Topic:
Clinical Trials
Latest Headlines
Latest Headlines
International Parkinson's biomarkers trial begins
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.
Celladon's gene therapy for heart failure takes spotlight in the U.K.
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.
Biotech upstart joins Big Pharma cast on high-profile 'breakthrough' stage
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 $16 million. And its success is blazing a path others can follow.
UPDATED: Aveo shares plunge after FDA review raises fears of tivozanib rejection
Regulators at the FDA have weighed the data for Aveo's tivozanib, raising a simple question that could prove vexing for the biotech: Should another clinical trial be required before the agency delivers its verdict on the cancer drug, given that alternative treatments are available?
Search goes on for HIV vaccine after NIH trial nixed
When Gilead Sciences' ($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.
Ergomed signs up to share costs, profits of Cel-Sci drug
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.
Rival giants team on diabetes as Merck partners with Pfizer on SGLT2 combo
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 gears up for companion Dx mesothelioma treatment trial
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.
MedImmune chief taps top prospects, hunts new biologics deals
Last year AstraZeneca's MedImmune did about 20 biologics deals, not counting the academic pacts it assembled. Bahija Jallal, head of R&D, tells FierceBiotech there will be no letup in talent scouting: "If we do as little or more than last year, I would be happy."
Shunned Gilead/Bristol-Myers hep C combo may be too good for docs to ignore
Rival drug combination works to perfection for toughest hep C patient group, and some patients and doctors appear willing to consider taking matters into their own hands.
