Altus creates VP-clinical development & medical affairs
Altus Pharmaceuticals appoints Alan Kimura VP-clinical development and medical affairs. The newly created will support Phase II development of the enzyme replacement therapy TheraCLEC (lipase, amylase and protease enzymes) and the long-acting human growth hormone, ALTU-238. Altus expects both products to enter Phase III next year. Since 2001, Kimura served as Transkaryotic Therapies' exec director of clinical affairs...
You may also be interested in...
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.