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). Read More
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. Read More
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. Read More
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. Read More
Shooting for an accelerated approval with priority review, Spectrum Pharmaceuticals Inc. submitted the new drug application (NDA) for belinostat, a pan-histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL), and it expects a response from the FDA within 60 days. Read More
LONDON – The discovery of a gene that is mutated at a very low frequency in a range of cancers could lead to new therapeutic strategies to help treat many different cancers. Read More
Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the FDA granted fast-track designation to Lymphoseek (technetium 99m tilmanocept) injection for sentinel lymph node detection in patients with head and neck cancer. Read More
Cytokinetics Inc., of South San Francisco, presented results of a trial testing CK-2127107 in healthy male volunteers at the International Conference of the Society on Sarcopenia, Cachexia and Wasting Disorders in Kobe, Japan. The compound activates the fast skeletal muscle troponin complex. Read More
Ambit Biosciences Inc., of San Diego, presented data for quizartinib, including results from a Phase IIb study showing that a clinical response rate of 47 percent in subjects with FLT3-ITD-positive relapsed acute myeloid leukemia (AML) receiving lower doses – 30 mg – of drug. Read More
Baxter International Inc., of Deerfield, Ill., said it submitted a biologics license application for the approval of OBI-1, a recombinant antihemophilic porcine sequence Factor VIII, in patients with acquired hemophilia A. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said the data monitoring committee for the Phase II/III EPOCH study testing MK-8931, an oral beta-amyloid precursor protein site-cleaving enzyme, or BACE, inhibitor, in mild to moderate Alzheimer’s disease recently completed its planned interim safety analysis and recommended that the study continue to recruit patients with no changes to protocol. Read More
