Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Fujifilm's Toyama unit set to publish promising early clinical results in treating Ebola

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.

UPDATED: Genmab stock jumps after PhII cancer data raise hopes of speedy approval

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 clears PhIII hurdle in crowded biosimilar race to topple Humira

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.

Belgian CRO genae buys an eClinical outfit

Fast-expanding CRO genae is buying into clinical trial technology, acquiring a company that focuses on electronic data capture.

Intercept Pharma soars after nabbing 'breakthrough' title for blockbuster NASH contender

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 tweaks presubmission rules on drugs, trials, devices and other regulated products

India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.

Samsung Bioepis advances its Enbrel biosimilar to an EMA review

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.

First batch of GSK/NIH Ebola candidate shipped for Phase III trial in Liberia

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.

The Special K connection: Naurex spotlights another promising NMDA depression drug

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.

Serum Institute of India poses challenge to Merck HPV vaccine

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.