ViiV Healthcare’s Apretude (cabotegravir), a recently approved long-acting injectable for preventing HIV in adults and adolescents, isn’t cost-effective despite offering new hope against the deadly disease, a new analysis contends.…
Continuing resolution (CR) funding for the FDA at fiscal 2021 levels denies the FDA increased funding as Congress intended, limits new program starts and makes it difficult for the agency…
Drug wholesalers McKesson, AmerisourceBergen and Cardinal Health, and the Janssen subsidiary of Johnson & Johnson (J&J) have agreed to pay a combined $590 million to settle lawsuits with Native American…
Gilead Sciences will pay GlaxoSmithKline (GSK) $1.25 billion plus royalties to end a four-year-old patent fight between Gilead and human immunodeficiency virus (HIV)-focused ViiV Healthcare, a company launched in 2009…
The FDA has approved the first-ever generic of AbbVie’s 20-year-old immunomodulator Restasis for dry eye — Mylan Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05 percent single-use vials. Source: Drug Industry Daily
The University of Pennsylvania is suing Genentech for patent infringement of four pharmacologically related breast cancer chemotherapy agents, alleging that the drugs were originally created by university researchers and fully…
Gilead Sciences will pay GlaxoSmithKline (GSK) $1.25 billion plus royalties to end a four-year-old patent fight between Gilead and human immunodeficiency virus (HIV)-focused ViiV Healthcare, a company launched in 2009…
At the FDA’s request, Pfizer and partner BioNTech have asked the agency to expand their Emergency Use Authorization (EUA) for the Comirnaty COVID-19 vaccine to include a two-shot series for…
The National Institutes of Health (NIH) will decide this month whether Pfizer’s patent on Xtandi (enzalutamide), a prostate cancer drug’s that’s five times pricier in the U.S. than it is…
It sure appears as though Robert Califf’s second confirmation as FDA commissioner could be in jeopardy. Source: Drug Industry Daily