The number of Ebola cases in West Africa has been declining, which has made it more difficult to enroll patients for clinical trials of leading vaccine candidates. And the way GlobalData analyst Daian Cheng sees it, that means it's time for vaccine manufacturers to "weigh the risks and benefits of developing further interventions for a disease that goes through unpredictable cycles of intense outbreaks followed by its virtual disappearance."
San Diego-based Acadia Pharmaceuticals put out word on Wednesday evening that it is delaying its expected NDA for pimavanserin from Q1 back to some time in the second half of this year. And the company says its CEO is out the door.
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.
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 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.
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.
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.
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 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 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.