The newly public Vitae reported after the market closed on Thursday that the oral BI1181181/VTP-37948 hit the goal posts on a key biomarker for BACE, or beta secretase, flushing a prime suspect behind the disease without triggering any red safety flags in a pair of Phase I studies among a small group of healthy volunteers.
Just days after an FDA advisory group gave its unanimous blessing to Novartis for secukinumab (AIN457) as a new treatment for plaque psoriasis, the pharma giant has produced a new slate of Phase III data backing the IL-17 therapy for ankylosing spondylitis.
Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.
India's rotavirus vaccines market is headed for a shake-up, and Sanofi's angling to get in on the action. It got one step closer this week, with its Indian affiliate commencing Phase III clinical trials for its own investigational vaccine.
Investigators working on Novartis' personalized CTL019 CAR-T program at the University of Pennsylvania say that 90% of a small group of children suffering from very advanced cases of treatment-resistant acute lymphoblastic leukemia achieved complete remission after being treated in the newly updated trial.
Last spring a prominent analyst suggested that a successful late-stage study for Smith & Nephew's spray-on cell therapy for wound healing could be a catalyst to break up the company a la Abbott and Baxter. But today, the discussion of the much buzzed-about trigger event turned bitter after the company reported that the Phase III trial flopped.
After acknowledging a midstage setback for its key respiratory drug benralizumab in COPD last month, AstraZeneca's big MedImmune division has come back with positive, though somewhat mixed, Phase IIb data underscoring the effectiveness of knocking down eosinophils--white blood cells--in preventing asthma attacks.
As it works to refine its vaccine strategy for the event of an avian flu pandemic, the NIH is trialing Sanofi's H7N9 vaccine at a range of doses and with a variety of adjuvant combinations. And now, it has one that looks promising.
Hoping to boost its chances of FDA approval early next year, Pfizer has unveiled results from a Phase II clinical trial for its meningitis B vaccine, showing that the jab is safe and effective in adolescents when given alongside a licensed vaccine for human papillomavirus.
When Australian biotech Admedus announced Phase I results for its herpes simplex virus vaccine last week, it was far from the first company to do so. A whole new generation of vaccinemakers are trying their hand in a race that's heating up.