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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Sandoz Q3 2024 Sales Boosted by Biosimilars and Generics, Up 12% YOY
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Switzerland-based Sandoz (SWX: SDZ) has published its financial statements for the third quarter of 2024, reporting sales of USD 2.6 billion, reflecting a 12% year-on-year (YOY) increase in constant currency terms. Chemical generics contributed USD 1.854 billion in sales, marking a 4% YOY increase, while biosimilars saw a significant surge…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Sandoz Q1 2024 Results Highlight 6% Growth, Led by Biosimilars and European Strength
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Switzerland-based Sandoz (SWX: SDZ) has reported its financial results for the first quarter of 2024, announcing sales of USD 2.5 billion, marking a 6% year-on-year (YOY) increase in constant currency terms. This growth was driven by contributions from all regions. Generics sales experienced a modest 1% YOY increase to USD…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Novartis Announces Layoffs to Streamline Operations and Boost Portfolio Value
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is gearing up for a strategic restructuring that will result in the layoff of up to 680 staff members across its Swiss and US development teams. This move, reported by Endpoints News, comes on the heels of similar announcements from industry peers Bayer (ETR:…
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Gan & Lee Pharmaceuticals Commences Clinical Trial for Innovative GLP-1 Agonist GZR18
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading Chinese pharmaceutical company, has announced the commencement of dosing in a Phase I clinical study for its investigational GLP-1 receptor agonist, GZR18 tablets. This oral formulation is designed to target GPRC5D, BCMA, and CD3, and is intended to treat patients with recurrent…
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BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S.…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Sandoz Agrees to $265 Million Settlement in U.S. Generic Drug Antitrust Case
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Sandoz (SIX: SDZ), the Swiss-based pharmaceutical company, announced this week that its U.S. subsidiaries have reached a settlement in a generic drug antitrust class action, agreeing to pay $265 million to the plaintiffs. The settlement is subject to court approval and includes a provision allowing Sandoz to withdraw if a…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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Sandoz Strikes Deal to Acquire Coherus Biosimilar for Ophthalmic Treatment
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Swiss pharmaceutical company Sandoz (SWX: SDZ) has entered into an agreement to purchase Cimerli (ranibizumab), a biosimilar referencing Roche (SWX: RO) unit Genentech’s Lucentis, from US-based Coherus Biosciences (NASDAQ: CHRS). This transaction, valued at a USD 170 million upfront payment, is anticipated to conclude in the first half of 2024.…
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Aspen Pharmacare Holdings to Boost China Presence with Full Acquisition of Sandoz’s Subsidiary
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Aspen Pharmacare Holdings (JSE: APN), a South Africa-based pharmaceutical company, is poised to enhance its footprint in the Chinese market with the full acquisition of Sandoz’s (SWX: SDZ) China subsidiary, Sandoz (China) Pharmaceutical Co., Ltd. This acquisition will grant Aspen all commercial and intellectual property rights to the subsidiary’s existing…
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AbbVie Sues to Protect Rinvoq from Generic Competition in the US Market
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AbbVie (NYSE: ABBV) has initiated legal action in the US to safeguard its blockbuster drug Rinvoq (upadacitinib) from generic market entries by Switzerland-based Sandoz (SWX: SDZ) and Indian pharmaceutical companies Aurobindo Pharma (NSE: AUROPHARMA), Hetero Labs, Intas Pharmaceuticals, and Sun Pharmaceutical (NSE: SUNPHARMA). Despite holding patents on the JAK inhibitor…
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Sandoz Invests in New Biosimilars and Penicillin API Production Sites in Europe
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced the opening of two new production sites last week, marking a significant expansion of its manufacturing capabilities. One site is dedicated to biosimilars in Germany, and the other focuses on the production of penicillin active pharmaceutical ingredient (API) in Austria. Investment in…
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Sandoz Enters Euro Debt Market with $2.1 Billion Eurobond Issuance
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Switzerland-based Sandoz (SWX: SDZ), a leader in the generics and biosimilars market, has successfully entered the Euro debt capital market by issuing three inaugural Eurobond debt instruments, raising EUR 2.0 billion (USD 2.1 billion). This capital will be combined with a previous CHF issuance to repay a bridge loan of…
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Novartis Q3 Earnings Reflect Strong Growth Post-Sandoz Spinoff
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Novartis (NYSE: NVS) has released its Q3 2023 financial results, marking the first report since the company sharpened its focus on innovative medicines following the spinoff of Sandoz (SWX: SDZ) earlier this month. The financials reveal a robust performance with net sales reaching USD 34.0 billion for the first nine…
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Sandoz Becomes Independent After Spin-Off from Novartis
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Switzerland-based generic and biosimilar drug maker Sandoz (SWX: SDZ) officially became a fully independent company last week, completing its separation from Novartis (NYSE: NVS) as previously announced. The decision to spin off Sandoz was first presented in 2022, aimed at establishing a global leader in generics and biosimilars while allowing…
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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
