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 readies for FDA in 2016 as it reports detailed Phase III data for once-yearly diabetes implant
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.
Novo Nordisk's next big thing in diabetes beat out the world's top-selling insulin in a late-stage trial, stoking blockbuster hopes for the combination treatment. But a previous regulatory setback will keep the cocktail off of U.S. shelves until next year at the earliest.
Australia's Regeneus has won regulatory approval to test a cancer therapy that it first pioneered for use in dogs with cancer. It's a personalized cancer vaccine created from each patient's tumor cells, which are combined with a medicine that's designed to activate the immune system.
Medtronic aims for diabetic consumer tech in deals with Samsung, Glooko and connected MiniMed clearance
Medtronic disclosed a trio of initiatives to make diabetic monitoring and management easier. These reflect the company's broader, ongoing commitment to transitioning into a focus on diabetic consumer wellness and include partnerships with consumer electronics company Samsung, diabetes data startup Glooko and an FDA clearance for MiniMed Connect.
After being in business for 18 years and growing its headcount toward 700, Saama Technologies has decided now is the time to do a Series A round. The analytics specialist has raised $35 million from Carrick Capital Partners to bankroll development of industry-specific tools for life sciences and other sectors.
With its cystic fibrosis combo drug awaiting a likely approval at the FDA, Vertex is beefing up its pipeline in the field, paying $80 million upfront and promising up to $1.1 billion more in milestones to partner with Parion Sciences on a new class of CF-related drugs.
NuCana is set to start a Phase III trial of Acelarin in patients with pancreatic cancerthis month, kicking off a surge into late-stage studies that will see it work on ovarian and biliary programs later this year. The Sofinnova Ventures-backed biotech is initiating the multi-front advance on the strength of Phase I/II data, details of which were presented at ASCO.