The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
GlaxoSmithKline's Ebola candidate will be the first of several experimental vaccines to undergo large-scale clinical trials. On Friday, the company shipped an initial batch of 300 vials of the vaccine, ChAd3, to Liberia, one of the main countries affected by Ebola.
Just a few months after heralding some strong data for their lead depression drug, Naurex has wrapped a Phase II study of its number two NMDA treatment after getting the positive efficacy data it was looking for--while continuing to set the stage for a possible IPO in its near future.
The Serum Institute of India, the world's fifth largest vaccinemaker by volume, is eyeing newer vaccines, including one for the human papillomavirus expected to be launched by late 2018 and sell at a third of the price of Merck & Co.'s blockbuster Gardasil, Bloomberg reported.
Montreal-based enGene has lined up $11.5 million in venture financing to put its next-gen approach to an inflammatory bowel disease treatment through its first clinical test.
In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.
India's Biocon held a busy earnings call on Jan. 23 that highlighted extensive spending on research and keeping several deals rolling, though tight-lipped on a possible license to make Gilead's chronic hepatitis C products and said it will sell a 10% to 15% stake in its research services arm Syngene through an initial public offering.
CytRx released some unimpressive overall survival rates from its Phase IIb study of its aldoxorubicin compared with doxorubicin for soft tissue sarcoma.
This is a big year for South San Francisco-based Nektar Therapeutics. And the company is making some big expansion plans, telling the local San Francisco Business Times that it has lined up a new lease on extra space as it sets the stage for adding up to 150 staffers.
Fourteen months after the FDA rejected the new antipsychotic cariprazine, the developers say they have gathered together a new batch of late-stage data to demonstrate its effectiveness for schizophrenia, but the statement has done little to dispel the lingering doubts about this one-time blockbuster hopeful.