Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Biotech upstart enGene preps first trial for next-gen 'gene pill' tech

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.

India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

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 keeps many irons in the fire, Malaysian plan on schedule

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 PhIIb cancer survival data fail to impress

CytRx released some unimpressive overall survival rates from its Phase IIb study of its aldoxorubicin compared with doxorubicin for soft tissue sarcoma.