Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Karolinska's Axelar comes up short in Phase II with lung cancer drug

Swedish biotech Axelar's lung cancer drug failed to beat out standard docetaxel in a mid-stage trial, but bankroller Karolinska Development isn't giving up, planning to keep studying the drug in hopes of finding a partner.

Tesaro's shares are routed on late-stage cancer drug data

Tesaro touted positive results for the primary endpoints laid out for the late-stage program it had underway for its top cancer drug prospect rolapitant, but investors soured on the drug after it failed to score secondary goals and drove the biotech's shares down by a hefty 22% this morning.

Vertex's Kalydeco flunks a Phase III for cystic fibrosis

Vertex Pharmaceuticals' piecemeal approach to the world's cystic fibrosis sufferers took a hit as Kalydeco failed to meet its primary endpoint in a Phase III trial on patients with one form of the disease, sending the company's shares down as much as 6% premarket on Thursday morning before an eventual rebound.

Gilead races to the FDA with stellar PhIII results for its breakthrough hep C combo

Gilead unveiled a package of stellar late-stage cure rates for its closely-watched hepatitis C combination of the newly approved "nuke" Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, putting it on a short path to the FDA with a new drug application planned for the first quarter of the coming year.

Onconova tanks as its lead candidate flunks PhIII for pancreatic cancer

Onconova Therapeutics' shares took a 16% beating Tuesday night after the company's top prospect, rigosertib, failed a Phase III trial in patients with pancreatic cancer.

Amgen's PCSK9 drug hits PhIII mark in the race for a new cardio blockbuster

Amgen's PCSK9-blocking evolocumab hit its primary endpoints in a Phase III study, the company said, bringing down bad cholesterol and stirring fresh hope for the company as it races with Pfizer, Sanofi and others to cash in with a new approach to cardiovascular treatment.