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As of Wednesday night, the Federal Trade Commission (FTC) had received a whopping 24,113 comments in response to its February notice soliciting input on how pharmacy benefit manufacturer (PBM) practices affect patients and payers. Read More
The FDA has withdrawn its approval of TG Therapeutics’ flagship lymphoma drug, Ukoniq (umbralisib), citing the possibility of increased risk of death in those taking the drug — and the company has voluntarily withdrawn the drug from market. Read More
In the latest move in the ongoing feud over their cholesterol-fighting monoclonal antibodies, Regeneron has filed a new antitrust suit against Amgen, accusing the drugmaker of carrying out an “unlawful, anticompetitive bundling scheme” to harm the market for Regeneron’s Praluent (alirocumab) in order to increase sales of Amgen’s competitor product, Repatha (evolocumab). Read More
The approval follows the recommendation of Polivy for this indication from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Read More
The Senate’s bill to reauthorize FDA user fee programs for drugs, biologics and medical devices, introduced last week by Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (N.C.), includes proposed reforms of the FDA’s accelerated approval program, a subject the House declined to address in its version of the user fee program reauthorization. Read More
A bipartisan pair of senators — Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) — are pressing federal agencies to close oversight gaps that delay generic drugs and in turn keep drug prices high. Read More