Seaside Therapeutics missed the main target of a midstage trial of its lead drug STX209 in patients with autism spectrum disorder (ASD), yet benefits of treatment observed in the Phase IIb study have driven the company to plan another major clinical trial in patients with the intellectual disorder.
New research suggests that two doses of human papillomavirus vaccine could be as effective as the current three-dose regimen, which would increase uptake.
A massive, international study to find and evaluate potential Parkinson's disease biomarkers has finished enrolling a first group of 600 Parkinson's patients and controls.
San Diego-based Celladon has made a big splash in the U.K. British scientists are playing a prominent role in a pair of clinical trials of Celladon's Mydicar, a gene therapy for heart failure which uses a benign virus to insert the Serca2a gene into heart cells.
Up until now, the FDA has reserved its new "breakthrough" designation for a Who's Who in drug development, with high-profile companies like J&J, Merck and Novartis touting their scores at the agency. But now the FDA has delivered the coveted designation to Durham, NC-based ScioDerm, a little-known start-up that just landed its Series A of $16 million. And its success is blazing a path others can follow.
Regulators at the FDA have weighed the data for Aveo's tivozanib, raising a simple question that could prove vexing for the biotech: Should another clinical trial be required before the agency delivers its verdict on the cancer drug, given that alternative treatments are available?
When Gilead Sciences' ($GLD) Truvada was approved as an HIV preventative last year, it was hailed as a historic event. It was the first time an HIV drug had been approved to stave off HIV infection, rather than treat those who had already contracted the virus.
In a novel deal, U.K. CRO Ergomed has hitched up with Cel-Sci for a Phase III trial of its head and neck cancer drug, but instead of just handling the study, Ergomed is putting up $30 million to fund development in exchange for single-digit royalties from the treatment.
Jockeying for a leading position in the high-stakes race to develop a new generation of blockbuster diabetes drugs, Merck is hitching a ride with Pfizer's late-stage SGLT2 candidate, ertugliflozin (PF-04971729).
Verastem's quest to develop drugs that block cell signaling pathways that cancer stem cells need to survive hits a major milestone in mid-2013, when it launches a 350-patient clinical trial of a potential companion biomarker test for its investigative mesothelioma drug treatment.