Allergan is urging the FDA to reconsider its generic testing standards for the dry-eye market. The drug maker sent a 43-page complaint explaining that generic competition for its branded Restasis medication should have to test their versions of the treatment in humans. The regulator recently issued draft guidance that would permit competitors to use in in-vitro tests to prove bioequivalence. As FiercePharma notes, this is very similar to the strategy Sanofi (Lovenox), Teva (Copaxone) have used in the hope of prolonging generic development, and therefore extending the sales potential of drugs with a limited patent life. Both Sanofi and Teva failed to change the FDA’s mind.
Phase II trial data indicates that Incyte’s blood cancer drug Jakafi could be a contender in the metastatic pancreatic cancer space. The company reported Wednesday that pairing the JAK inhibitor with chemotherapy increased six-month survival rate by 42% compared with the 11% survival rate among chemo-only patients. The FDA approved the medication for intermediate and high-risk meyelofibrosis patients in 2011.
Medtronic says buying Cardiocom was just the beginning of its plans to turn the medical device company into a cost-savings partner in the health services space. CEO Omar Ishrak tells Bloomberg the strategy puts the company in the healthcare’s center of gravity—the senior population is growing and healthcare reform is bringing more patients into the healthcare system. The company says if it can prove Medtronic’s devices save money, and it has in-house hospital connections, it can gain more patients. It also plays directly into healthcare reform, which is pushing providers to pursue value metrics when deciding on patient care.
Health insurer Aetna’s alliance with iTriage is poised to rein in patient costs. MobiHealth News reports that the insurer is using the iTriage app to help members find in-network providers and even warn users when they are choosing an out-of-bounds (and likely out-of-pocket) professional. Aetna is also using the app to reinforce in-network benefits with notes about how sticking with the plan means lower co-payments.
