Wilex AG expects to file for the registration of its experimental antibody for renal cell carcinoma, girentuximab, in the US and Europe during the first half of 2013. Data from a pivotal trial of the drug are expected in the fourth quarter of this year.
Takeda Pharmaceutical Company Ltd has agreed to pay $800 million upfront, plus future performance-based milestones, for privately-owned URL Pharma Inc. URL has a marketed product for gout that had 2011 net sales of $430 million.
Wilex AG has announced the start of a Phase 1b/2 trial in patients with solid tumours of its experimental drug that inhibits the mitogen-activated protein kinase (MEK). The study will be conducted in the UK.
Aleva Neurotherapeutics SA of Switzerland has raised CHF 4 million (€3.3 million) in a Series B financing round to advance development of its implant technology for deep brain stimulation. The round was led by Banexi Ventures Partners.
Fresh from a private placement that raised €77.8 million, ThromboGenics NV of Belgium is expanding its commercial presence in the US ahead of the expected regulatory approval later this year of its lead product for eye disease, ocriplasmin.
Researchers from the US and Canada have reported generating a new type of cell line, endodermal progenitor cells, which they say could be used as a new tool for modeling human disease including diabetes and liver disease.
A team of experts in advanced therapies has concluded that developers of cell, gene and tissue-engineered therapies may need more support from the regulatory authorities in translating their discoveries into products for possible commercial use.
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.
UCB SA of Belgium and Amgen Inc have launched a Phase 3 trial of their jointly developed monoclonal antibody for the treatment of postmenopausal osteoporosis. The antibody binds to and inhibits sclerostin, a protein secreted by bone cells.
BTG Plc has raised its revenue forecast for the year ended 31 March, in part due to unexpectedly strong sales of the prostate cancer treatment, Zytiga (abiraterone acetate), which is partnered with Johnson & Johnson.