis of organic molecules with high levels of selectivity and purity that offer outstanding value for medical and agricultural applications.
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Pfizer reports record full-year 2022 results
Pfizer Inc. (NYSE: PFE) reported exceptional financial results for fourth-quarter and full-year 2022 and provided 2023 financial guidance. Full-year 2022 revenues of $100.3 billion, an all-time high for Pfizer, reflecting 30% operational growth (excluding contributions from Paxlovid and Comirnaty, revenues grew 2% Operationally).
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AMJEVITA™ (adalimumab-atto), first biosimilar to Humira® now available in the United States
Amgen (NASDAQ:AMGN) today announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.(1,2)
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CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
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Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus.
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