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FDA accepts sNDA filing for Allergan’s pneumonia drug

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.

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Eli Lilly in leadership chances

Eli Lilly has made certain leadership changes, promoting several experienced Lilly leaders to executive roles, effective in 2018.

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FDA OK’s Eli Lilly’s breast cancer drug

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).

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Novartis and UC Berkeley collaborate to tackle ‘undruggable’ disease targets

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.”

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Federal judge orders U.S. company to stop distributing unapproved drugs

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.

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Sandoz proposed biosimilar rituximab accepted for review by the FDA

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.

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Allergan settles with Famy Care over patent litigation

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%.

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FDA OK’s Novo Nordisk’s diabetes drug

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.

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FDA grants priority review designation to Gilead Sciences’s HIV drug

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.

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Bristol-Myers Squibb strengthens its oncology pipeline – buys IFM Therapeutics

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.

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