Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Japan green-lights trial of stem cell therapy for eye disease

Japanese researchers have won permission to embark on a pioneering clinical study of a stem cell therapy for age-related macular degeneration, a major cause of vision loss in aging patients. The planned trial is being hailed as the first human test of a stem cell therapy made from patient's own cells.

Novartis buries a PhIII kidney cancer failure behind Q2 successes

Two years ago, investigators for Novartis pulled into ASCO flagging a slate of high-profile cancer drugs at the top of its oncology pipeline, including the mid-stage results for dovitinib (TKI258). Yesterday, if you dug down past its PR on second-quarter successes and into a more detailed description of its pipeline work, you would find that dovitinib failed the head-to-head showdown in Phase III.

Alzheimer's roundup: Investigators carve out small gains against a brutal disease

Alzheimer's was in the spotlight this week as investigators gathered at the annual Alzheimer's Association International Conference in Boston to ponder the latest data available on a field of candidates trying to make some headway against one of the toughest disease targets in the industry. 

NIH confirms it is shelving India drug trials in wake of new regs

Several days after using some flowery language to wave off a question from FierceBiotech regarding the fate of dozens of NIH-sponsored trials in India, the government agency has found its speaking voice.

WuXi, PRA snag ex-Theorem CEO to head China JV

WuXi PharmaTech and PRA believe they have a bright future in China together, and they've picked up the founding CEO of Theorem Clinical Research to lead them there.

Tetraphase's lead antibiotic wins special status at the FDA

Tetraphase Pharmaceuticals has snagged a special federal designation for its lead antibiotic in the clinic, putting the biotech in line for some extra incentives--like an extended period of market exclusivity if it goes on to an approval.

NEA backs Cartiva amid osteoarthritis trial

New Enterprise Associates (NEA) has dipped into its ample coffers to provide Cartiva with $4.3 million. The capital infusion backs the startup's ongoing clinical trial of a cartilage replacement implant in patients with osteoarthritis.

Merck's positive Alzheimer's study spotlights BACE race

Merck's Phase Ib dose-escalating study for MK-8931, a BACE inhibitor for Alzheimer's, has demonstrated a positive effect in reducing the level of toxic proteins flowing through patients, securing Merck's leading position in the BACE-inhibition crowd. 

New rules push drug trials out of India

The last person to complete a drug trial in India should turn the lights out on the way out the door. New reports from the subcontinent indicate that the NIH has slammed the brakes on 40 ongoing studies, part of a rapid slowdown in new drug development work in a country that once figured prominently in the global R&D industry.

NIH, industry back out of India as trials slow to standstill

Amid mounting pressure to rein in loosely regulated trials, India has clamped down on approving studies, but the resulting slowdown has scared off CROs, sponsors and other researchers, according to a report.