SINGAPORE-- Fujifilm's Toyama Chemical is readying a study for a scientific journal stating that its Avigan (favipiravir) influenza drug has shown promise in treating ebolavirus so far in an early-phase clinical trial in the West African country of Guinea.
Phase II data from Genmab have ratcheted up expectations for a fast-track approval of its Johnson & Johnson-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.
Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.
Fast-expanding CRO genae is buying into clinical trial technology, acquiring a company that focuses on electronic data capture.
Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.
India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.
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.