Expanded results from Sanofi's Latin American Phase III dengue vaccine trial are here, and the pharma giant says they confirm the high efficacy against severe dengue and the reduction in hospitalization the jab posted in its first Phase III study. And with these in tow, the company says it could have the vaccine to market by the second half of next year.
Next-generation hepatitis C drugs may be breaking revenue records now, but eventually a vaccine to prevent the disease could cut into the cash cows' market share. That candidate might come from GlaxoSmithKline, whose hepatitis C vaccine just passed an early test, generating strong and broad immune responses not seen before against the transmissible liver disease.
Nymox Pharmaceutical is headed for a bruising opening this morning after putting out word on Sunday that both their late-stage studies of their lead drug flopped as a treatment for enlarged prostate. Partnered with Italy's Recordati, the biotech put out a brief statement blaming the failure on an unexpectedly high placebo response.
Bristol-Myers Squibb's closely watched checkpoint inhibitor nivolumab managed to wow analysts this morning with impressive survival results in a Phase II study of patients with advanced squamous cell non-small cell lung cancer. Of all the patients in the drug arm, 41% were alive at the one-year mark, while investigators tracked an overall response rate of 15%.
Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.
San Diego-based Receptos is on a roll. After the markets closed on Monday, the biotech spread the word that its mid-stage trial for lead drug RCP1063 hit its primary endpoint for spurring remissions and clinical responses among patients suffering from ulcerative colitis in the trial. And the results quickly spurred a 37% spike in its share price, which follows a similar surge when the same drug hit its marks in a mid-stage trial for multiple sclerosis back in the summer.
Procter & Gamble spinoff Akebia Therapeutics rolled out a batch of promising Phase IIb efficacy data for its experimental anemia drug today, but investors who came in early this year to back the biotech's IPO in the belief that it holds the key to a potential blockbuster were dinged with signs of safety issues.
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.