JERUSALEM--(BUSINESS WIRE)--May 31, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD)....
TEVAPHARM.COM
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Klöckner Pentaplast will present the latest range of pharmaceutical packaging solutions and services at ASEAN Pharma Packaging Conference 2017 (APPCON) March 16-17, 2017, in Singapore....
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Pfizer and Astellas’ Xtandi is gunning for a new indication in prostate cancer, and they say Sunday's new data complement the supporting evidence they’ve already generated. Sunday at the American Society of Clinical Oncology annual meeting, researchers trumpeted datafrom an investigator-sponsored study in metastatic hormone-sensitive prostate cancer (mHSPC). The study showed Xtandi slashed the risk of death by 33% compared with other non-steroidal androgen-fighting drugs. Eighty ...
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A second cut-price biosimilar of Amgen’s Neulasta (pegfilgrastim) long-acting white blood cell booster is to hit the EU market after the European Commission approved Mundipharma’s Pelmeg. Pelmeg can now be used in Europe for patients with neutropenia and febrile neutropenia in adult cancer patients treated with chemotherapy. Pelmeg was developed by Spain’s Cinfa Biotech, which Mundipharma acquired last month, after regulators on the European Medicines Agency’s Committee f...
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Tarrytown, NY-based Regeneron Pharmaceuticals and Paris-based Sanofi restructured a 2015 agreement to develop immuno-oncology (I/O) treatments. That deal was scheduled to wrap in 2020, but the revision adds two clinical-stage bispecific antibodies to the collaboration. The revision lets Regeneron hold all rights to its other I/O discovery and development programs. It gives Sanofi more flexibility in advancing its early-stage I/O pipeline by itself. Under the terms of the restructuring, Sanofi is...
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More Australian women will have access to a preventative breast cancer drug that has today been listed on the Pharmaceutical Benefits Scheme, the Federal Government says....
ABC.NET.AU
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