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Italy
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After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout
Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency
Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis. FDA approval of the Chiesi drug comes about five years after European regulators authorized the product.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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As muscular dystrophy drug meets key goal, Italfarmaco plans march forward to regulators
A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now plans to meet with U.S. and European authorities about seeking regulatory approval for the small molecule.
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Ovid, Angelini sign Europe licensing deal worth up to $232.5M for rare disease drug
In exchange for a $20 million upfront payment and up to $212.5 million in milestones, Italy-based Angelini will gain exclusive development, manufacturing and commercialzation rights in Europe for OV101, a drug for Angelman syndrome.
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Italy’s Menarini Group to acquire Stemline Therapeutics for $677M
New York-based Stemline won Food and Drug Administration approval in December 2018 for Elzonris, a drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN, an extremely rare but aggressive form of leukemia.
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Newly-approved Parkinson’s drug isn’t that novel
Championed as the first new chemical entity approved for Parkinson’s disease in over a decade, safinamide is really part of an existing family of drugs that have been on the market for decades.
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Devices & Diagnostics, Startups
Sleep apnea startup raises $25M, largely from Italian medtech co.
Most devices that treat sleep apnea are in the form of high-tech, oxygenated face masks […]