Amgen's cancer vaccine candidate may be awaiting FDA and EMA approval as a melanoma monotherapy, but like many of its peers, it's also looking to explore its prospect's potential as part of an immunotherapy duo, and now it's kicked off a trial combining its treatment with Merck's anti-PD-1 therapy that should help it do just that.
Right now, there is no FDA-approved cholera vaccine for U.S. travelers heading to high-risk countries. A California company hopes to change that soon: On Monday, PaxVax said it planned to submit a Biologics License Application for its oral single-dose candidate in mid-2015.
Circassia Pharmaceuticals' pipeline has suffered its first notable post-IPO setback. The British biotech's ragweed allergy drug failed to live up to expectations in a Phase IIb trial, prompting the company to dig deeper into the data in search of a path forward for the candidate.
Just days after GlaxoSmithKline and the NIH's National Instite of Allergy and Infectious Diseases announced Phase I success for their investigative Ebola vaccine, Merck and NewLink Genetics have their own positive news to report.
The race for an Ebola vaccine is ramping up with positive Phase I data from an experimental vaccine made by GlaxoSmithKline and the NIH's National Institute of Allergy and Infectious Diseases. And thanks to those results, larger trials could be on the way soon.
Eli Lilly's never-say-die strategy for Alzheimer's has inspired another high-risk campaign in the clinic. The shrinking pharma giant--about to be bumped from the top 10 by a growing Actavis--has launched its pivotal Phase II/III study of its BACE drug for Alzheimer's, newly partnered with AstraZeneca.
Amgen and AstraZeneca have racked up their third straight Phase III win for brodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.
The Department of Health and Human Services and the National Institutes of Health are proposing new rules that would greatly expand the number of clinical trials required to publicize their results, a move that could change how CROs handle data.
Medidata and partner TransCelerate BioPharma, a nonprofit run by the world's largest drugmakers, are amplifying their call for clinical trial runners to embrace new technology, unveiling study results that support the adoption of risk-based monitoring.
Themis Bioscience and the Institut Pasteur have good news to report from a Phase I trial of their Chikungunya fever vaccine candidate. And the pair thinks its successful results just might lead to advances in other diseases, too.