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Pharma news

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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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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Novo Nordisk’s diabetes drug in China

China Food and Drug Administration (CFDA) has approved Novo Nordisk’s Tresiba (insulin degludec) for the treatment of diabetes in China.

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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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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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EC approves Novartis’s metastatic breast cancer drug

European Commission (EC) approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

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FDA OK’s Gilead Sciences’s hepatitis C drug

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.

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New EU approval for AstraZeneca’s certain breast cancer treatment

AstraZeneca today announced that the European Commission (EC) has approved Faslodex (fulvestrant) for certain metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

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Quantum Genomics raises €8.2 Million, could double it

Quantum Genomics, a biopharmaceutical company focused on cardiovascular diseases, has a completed placement and a capital increase, including the removal of preferential subscription rights, reserved for a category of beneficiaries.

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Ablynx’s Nanobody Fast Track listed by the US FDA, third phase study report in 2017

Ablynx was granted Fast Track designation for caplacizumab, by the that the U.S. Food and Drug Administration (FDA). That’s the company’s first-in-class anti-von Willebrand factor (vWF) Nanobody developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

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