Topic:

Clinical Trials

Latest Headlines

Latest Headlines

After failing a PhII/III, Raptor steers Huntington's drug into a pivotal trial

Just three months after pulling the plug on its drug for NASH, Raptor Pharmaceutical says that it's pushing ahead with a pivotal study for a new drug to treat Huntington's, even though it failed the primary endpoint in a Phase II/III trial.

Cara's oral opioid cuts osteoarthritis pain in a Phase II trial

Cara Therapeutics said an oral version of its intravenous painkiller showed promise in a Phase II osteoarthritis study, clearing the way for further trials as the company targets a bevy of approvals.

Allergy Therapeutics brings long-delayed grass allergy vax into PhII

U.K.-based Allergy Therapeutics is finally kicking off Phase II trials of its grass allergy vaccine in the U.S, announcing Monday that it has recruited its first trial participants. The trial will be a double-blind, placebo-controlled cumulative dose selection study.

Second flu shot helps cancer patients stave off infection, Yale team says

A team from the Yale Cancer Center has devised a novel dosing schedule for flu vaccines aimed at increasing protection for cancer patients who are at a higher risk of contracting the viral infection.

Novavax takes RSV vaccine into Phase III ahead of schedule

Novavax has been on a roll with its RSV (respiratory syncytial virus) vaccine lately, landing an $89 million Gates Foundation grant, reporting promising Phase II results in infants and launching a Phase III trial in older adults. Now, the Gaithersburg, MD-based biotech is starting a second Phase III trial in pregnant women to gauge the vaccine's efficacy in infants through maternal immunization.

Analyst: Dynavax hep B vaccine positioned to grab market share from GSK's Engerix-B

Initially approved by the FDA in 1989, GlaxoSmithKline's Engerix-B has been the standard-of-care against hepatitis B. But an analyst thinks Dynavax's experimental Heplisav is poised to swipe some market share once it's approved.

NIAID to bring Chikungunya vaccine into Phase II

No specific treatment or vaccine currently exists for the mosquito-borne Chikungunya virus, but efforts are underway to remedy that. The NIH's National Institute of Allergy and Infectious Diseases (NIAID) will bring its experimental vaccine into Phase II, keeping up with Austria's Themis, which raised $7.9 million to do the same for its candidate last May.

UPDATED: Zafgen shares crash after second patient in pivotal obesity study dies

Six weeks after Zafgen finally broke an uncomfortable silence and acknowledged that a patient taking its experimental obesity drug beloranib had died, the company is reporting that a second patient has died--this time from bilateral pulmonary emboli.

ProQR tanks after slow enrollment pushes back readout from cystic fibrosis trial

ProQR Therapeutics has pushed back the date on which it expects to deliver data from its cystic fibrosis clinical trials. The delay means it may be late 2016 before ProQR presents data on its challenger to Vertex Pharmaceuticals' grip on the cystic fibrosis market.

XBiotech flubs a Phase III trial with its lead cancer drug

Texas upstart XBiotech made a string of embarrassing mistakes in a Phase III trial on its lead cancer therapy, misdosing some patients and failing to adequately test others on the way to a staggering mishap.
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