Monday, April 11, 2016
Eli Lilly and AstraZeneca have announced that AMARANTH, a phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue to phase III of the phase II/III seamless trial.
FDA’s postmarket oversight of expedited drugs found lacking
Royal Philips has announced that a combined total of more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using Philips Volcano’s proprietary iFR (instant wave-Free Ratio) pressure measurement technology versus conventional FFR (Fractional Flow Reserve) measurements.
Newron Pharmaceuticals, an Italy-based biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, has presented results for Evenamide (NW-3509), a putative antipsychotic that targets abnormal electrical activity and glutamatergic abnormalities in improving psychotic symptoms in patients with schizophrenia, in a phase II, placebo-controlled trial.
Genocea Biosciences, a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive 12 month efficacy data from its phase II dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well-tolerated by patients, with no serious adverse events related to the vaccine in the trial.
Revisiting industry partnerships with the Department of Veterans Affairs
Lexicon Pharmaceuticals has submitted a New Drug Application to the FDA seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.
Facing protocol amendments head-on
Eli Lilly and Incyte have announced that detailed results of RA-BEACON, a pivotal phase III global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA), now published in the New England Journal of Medicine.