Sandoz Group AG

A New Jersey federal court awarded Sandoz over $70 million in its lawsuit against United Therapeutics for blocking the sale of a generic hypertension drug, finding that Sandoz lost more than $137 million in profits as a result of United Therapeutics breaching a 2015 settlement agreement.

Sandoz launches first FDA-approved generic paclitaxel formulation for metastatic breast cancer, following approval on Oct. 8, 2024. The lyophilized powder for injection, developed with Jiangsu Hengrui Pharmaceuticals, is indicated for patients with metastatic breast cancer.

Skyrizi sales surpass Humira for the first time in Q3 2024, with Skyrizi sales up 50.8% to $3.205 billion and Humira down 37.2% to $2.227 billion. This shift is attributed to the rise of Skyrizi and Rinvoq, impacting adalimumab biosimilar market share despite their growth.

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB-009P. Litigations continue between Amgen and biosimilar developers Celltrion, Samsung Bioepis, and Fresenius Kabi. Sandoz's Jubbonti®/Wyost® was approved as interchangeable with Prolia®/Xgeva®.

The FDA accepted Organon and Shanghai Henlius Biotech's BLA for HLX14, a denosumab biosimilar. HLX14 is intended for osteoporosis and bone mass increase in various patient groups. The BLA is supported by comparative quality and clinical studies. Organon has exclusive commercialization rights in the US, EU, and Canada. The FDA approved the first denosumab biosimilars, Wyost and Jubbonti, in March 2024.

The 'Zollinger-Ellison Syndrome (Gastrinoma) - Global Clinical Trials Review, 2024' report by ResearchAndMarkets.com offers a comprehensive overview of clinical trials, including trial numbers, enrollment trends, and sponsor types, aiding in strategic decision-making and competitive advantage.

The 'Zollinger-Ellison Syndrome (Gastrinoma) - Global Clinical Trials Review, 2024' report, available on ResearchAndMarkets.com, offers insights into clinical trials for Zollinger-Ellison Syndrome, including trial numbers, enrollment trends, and sponsor details across regions and countries.

Evotec SE reports Q3 2024 financial results, highlighting strategic progress despite challenging market conditions. Just - Evotec Biologics shows robust growth, and new partnerships with Pfizer, BMS, and Novo Nordisk are established. The Priority Reset initiative aims for over €40m annualised adjusted EBITDA improvement. A new biologics facility in Toulouse, France, is opened, and full-year 2024 guidance is confirmed.

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.

Novartis CEO Vas Narasimhan expects company growth, emphasizing commitment to Switzerland. He projects 5% annual sales increase by 2028, driven by new medicines. Narasimhan sees no threat from patent expirations and plans to focus on core therapeutic areas for potential acquisitions. He anticipates sales and profit growth in 2025, with a current market capitalization of $230 billion. Narasimhan refutes leaving Switzerland, highlighting its role in Novartis's identity and future expansion.