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Federal prosecutors indicated Thursday they view Physician Payment Sunshine Act reports as a potential source of data to build new False Claims Act investigations. Read More
Drugmakers’ validation activities should be clearly defined in a validation master plan (VMP) that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
Gilead is yielding to pressure to reduce the price of its game-changing hepatitis C drug Sovaldi just weeks after it hit the U.S. market, developing an access program as well as licensing partnerships with generic drugmakers in India to manufacture cheaper versions of the drug for the Indian market. Read More
Days after the FDA said it plans to investigate the safety of testosterone replacement drugs, Abbott was hit with five lawsuits claiming the drugmaker marketed Androgel to millions of men who didn’t need it and hid the risks of heart attack and stroke associated with the drug. Read More
FDA Commissioner Margaret Hamburg took the unusual step Thursday of publicly defending the agency’s expedited drug approval pathways in the face of growing criticisms, which now include a congressional inquiry into the FDA’s approval standards. Read More
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More
Sponsors of new drugs and biologics intended to treat chronic pain should plan on submitting more safety data than they would to support candidates for acute pain, the FDA says. Read More
As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More
Merck & Amgen will collaborate on a Phase Ib/II trial evaluating Merck’s MK-3475 in combination with Amgen’s talimogene laherparepvec anti-cancer immunotherapies. Read More