Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

As PhIII data looms, Nektar sets the stage for a big expansion

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.

Actavis, Richter tout new PhIII data for their tarnished schizophrenia drug

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.

Singapore to detail trial of MicroVAX novel cancer vaccine

The National Cancer Centre Singapore will brief on the status of a first-in-human clinical trial using an adenovirus under a protocol endorsed by the U.S. Food and Drug Administration and Singapore's Health Sciences Authority, highlighting the wealthy city-state's push to be a leader in early stage clinical trials in Asia.

Arrowhead tanks after FDA reins in dosage on key hep B trial

Shares of Arrowhead Research took a beating Monday morning after the biotech revealed that the FDA had made a preliminary call on a partial clinical hold on a Phase IIb trial of its lead drug for hepatitis B.

Late-stage trials for Glaxo, Merck Ebola jabs could begin this month in West Africa

GlaxoSmithKline and tandem Merck and NewLink may have only recently ramped up development efforts for their Ebola vaccine candidates, but late-stage trials of the jabs in the affected countries are already on the horizon, the World Health Organization says.

Infinity scraps an arthritis program after lead drug fails PhII

Shares of Infinity Pharmaceuticals took a hit this morning after the company conceded that its mid-stage effort to advance its lead drug duvelisib for rheumatoid arthritis flopped on all three doses that were tried out. Infinity says that it will now scrub the RA program and stay focused on its late-stage deal with AbbVie to move duvelisib through the clinic for blood cancers.