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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
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