Agios Pharmaceuticals was the biotech canary in the coal mine when it went public last year. Not only did it survive its IPO, it thrived, helping lure dozens of other biotechs into the market with solid proof that investors would buy into a drug developer with no human data in the portfolio.
Global CRO Clinipace has agreed to manage clinical trials for Nexstim as the Finnish devicemaker works toward FDA approval for its neurostimulation therapy.
In the first detailed glimpse of palbociclib's impact on overall survival--a key feature to the future prospects of this flagship program--the therapy has failed to demonstrate a statistically significant improvement in extending patients' lives after an initial assessment.
Investigators are halting recruitment for a small study using T cells reengineered with chimeric antigen receptors against CD19-positive B cells for aggressive non-Hodgkin lymphoma, triggering concerns about the potential fallout at Juno Therapeutics, the biotech formed to commercialize the effort.
Amgen's cancer-fighting viral vaccine has been rolling through Phase III, producing a series of positive results. But after missing a secondary endpoint in overall survival, the California-based biotech's hot prospect now has a big blot on its resume.
Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.
Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart pump function compared to the placebo group.
No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.
Parexel is stretching its global network of clinical trial supply operations with a new distribution center in Singapore, bringing the facility online to better support studies across the globe.
J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.