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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
A New York federal judge has tossed out a lawsuit alleging Eli Lilly misled the public over withdrawal symptoms linked to its antidepressant Cymbalta. Read More
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, will now have a centralized place to bring their ideas for advice as the agency replaces its fragmented approach to considering such concepts with a new streamlined system. 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
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. 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
The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits. Read More
The FDA has approved Eli Lilly’s Cyramza in combination with paclitaxel for advanced stomach cancer after chemotherapy, following an approval this spring as a single therapy for treating the disease. Read More