
Crypto Investment Entry and Exit Strategies of Institutional Investors
Section: Business
The European Medicines Agency's (EMA) Committee for Human Medicinal Products has issued a favorable recommendation for the approval of Nirogacestat, aimed at treating adults with progressive desmoid tumors who require systemic therapy. Desmoid tumors, which arise from the proliferation of differentiated myofibroblasts, are classified as benign soft tissue tumors and are known for their rarity and heterogeneity, complicating treatment options.
Nirogacestat was previously granted approval in the United States in November 2023. The applicant, Spring Works Therapeutics Ireland Limited, plans to introduce the Nirogacestat-containing medication Ogsiveo® in European markets, available in film-coated tablets with dosages of 50 mg, 100 mg, and 150 mg.
This medication operates as a ?-secretase inhibitor, targeting a novel mechanism. By inhibiting this enzyme, Nirogacestat prevents the proteolytic activation of Notch receptors, which play a significant role in tumor formation and growth.
According to the EMA, Ogsiveo demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo in a Phase III clinical trial involving adults with progressive desmoid tumors. The most common adverse effects reported include diarrhea, rash, ovarian toxicity in women of childbearing age, nausea, fatigue, hypophosphatemia, headaches, and mucosal inflammation.
The final decision regarding Nirogacestat's approval in the European Union now rests with the European Commission. Typically, this process is a formality, as the Commission generally aligns with the EMA's recommendations.
Section: Business
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Section: Health
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Section: News
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Health Insurance in Germany is compulsory and sometimes complicated, not to mention expensive. As an expat, you are required to navigate this landscape within weeks of arriving, so check our FAQ on PKV. For our guide on resources and access to agents who can give you a competitive quote, try our PKV Cost comparison tool.
Germany is famous for its medical expertise and extensive number of hospitals and clinics. See this comprehensive directory of hospitals and clinics across the country, complete with links to their websites, addresses, contact info, and specializations/services.
One of the most beautiful squares transforms into a summer stage every year for two days. The Gärtnerplatz Open-Air features a free music and cultural program across three stages, as well as street food from local vendors. On Saturday, the main stage at Gärtnerplatz offers something for everyone,...
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