Pfizer regional president Diem Nguyen said he doesn’t expect the FDA to determine biosimilar interchangeability anytime soon in comments he made at the recent Goldman Sachs Biosimilars Conference. “The FDA has been falling short in terms of how they define interchangeability at this point, but certainly one of those aspects is that [there is not going to be] one decision for all of the biosimilars,” BioPharma-Reporter wrote. Currently an interchangeable biological product may be substituted for a reference product without the intervention of a healthcare provider, according to the Biologics Price Competition and Innovation Act.
AARP launched an initiative—Project Catalyst—that will evaluate health apps and devices used by consumers ages 50 years old and older. The project includes collaborations with Pfizer and UnitedHealthcare. The first study, run by Georgia Tech Research Institute, will test six sleep- and activity-tracking devices over six weeks. The study hopes to evaluate how technology is meeting older users’ needs and where there may be areas of improvement, according to MedCityNews.
Bristol-Myers Squibb entered into a collaboration with Dutch biotech UniQure to develop gene therapies for cardiovascular diseases. The agreement includes UniQure’s congestive heart failure gene platform, which aims to restore the heart’s ability to create S1000A1—a calcium sensor protein that helps to regulate heart function. BMS will pay $50 million upfront per the terms of the deal.
Curis received orphan-drug designation for CUDC-907, its treatment for diffuse large-B cell lymphoma (DLBCL). DLBCL is an aggressive form of non-Hodgkin lymphoma. The drugmaker plans to move to Phase-II trials in the second half of this year. The American Cancer Society estimates that there will be 71,850 new cases of non-Hodgkin lymphoma in the US in 2015.
Pradaxa is vying for its fourth indication as a treatment for the prophylaxis of deep vein thrombosis and pulmonary embolisms in patients who have had hip surgery. Boehringer Ingelheim filed the supplemental New Drug Application for Pradaxa based on two Phase-III trials, which the FDA accepted. Pradaxa was first approved in 2010 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.