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.
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.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
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.
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.
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.
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.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
Most devices that treat sleep apnea are in the form of high-tech, oxygenated face masks – but a Minnesota startup is taking a different approach, building an implantable device that treats the common breathing disorder. Respicardia has raised $25 million, with about $20 million of that coming from the Milan-based Sorin Group. The Italian cardiac devicemaker which […]
Despite being separated by a big body of water and quite a few language barriers, there are few shared struggles in healthcare between the US and Europe. An Economist article highlighting the rise of telemedicine in the European Union calls attention to the issue of reimbursement and implementation in its member countries. As the article […]