Pharmaceuticals, Biotechnology and Life Sciences
FDA has reported that the federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.
Rituxan is used to treat blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.
Allergan has reached a settlement regarding its litigation with Famy Care Limited relating to certain Allergan’s United States Patent covering Restasis (Cyclosporine Ophthalmic Emulsion) 0.05%.
The U.S. Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.
The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.
Bristol-Myers Squibb and IFM Therapeutics have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.
Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.
The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gilead Sciences’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.
The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.
Diplomat Pharmacy will distribute Puma Biotechnology’s new product, Nerlynx, a kinase inhibitor approved by the US Food and Drug Administration (FDA).