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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The FDA has withdrawn its approval of TG Therapeutics’ flagship lymphoma drug, Ukoniq (umbralisib), citing the possibility of increased risk of death in those taking the drug — and the company has voluntarily withdrawn the drug from market.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
Until a generic version of the drug is available, ViiV will supply Apretude to public programs in “low-income, least-developed and all sub-Saharan African countries” at what it calls a “nonprofit price.” Read More
Under the terms of the accelerated approval, the company must conduct one or more confirmatory clinical trials to demonstrate the treatment’s benefit. Read More
The FDA has put the squeeze on Sanofi’s first steps toward an over-the-counter (OTC) version of Cialis (tadalafil), Eli Lilly’s once-blockbuster erectile dysfunction drug. Read More
In an effort to prepare for future health emergencies, the World Health Organization (WHO) has adopted a resolution geared toward delivering higher quality data and improving the conduct and coordination of clinical trials around the world. Read More
Johnson & Johnson (J&J) has filed a complaint against Aurobindo Pharma charging the Indian generics maker with infringing on patents for J&J’s blockbuster prostate cancer therapy Erleada (apalutamide). Read More
GSK announced yesterday that it is acquiring Cambridge, Mass.-based biopharma company Affinivax in a $3.3 billion deal, picking up at least two novel pneumococcal vaccine candidates and a promising vaccine technology platform. Read More