Roche says its closely watched PD-L1 checkpoint inhibitor atezolizumab (MPDL3280A) hit its primary endpoint in a midstage study for bladder cancer, shrinking tumors for a narrowly defined set of patients and setting the stage for early discussions with the FDA about the possibility of an accelerated approval for this "breakthrough" drug.
J&J's IL-23 blocker came through in a Phase IIb psoriasis study, with one of the top doses clearing symptoms of the disease in 86% of patients. Easily beating out the placebo response, the top psoriasis contender--which is facing off against a lineup of competing remedies in late-stage development--also beat out Humira in the study.
The mosquito-borne West Nile virus has infected more than 41,000 people and killed more than 1,700 people in the U.S. since 1999. But while there is an effective veterinary vaccine for the virus, there is no commercially available human vaccine. The National Institutes of Health's NIAID is launching a Phase I trial of a human vaccine at Duke University.
The search for an HIV vaccine has been long and difficult, but researchers from Johnson & Johnson, Harvard and other groups may have made a leap. J&J's Janssen reported encouraging results Thursday from its preclinical trial of an HIV vaccine in rhesus monkeys. Encouraging enough for the company to sponsor human studies--the first time a Big Pharma is doing so in the HIV space.
Imperial Innovations is negotiating with pharma companies over its gene therapy that has shown the potential to treat cystic fibrosis. A trial of the gene therapy posted patchy but promising data this week, putting the tech-transfer business in a position to strike a deal for further development.
Roche heralded the late-stage success of two big trials for its multiple sclerosis drug ocrelizumab today, which they say puts them on a straight road to regulatory filings for the injectable in early 2016. But even under the best-case scenario for the future, the Big Pharma player will face a tough task squaring off against the new oral drugs that have been divvying up this big market recently.
DBV Technologies has exited its end-of-Phase II meeting with FDA with a plan for the next steps of development of its peanut allergy vaccine. And with Aimmune Therapeutics breathing down its neck, the French biotech is keen to get its pivotal trial up and running before the end of the year.
Baxalta won't formally debut as an independent Baxter drug spinoff for a few more days, but the company isn't waiting to discuss an early peek at efficacy results from a Phase I/II study of their long-term gene therapy for hemophilia.
A couple of years ago, as Vical struggled to overcome a Phase III flop for its cancer vaccine, the biotech said it would hustle ahead with a Phase I/II study of a herpes vaccine as part of its strategy to calm jittery investors. But after the markets closed Monday, the San Diego-based company was forced to concede that their herpes strategy had misfired as well, with their vaccine failing to perform as well as a placebo.
Portola Pharmaceuticals has laid out the last batch of Phase III data on its "breakthrough" anti-anticoagulant andexanet alfa, filling in the numbers that will be reviewed by regulators considering the biotech's upcoming pitch for marketing approval. And right alongside that announcement comes the latest numbers from Boehringer Ingelheim's breakthrough program for idarucizumab, which is already under review as an antidote to its blockbuster Pradaxa.