Merck KGaA Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of MS

FDA extends Priority Review period of Cladribine Tablets by three months

29-Nov-2010 - Merck KGaA announced that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011. The FDA granted Priority Review status for Cladribine Tablets in July of ...

Basilea and Astellas update isavuconazole phase III trial in consultation with FDA

29-Nov-2010 - Basilea Pharmaceutica Ltd. announced that in consultation with the U.S. Food and Drug Administration (FDA) Basilea and its partner Astellas Pharma Inc. have agreed to use 'all-cause mortality' as the primary endpoint of the phase III clinical study investigating isavuconazole for the treatment of ...

BioInvent announces approval to start Phase II trial for its novel cardiovascular drug BI-204

12-Nov-2010 - BioInvent International AB announced IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased ...

Oxford Biomedica announces US IND approval for novel ocular product in wet AMD

First of four ocular gene therapies partnered with sanofi-aventis approved to enter Phase I/II clinical development

10-Nov-2010 - Oxford BioMedica plc announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the Phase I/II clinical development of RetinoStat®, a novel gene-based treatment for neovascular “wet” age-related macular degeneration (AMD). RetinoStat® ...

Novartis drug Afinitor approved by FDA as first medication for children and adults with a benign brain tumor

Worldwide regulatory submissions underway, including applications filed in the EU and Switzerland

02-Nov-2010 - Novartis announced, that the US Food and Drug Administration (FDA) has approved Afinitor® (everolimus) tablets for patients with subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS), who require therapeutic intervention but are not candidates ...

Symphogen and Swedish Orphan Biovitrum receive U.S. orphan drug designation for Rozrolimupab in ITP

08-Oct-2010 - Symphogen and Swedish Orphan Biovitrum announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to rozrolimupab (Sym001) for the treatment of primary Immune Thrombocytopenia (ITP). ITP is an autoimmune bleeding disorder characterized by abnormally ...

Pharming plans submission Rhucin BLA to US FDA end 2010

26-Aug-2010 - Pharming Group NV announced that it intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin® for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Following pre-BLA ...

FDA grants Orphan Drug Status for to-BBB’s lead product

25-Aug-2010 - to-BBB announced that the Food and Drug Administration (FDA) has granted orphan drug designation for to-BBB’s brain cancer lead product 2B3-101. As a proprietary brain-targeted version of the marketed product Caelyx®/Doxil® (PEG-liposomal doxorubicin), 2B3-101 uses glutathione (GSH) to safely ...

GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta

23-Aug-2010 - GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). A priority review designation is granted to ...

YM BioSciences granted Orphan Drug Designation for CYT387

JAK1/2 inhibitor currently in Phase II clinical study in myelofibrosis

12-Aug-2010 - YM BioSciences Inc. announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical ...