Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Pluristem shines in stem cell trial for muscle injury

Israel's Pluristem Therapeutics is back in the spotlight with some positive results for its stem cell therapy in treating patients with a muscle injury, giving the biotech some good news in its up-and-down development path.

Post-reform Roche stumbles as top schizophrenia drug fizzles in PhIII

Roche's attempt to carve out a meaningful market in neurosciences has suffered a serious setback. The pharma giant says that bitopertin (once dubbed RG1678), failed the first two of 6 Phase III studies, raising some serious doubts about a new therapy designed to address common symptoms of schizophrenia.

ArQule rides high on good news for its never-say-die cancer drug

Massachusetts biotech ArQule has gotten word from its data monitoring committee that its Phase III trial of tivantinib is doing fine despite a dosing reduction that once threatened to derail its development, stoking hopes that the company can finally get its liver cancer treatment across the goal line and sending shares up nearly 30%.

GoBalto goes global with expansion into U.K. and Singapore

San Francisco clinical trial software outfit goBalto has made its first big international push, opening outposts in Singapore and the U.K.

AC Immune begins first trial of a tau-targeting Alzheimer's vaccine

The Switzerland-based biotech has raised $22 million from German billionaire Dietmar Hopp and other backers to advance its Alzheimer's vaccine candidate, ACI-35, into clinical trials.

UPDATED: Intercept shares dazzle after early success of PhIIb liver disease drug trial

Shares of Intercept Pharmaceuticals went into overdrive this morning, soaring a remarkable 125% on the surprise news that a Phase IIb clinical study for its lead drug funded largely by the NIH ended early after achieving the primary endpoint.

Sanofi stops short of baring it all with clinical trial transparency pledge

Pharma giant Sanofi is jumping on the clinical trial transparency bandwagon, agreeing to share data with researchers public and private, but the French drugmaker's plan stops short of the sweeping initiatives favored by some of its rivals.

A step ahead of controversial transparency rules, Sanofi commits to open access

Sanofi is starting the New Year with a resolution to join the open-access movement. But it's keeping the vaults firmly closed on any past data--this is one resolution that applies only to future drug approvals.

Ambitious HDL program joins a growing list of high-profile clinical failures

Cerenis CEO Jean-Louis Dasseux was so confident he had found the magic HDL bullet that he told reporters and a group of investors that he would hold off on any pharma deal for CER-001 until he could prove that the drug worked in a key trial. But like other high-profile HDL therapies that came before it, CER-001 failed.

FIT Biotech is set to start a Phase III HIV vaccine trial

If successful the trial--which is due to last two to three years--will culminate in marketing applications to U.S. and European regulators.