SINGAPORE – The growth of drug markets in Asia should spur biotech and pharma to rethink clinical trial programs and factor in regulatory requirements of countries including India, China and Korea, from the earliest stages of development. Read More
Amylin Pharmaceuticals Inc., of San Diego, Alkermes Inc., of Waltham, Mass., and Eli Lilly and Co., of Indianapolis, said the European Commission approved Bydureon (exenatide), a once-weekly version of GLP-1 receptor agonist Byetta, for Type II diabetes in adults in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione. Read More
NanoBio Corp., of Ann Arbor, Mich., started a second tolerability and immunogenicity study designed to test and further optimize its nanoemulsion-based intranasal vaccine adjuvant. The Phase Ib study will test the adjuvant combined with Fluzone (Sanofi). Mucosal, systemic humoral and cellular-mediated immune responses will be examined. Read More
In the largest Series B financing of the year – and what appears to be the largest biotech venture financing for any round in 2011 – privately held oncology start-up Tesaro Inc. raised $101 million to advance lead candidate rolapitant, a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting, and a small-molecule inhibitor of anaplastic lymphoma kinase. Read More
German firm Biotest AG is getting $85 million up front in an autoimmune disease deal, with new partner Abbott hoping that the mechanism for midstage candidate BT-061 will be enough to differentiate it in crowded markets such as rheumatoid arthritis (RA) and psoriasis. Read More
