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Monthly Archives: August 2017

FDA Approves Teva’s Austedo for Treatment of Tardive Dyskinesia in Adults

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO® was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017. Tardive dyskinesia is a …

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New Data Show Durable Response in Patients with Advanced Melanoma Treated with Epacadostat in Combination with Keytruda

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the European Society for Medical Oncology (ESMO) has published an abstract (#1214O) containing new and updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with the anti-PD-1 KEYTRUDA® (pembrolizumab), marketed by Merck & Co., …

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FDA Approves Novartis’ CAR-T Cell Therapy Kymriah for Treatment of B-Cell ALL

novartis Basel, August 30, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriah(TM)(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia …

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FDA’s Statement on New Policy Steps to Ensure Proper Oversight of Stem Cell Therapies & Regenerative Medicine

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling …

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CSL Behring to Acquire Calimmune and its Proprietary Stem Cell Gene Therapy Platform

KING OF PRUSSIA, Pa., Aug. 28, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that it has agreed to acquire Calimmune, Inc., a biotechnology company focused on the development of ex vivo hematopoietic stem cell (HSC) gene therapy with R&D facilities in Pasadena, California and Sydney, Australia for …

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Gilead Sciences to Acquire Kite Pharma for $11.9 Billion

FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 …

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FDA Approves AstraZeneca’s Faslodex as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FASLODEX® (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine …

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Biogen Announces New Data from Phase 1b Study of its Investigational Alzheimer’s Disease Drug

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (NASDAQ: BIIB) today announced results from a recently conducted analysis of the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, the company’s investigational treatment for early Alzheimer’s disease. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up …

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FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for …

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Delivers Medicine to Cancer Cells While Protecting Healthy Cells

Cancer treatments, including chemotherapy, have helped many of those who have been diagnosed with the disease to go on to live healthy lives. Nevertheless, chemotherapy takes a toll on the body. During treatment, chemotherapy attacks all of the body’s cells, not just cancer cells. The result destroys healthy cells, causing …

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