Amicus Therapeutics Inc., of Cranbury, N.J., said its investigational new drug application, submitted to the FDA, is now effective, which allows the firm to begin site initiation and enrollment of a phase I/II study of ATB200 in patients with Pompe disease. Read More
Huya Bioscience International LLC, of San Diego, said the Japanese Ministry of Health, Labour and Welfare designated HBI-8000 an orphan drug in Japan for peripheral T-cell lymphoma. HBI-8000, a class I-selective oral histone deacetylase inhibitor, is completing a phase I open-label, dose-escalation trial in Japan, evaluating the drug's safety and pharmacokinetics in Japanese patients with non-Hodgkin lymphoma. Read More
Sunesis Pharmaceuticals Inc., of South San Francisco, said it closed underwritten offerings of 10.99 million shares of its common stock, which included the exercise of the underwriter's overallotment option of 1.43 million shares, at 84 cents per share, and 20,200 shares of its nonvoting series B convertible preferred stock at $840 each. The company received combined gross proceeds of about $26.2 million from those offerings. Read More
SINGAPORE – Getting East to meet West in drug approval guidelines might make more headway if regulators in Asia looked harder for adaptive licensing prospects, an idea that caught the attention of policymakers in Singapore in 2010, but has since fallen to the wayside regionally. Read More
SHANGHAI – Hutchison Medipharma Ltd., of Shanghai, one of China's biotech pioneers with a deep pipeline of small-molecule oncology and autoimmune candidates, has started dosing Chinese patients with neuroendocrine tumors (NETs) in a phase III trial of sulfatinib. Read More
Local vaccination with a nanoparticle generated a systemic immune response to tumors that subsequently fought metastases elsewhere in the body, researchers reported in the Dec. 21, 2015, online issue of Nature Nanotechnology. Read More
Concerned about the FDA's ability to keep up with the oversight demands of the global drug supply chain, the House Energy and Commerce Committee wants an updated government report card on how the agency is doing, especially in China and India. Read More
Shares of Psivida Corp., of Watertown, Mass., (NASDAQ:PSDV) shot up to a five-year high on above-average trading volume Tuesday after the company reported positive top-line results from its first phase III trial evaluating Medidur to treat chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis). Read More
Two years after entering a crowded field seeking to control gene expression in treating cancer, Effector Therapeutics Inc. showed that its approach – the development of small-molecule translation regulators – has staying power by landing a $40 million series B to advance its first two programs into the clinic. Read More
Christmas came early for Actelion Ltd., as the FDA approved its pulmonary arterial hypertension (PAH) treatment Uptravi (selexipag), putting the company on track to launch the oral prostacyclin receptor agonist early next month for use in delaying PAH progression and patients' risk of hospitalization for symptoms related to the condition. The therapy will be marketed by San Francisco-based Actelion Pharmaceuticals US Inc. Read More
