INC Research has started what it says is the industry's first site advocacy group, gathering study investigators to discuss how to improve speed and results in R&D.
Researchers have developed a soft, conductive electronic polymer mesh that can be injected into the brain to monitor and stimulate it at the level of individual neurons. They have published preclinical data on the device in the latest issue of Nature Nanotechnology.
Germany's Biotronik touted a recent study of its CE-marked Pulsar-18 stent for peripheral artery disease, saying the data showed the device can be used in challenging cases of the condition.
Novartis has the first next-gen psoriasis med on the market in Cosentyx, and it's been spending money to take that first-to-market advantage as far as it can. But the Swiss drugmaker wants the treatment to be first in other indications, too. On that front, it got a boost on Wednesday with some new results in ankylosing spondylitis.
Getting innovative medical devices that fill a critical patient need to the U.S. market faster is a stated goal of the Food and Drug Administration. To that end, it recently finalized its Expedited Access Pathway (EAP) in an April guidance. Cohera Medical is among the first to tread this path; it has received an EAP designation and priority processing status for its Sylys resorbable synthetic sealant for use in gastrointestinal surgical procedures to prevent leakage.
Biogen's recent early-stage success in Alzheimer's disease has galvanized R&D in the field, and Roche, owner of a similar treatment, is considering whether to tee off another Phase III trial for its once-failed antibody.
Researchers from MIT demonstrated that a 3-mm-long microdevice holding up to 16 different drugs and drug combinations can release those drugs when implanted directly in a tumor to then determine the tumor's sensitivity to those therapies.
Braeburn Pharmaceuticals is confident about FDA approval of its Probuphine subdermal implant to treat opioid addiction after its pivotal trial demonstrated it worked at least as well as sublingually administered buprenorphine/naloxone. But an unexpected rejection of the candidate by the FDA in 2013 means the outcome is far from certain.
For some time after the FDA put its new breakthrough therapy designation together for the industry, there was a good deal of back and forth among industry analysts over whether the BTD would make much of a difference. You don't hear much of that kind of carping much these days, and a new report from EP Vantage illustrates why.
Intarcia expects to report Phase III data during the second half of 2015 for the remaining two of its four pivotal trials in its program for once-yearly exenatide implant ITCA 650. If all goes well, it plans to head to the FDA next year. This week, the company offered detailed results at the American Diabetes Association (ADA) conference in Boston from June 5-8 for its two Phase III trials that had already reported data in October 2014.