Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said Takeda Development Center Shanghai and Takeda Development Center Asia Pte. Ltd., started the Phase III TOURMALINE-MM1 global study with the oral proteasome inhibitor, ixazomib, in relapsed and/or refractory multiple myeloma. Read More
Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug status to amituximab, discovered and developed by Morphotek Inc., of Exton, Pa., a wholly owned subsidiary of Eisai, for malignant mesothelioma. Read More
Evoke Pharma Inc., of San Diego, said Phase IIb data published in Neurogastroenterology & Motility showed that intranasal delivery of metoclopramide was more effective in managing symptoms of diabetic gastroparesis compared to the marketed oral tablet formulation of metoclopramide. Read More
Idera Pharmaceuticals Inc., of Cambridge, Mass., reported publication of a study supporting the potential role of the suppression of Toll-like receptors (TLRs) 7, 8 and 9 to treat psoriasis in PLOS One. Read More
Ico Therapeutics Inc., of Vancouver, British Columbia, said it priced its previously announced overnight marketed offering of equity securities and will issue an aggregate of up to 16,206,483 units at C$0.4165 each for aggregate gross proceeds of approximately C$6.75 million (US$6.1 million). Read More
LONDON – A better understanding of the metabolic pathways affected by mitochondrial defects linked to Parkinson’s disease could lead to new ways of preventing further deterioration in people diagnosed with this condition. The findings may even provide new targets for potential anticancer treatments, as some of the same pathways are also essential in rapidly dividing cancer cells. Read More
The delayed PDUFA date and lack of labeling talks with the FDA presaged unhappy news for Amag Pharmaceuticals Inc. regarding its supplemental new drug application (sNDA) for intravenous Feraheme (ferumoxytol), and a complete response letter (CRL) came next. Read More
Running two large-scale Phase III programs seems a daunting prospect for a privately held biotech to undertake on its own, particularly in neurodegenerative and neuropsychiatric disorders, areas that have felled big-name contenders over the past several years. Read More
LONDON – Piqur Therapeutics AG closed its Series A funding, providing the means to start a Phase I study of its lead next-generation dual kinase inhibitor program in cancer, and enabling the company to expand the scope of its technology into other indications. Read More
The Supreme Court shot down the Federal Circuit’s attempt to shift the burden of proof from patent holders to licensees when they seek a declaratory judgment in some patent disputes. Read More
