Drug Trials News for September 2009

Drug Trials News Archive

FDA and EMEA grant orphan drug designation for Antisense Pharma's investigational drug trabedersen in pancreatic carcinoma FDA and EMEA grant orphan drug designation for Antisense Pharma's investigational drug trabedersen in pancreatic carcinoma

Orphan drug designation ensures market exclusivity for seven to ten years after market approval.

Phase III head-to-head trial showed ticagrelor reduced cardiovascular death and heart attacks over clopidogrel in acute coronary syndromes patients Phase III head-to-head trial showed ticagrelor reduced cardiovascular death and heart attacks over clopidogrel in acute coronary syndromes patients

AstraZeneca recently announced results from the Phase III head-to-head trial PLATO that demonstrate that ticagrelor has achieved greater efficacy in the primary endpoint, reduction of cardiovascular events, than clopidogrel.

Shire completes submission of NDA for velaglucerase alfa for Type 1 Gaucher disease and reports positive results for remaining two Phase III trials Shire completes submission of NDA for velaglucerase alfa for Type 1 Gaucher disease and reports positive results for remaining two Phase III trials

Shire reported recently that it has completed its submission of a New Drug Application for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the U.S. Food and Drug Administration.

Ablynx announces positive Phase I results for subcutaneous administration of its anti-thrombotic Nanobody, ALX-0681 Ablynx announces positive Phase I results for subcutaneous administration of its anti-thrombotic Nanobody, ALX-0681

Ablynx recently announced positive results from its Phase I study with ALX-0681, a subcutaneous formulation of its novel anti-thrombotic Nanobody® that selectively targets von Willebrand factor.