US FDA to provide funding for paediatric device development
This article was originally published in RAJ Devices
Nonprofit consortia that wish to receive a grant from the US Food and Drug Administration for developing paediatric medical devices have until 15 June to submit their applications1. The agency has announced the availability of some $2 million for fiscal year 2009 under its Pediatric Device Consortia Grant Program, which is run by the FDA Office of Orphan Products Development.
You may also be interested in...
Japanese companies agree to discontinue regenerative cell therapy pact after high-profile Phase II failure, but SanBio will move ahead with development and Dainippon will hold onto ex-partner stake for now.
Strides has set a sales target of $200-400m for Stelis’s generic injectables business in two to four years as part of its plan to reach $800m in total revenues in four years. Meanwhile, Stelis’s Rh-teriparatide for osteoporosis and sodium hyaluronate for osteoarthritis await Phase III incremental studies in the US.
Abbott is developing an extended release version of vildagliptin in India, adding a new dimension to the market dynamics for the DPP-4 inhibitor, which has seen a key patent expire. Sustained release vildagliptin products from Wockhardt and Synokem also appear to be in the works.