Merck Resubmits U.S. Application for Cladribine Tablets
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- Category: Merck Group
Merck KGaA announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Cladribine Tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).
Phase III study showed Avastin-based regimen helped women with advanced ovarian cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced results from a Phase III study of Avastin (bevacizumab) that showed women with previously untreated advanced ovarian cancer who received Avastin in combination with chemotherapy, followed by the continuation of Avastin alone, had a 39 percent improvement in the likelihood of living longer without the disease worsening compared to chemotherapy alone.
Phase 3 Study Showed MACUGEN® Improved Vision Over Standard of Care
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- Category: Pfizer
Results from a Phase 3 study demonstrate MACUGEN® (pegaptanib sodium) significantly improved vision in patients with diabetic macular edema (DME), a complication of diabetes that is a leading cause of blindness in people of working age.(1)
Merck Announces Launch of Pioneering Collaborative Cancer Trials Network
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- Category: Merck
Merck announced the launch of the Merck Oncology Collaborative Trials Network, a pioneering clinical trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer.
FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women with Osteoporosis
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- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Prolia(TM) (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Victoza® to be launched in Japan in June
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- Category: Novo Nordisk
Novo Nordisk today announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan's Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.
AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application
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- Category: AstraZeneca
AstraZeneca has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the new drug application for AXANUM (aspirin/esomeprazole magnesium) tablets.
More Pharma News ...
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- Novartis announces extension of US regulatory priority review period for FTY720
- Results of the clinical study CALYPSO Published in The Journal of Clinical Oncology
- Genzyme Receives FDA Approval for Lumizyme for Pompe Disease
- European Medicines Agency maintains position on the continued use of Rotarix
- Ranibizumab significantly more effective than standard of care in treating vision loss due to DME
- Abbott to Become No. 1 Pharmaceutical Company in India