The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Allergan’s Avycaz (ceftazidime and avibactam) for priority review.
Eli Lilly has made certain leadership changes, promoting several experienced Lilly leaders to executive roles, effective in 2018.
The U.S. Food and Drug Administration has approved Eli Lilly’s Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
Novartis has joined forces with researchers from the University of California, Berkeley, to develop new technologies for the discovery of next-generation therapeutics, pursuing the vast number of disease targets in cancer and other illnesses that have eluded traditional small-molecule compounds and are considered “undruggable.”
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.