Start-Up Previews (9/03)
A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, Therapeutics for Autoimmune Disorders, features profiles of Bayhill Therapeutics Inc., Can-Fite Biopharma Ltd. and Opexa Pharmaceuticals Inc. Plus these Start-Ups across Health Care: Bionaut Pharmaceuticals Inc., SkinMedica Inc., Vivant Medical Inc. and ZelleRx Corp.
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Piqray is now approved for use in 50 countries but not only did the novel breast cancer drug take longer to be approved in the EU than in the US, its indication is narrower in the EU.
The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."
To build a “reliable long-term domestic production” of medicines and related supplies and to “minimize potential shortages,” US President Donald Trump has signed a ‘Buy American’ executive order. However, the move has left industry wondering if it is a sustainable solution.