|Healthcare Review: Edwards Lifesciences, Allergan, Questcor Pharmaceuticals, Navidea Biopharmaceuticals, Repros Therapeutics|
|By Staff and Wire Reports|
|Wednesday, 21 August 2013 18:29|
Edwards Lifesciences (EW) says Japan has given the go-ahead for reimbursement costs of its transcatheter aortic heart value.The reimbursement is scheduled to go into effect on October 1.The rate has been set at ¥4.53M (approximately $46K) for when the valve used in the treatment of patients with severe symptomatic aortic stenosis, and covers the cost of the device as well as taxes, certain hospital fees and distribution expenses.
Allergan (AGN) is out defending Restasis in the face of FDA draft guidance issued in June which said in vitro analysis would be sufficient to establish bioequivalence.AGN "respectfully" disagrees, calling the regulator's proposal "unsound both scientifically and legally."In short, AGN wants generics tested in patients rather than just in the lab, which would fend-off competition for the drug which generated nearly $800M in revenue in 2012.
Questcor Pharmaceuticals (QCOR) is up 4.9%.Bank of America upgrades the shares to Buy from Neutral.Price target raised to $80 (from $58), representing a 23% upside from Tuesday's close.On Monday, Oppenheimer raised its price target on the shares to $73.
Navidea Biopharmaceuticals (NAVB) signs an agreement for Siemens Petnet Solutions (SI) to manufacture Navidea's NAV4694 PET imaging agent, which is in Phase II and Phase III trials for evaluating patients with signs of Alzheimers disease and mild cognitive impairment.Siemens Petnet Solutions operates the world's largest network of PET (positron emission tomography) radiopharmaceutical drug manufacturing facilities and dispensing nuclear pharmacies.
Repros Therapeutics (RPRX) reports six-month interim results from a study of "Androxal treatment of secondary hypogonadal men and its effect on bone mineral density."No bone loss was observed compared to placebo.Some improvement in bone mineral density was observed in the Androxal group.Topline, 12-month results are due in Q2 2014.