DUBLIN – To no one's great surprise, UCB SA and Amgen Inc. confirmed Monday that they had received a complete response letter from the FDA for their BLA for Evenity (romosozumab), which is in development for osteoporosis in postmenopausal women.
Clarus Ventures, which has been shifting iteratively from traditional venture investing to structured financings, completed its transformation with the close of Clarus IV LP, which topped its $750 million goal by attracting $910 million in assets. The size of the fund pushed the firm, which has offices in Cambridge, Mass., and South San Francisco, beyond $2.6 billion in assets invested across 50 private and public life sciences companies.
Cancer Prevention Pharmaceuticals Inc., of Tucson, Ariz., said it launched a phase II trial at Vanderbilt University Medical Center to test CPP-1X in patients with precancerous gastric lesions who are at high risk for gastric cancer.
Valeant Pharmaceuticals International Inc., of Laval, Quebec, said certain affiliates of the company entered an agreement to sell its Obagi Medical Products skincare business for $190 million in cash to Haitong International Zhonghua Finance Acquisition Fund I LP.
Cymabay Therapeutics Inc. said positive interim phase II results for its primary biliary cholangitis (PBC) treatment, seladelpar, won FDA support for extended dosing of the drug, a key go-ahead enabling the company to plan its phase III program. Data on two low doses of the drug suggest it can drive down serum levels of alkaline phosphatase (ALP), a biomarker correlated with reduced need for liver transplant and risk of death, while avoiding elevation of another biomarker, transaminase, that is tied to severe liver damage and was raised in a few cases during tests of higher doses.
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