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KemPharm, Inc. , a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced preliminary results of KP415.109.

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 being developed to treat acute pneumonia caused by Gram-negative bacteria Pseudomonas aeruginosa.

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 in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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).

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.

BRITISH biotech business TopiVert has recently initiated clinical trials with two of its narrow spectrum kinase inhibitor (NSKI) drug candidates following support from Onyx Scientific.