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selvita and the leukemia & lymphoma society announce partnership to advance sel120 into phase i for aml patients
Selvita S.A. and The Leukemia & Lymphoma Society (LLS) announced a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML). Selvita has discovered and is...
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FDA Issues Emergency Use Authorization for Thermo Fisher Scientific’s Zika Virus Assay
Thermo Fisher Scientific, the world leader in serving science announced that the U.S. FDA has issued an Emergency Use Authorization for the company's new TaqPath Zika Virus Kit. The TaqPath Zika Virus Kit is authorized only...
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Aridis Is Enrolling Patients in Pivotal Trial of Its Antibiotic-resistant Pneumonia Therapy Aerucin
Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced that it is now actively enrolling patients in a global pivotal study of Aerucin®, the Company’s broadly reactive monoclonal antibody...
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KALYDECO® ( ivacaftor ) Approved By FDA For More Than 600 People Ages 2 And Older With Cystic Fibrosis Who Have Certain Residual Function...
Vertex Pharmaceuticals Incorporated announced that the U.S. FDA has approved KALYDECO® (ivacaftor) for use in more than 600 people with CF ages 2 and older who have one of five residual function mutations that result in a splicing defect...
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Eisai Submits Simultaneous Applications in The United States and Europe for Lenvatinib in Hepatocellular Carcinoma
Eisai Co., Ltd. announced that it has submitted applications to the US FDA and the EMA for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (HCC). This follows...
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Lack Of Confidence In Serialization Preparations Highlighted By New Research
More than one third (40 per cent) of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research. As the FDA has announced plans...
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Broad range of multifunctional mineral excipients
At CPhI in Frankfurt, Omya will showcase its Omyapharm® multifunctional excipient platform based on functionalized calcium carbonate, a highly structured mineral. Omyapharm® is suitable for numerous applications, including solid oral dosage forms such as conventional tablets...
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