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Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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Organon Inks Deal to Acquire Dermavant, Bolstering Dermatology Portfolio with Vtama Cream
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US healthcare company Organon (NYSE: OGN) has announced a definitive agreement to acquire Dermavant, a Roivant (NASDAQ: ROIV) subsidiary focused on dermatological treatments. The acquisition is primarily driven by Dermavant’s Vtama (tapinarof) cream, a 1% topical formulation approved for plaque psoriasis and currently under regulatory review for atopic dermatitis (AD).…
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Organon’s Q2 2024 Revenues Grow 2% YOY, Sets Sights on Fertility Business Rebound in 2025
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Organon (NYSE: OGN), a U.S.-based pharmaceutical company, has reported its financial results for the second quarter of 2024, with revenues amounting to USD 1.607 billion, marking a modest growth of 2% year-on-year (YOY) in constant currency terms. This performance aligns with market expectations and keeps the company on track to…
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Organon’s Liptruzet Launches in China for Hypercholesterolemia Treatment
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US pharmaceutical company Organon (NYSE: OGN) has announced the official market launch of its single-tablet compound preparation Liptruzet (ezetimibe, torvastatin) in China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). The launch marks a significant step in addressing the lipid management needs of Chinese patients. Liptruzet combines the…
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Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Organon’s Q1 2024 Revenues Rise 7% YOY, Women’s Health and Biosimilars Lead the Way
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Organon (NYSE: OGN), a leading women’s health specialist, announced a 7% year-on-year increase in revenues for the first quarter of 2024, reaching $1.6 billion, excluding the impact of foreign exchange. This growth was primarily fueled by a robust performance in Women’s Health and Biosimilars segments, which saw revenues surge 12%…
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Organon Reports Q4 2023 Revenue Growth Driven by Women’s Health and Biosimilars
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Organon (NYSE: OGN), the U.S.-based pharmaceutical company, has reported its fourth-quarter 2023 financial results, revealing a 3% year-on-year increase in global revenues, reaching USD 6.3 billion in constant currencies. The company’s performance showed marked improvement, with Q4 revenues climbing 8% year-on-year to USD 1.6 billion. Breaking down Q4 performance by…
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Organon In-Licenses Eli Lilly’s Emgality and Rayvow for European Migraine Market
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Organon (NYSE: OGN), a specialist in women’s health, has in-licensed migraine treatments Emgality (galcanezumab) and Rayvow (lasmiditan) from U.S. partner Eli Lilly (NYSE: LLY) for the European market. Under the agreement, Lilly will receive an upfront payment of $50 million, along with milestone payments, pending regulatory approval expected in Q1…
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Shanghai Qingyun Pharmaceutical Teams Up with Organon at CIIE for Remeron Marketing
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China’s Shanghai Qingyun Pharmaceutical Technology Co., Ltd has entered into a partnership with US-based Organon (NYSE: OGN) during the 6th China International Import Expo (CIIE) in Shanghai. The collaboration is centered around Organon’s Remeron (mirtazapine), with Qingyun playing a role in implementing omnichannel marketing strategies for the drug. Mirtazapine’s Mechanism…
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Organon Reports Q3 2023 Financials with Mixed Results, Notable Decline in Women’s Health Sales
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US-based Organon (NYSE: OGN) has released its financial results for the third quarter of 2023, showing a 1% year-on-year (YOY) decrease in sales to USD 1.519 billion in constant currency terms. The company’s performance was marked by a 7% decline in Women’s Health sales to USD 418 million, a 10%…
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Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
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US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
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Cordavis Launches First Biosimilar: Novartis’ Hyrimoz to Compete with Humira
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Swiss pharmaceutical giant Novartis (NYSE: NVS) unit Sandoz’s biosimilar product, Hyrimoz (adalimumab), which references AbbVie’s (NYSE: ABBV) Humira, has been announced as the first product offered by Cordavis, a newly launched biosimilars-focused subsidiary of US health solutions company CVS Health (NYSE: CVS). The biologic is planned for launch during Q1…
