Enanta Pharmaceuticals Inc. reported an impressive 96 percent sustained virologic response after 12 weeks of treatment (SVR12) for hepatitis C virus (HCV) in its Phase III (SAPPHIREII) study of a regimen containing protease inhibitor ABT-450 (ritonavir).
Hailing the investment as one of Europe’s biggest for a preclinical-stage biotech firm, Covagen AG closed a Series B round at CHF42 million (US$47 million) and has provided its investors with an option to extend the round by another CHF14 million.
LONDON – Researchers, pharma and biotech companies, leaders of the World Health Organization and health and science ministers from the G8 countries are meeting in London on Wednesday to set out a global plan of action for dealing with dementia.
Although the U.S. is several years behind Europe in how it treats allergies, it may be about to catch up. The FDA’s Allergenic Products Advisory Committee (APAC) is slated this week to look at the first sublingual allergy tablets to come down the pike in the U.S.
Helsinn Group, of Lugano, Switzerland, and Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for review the submission of the new drug application for the investigational oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg for prevention of acute and delayed chemotherapy-induced nausea and vomiting following highly and moderately emetogenic chemotherapy.
Chelsea Therapeutics International Ltd., of Charlotte, N.C., dosed its first patient in Study 401, a trial of Northera (droxidopa) for neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency, and non-diabetic autonomic neuropathy.
Glycomimetics Inc., of Gaithersburg, Md., said it highlighted its glycomimetic drug candidate, E-selectin antagonist GMI-1271, during an oral presentation and poster session. GMI-1271 is currently in preclinical studies for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis.
Summit Corp. plc, of Oxford, UK, said the first Duchenne Muscular Dystrophy (DMD) patient has been enrolled and dosed in a Phase Ib clinical trial of the oral, small molecule utrophin modulator SMT C1100.
Despite being haunted by the progressive multifocal leukoencephalopathy (PML) specter raised by natalizumab, Takeda Pharmaceutical Co. Ltd.’s Entyvio got strong support Monday from two advisory committees that weren’t overly concerned by trials that missed some endpoints.