Topic:

Clinical Trials

Latest Headlines

Latest Headlines

U.K. academics move cell-gene lung cancer therapy into clinic

A team of London-based academics is set to trial a stem cell-delivered gene therapy in patients with lung cancer. The 56-person trial is the first time a stem cell-gene therapy combination has been tested in humans in the U.K.

Eyeing an FDA filing, Ocular Therapeutix drug hits PhIIIa goals

Ocular Therapeutix says that its lead eye therapy successfully wrapped the first of two Phase III studies, reducing inflammation and pain among a group of patients after cataract surgery. And with the second late-stage trial due to report out in a matter of weeks, the biotech says it remains on track to file for an approval in Q2.

Baxter and its controversial partner CTI claim a win in PhIII blood cancer study

Baxter and CTI BioPharma say they have come up with statistically significant topline data on the effectiveness and safety of pacritinib, their late-stage therapy for myelofibrosis. But after the biotech's many twists and turns taken trying to advance pixantrone over the years, a few longtime observers preferred to wait and see the actual numbers before deciding for themselves.

J&J, Merck to advance Ebola vaccines in Africa, but their fate rests in WHO's hands

Johnson & Johnson is ready to start trialing its Ebola vaccine in Africa, where Merck and NewLink are preparing to take theirs into Phase III. GlaxoSmithKline is also testing its jab there. But while thousands of healthcare workers have volunteered to participate in Ebola vaccine trials, the decision to mass-vaccinate against the disease is still up in the air.

Aduro, BMS cancer vaccine combo to start Phase II

In another step forward for cancer vaccine combos, Aduro Biotech announced Thursday that an investigator-led Phase II trial of its GVAX and CRS-207 for pancreatic cancer with Opdivo, Bristol-Myers Squibb's PD-1 drug, would begin.

Amgen hands off an IL-15 drug--strings attached--for upstart effort on celiac disease

A week after first raising the flag on their newborn biotech, a pair of entrepreneurs unhatched a deal today to take down a drug program that has been gathering dust on Amgen's R&D shelves for the past 7 years and test it as a new treatment for celiac disease.

Valeant touts PhII Provenge data following Dendreon buy

Valeant only just picked up Provenge and other assets from bankrupt Dendreon, but it's already trumpeting positive preliminary data for the flailing cancer vaccine. On Wednesday, it announced Phase II results showing that the immune response from Provenge continues two years after biochemically recurrent prostate cancer patients complete treatment.

Amgen completes PhIII trifecta as AMG416 goes head-to-head with Sensipar

Amgen hit the trifecta with a successful conclusion to its third, and last, Phase III study of AMG416, a new drug for secondary hyperparathyroidism which handily beat out its in-house rival Sensipar in a head-to-head study.

Department of Defense gives contractor $14.8M to test so-called Sample-to-Sequence system

The Department of Defense has a habit of funding new medical technologies. This week it awarded a government contractor MRIGlobal $14.8 million for its proposed Sample-to-Sequence system to sequence the entire genome of pathogens and give a diagnosis within 24 hours.

Exclusive: Regeneron, Sanofi outline promising PhIIb data for top blockbuster pick dupilumab

Regeneron and its close partner Sanofi have posted another set of promising results for dupilumab--which targets the interleukin-4 and interleukin-13 inflammatory proteins--from a Phase IIb study that backs up those high expectations.