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The FDA wants to know how differing levels of exposure to a drug advertisement affect a person’s perception of a product’s risks and benefits. Read More
Belgian pharma giant UCB is divesting its U.S.-based specialty generics subsidiary Kremers Urban Pharmaceuticals in a $1.525 billion sale to a pair of private equity firms. Read More
German drug cost regulators have rejected Eisai’s latest request for brand level pricing on its anti-epileptic drug Fycompa, marking the second time the drug has failed to win the higher reimbursement level. Read More
A federal judge has dismissed claims brought by a group of pharmacies that Pfizer and Ranbaxy forged an illegal deal to delay generic competition to Pfizer’s cholesterol drug Lipitor, marking another victory for the manufacturers in the class action filing. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral. Read More
Manufacturers don’t appear to be waiting for FDA guidance to meet a Jan. 1 deadline of the new track-and-trace law, and instead have begun implementing an electronic version of a widely used tracking form to satisfy the law’s requirements. Read More
Mylan said yesterday it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated average of $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More