Clinical Intelligence

Phase III Lusutrombopag study shows positive efficacy

Friday, October 20, 2017

Shionogi & Co. announced it will present positive efficacy and safety results from a global phase III study (L-PLUS 2) of lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, at the 2017 American Association for the Study of Liver Diseases (AASLD) Liver Meeting to be held October 20-24 in Washington, D.C.

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FDA approves CAR-T cell therapy for large B-cell lymphoma

Friday, October 20, 2017

The FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

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FDA grants Priority Review for Lynparza in metastatic breast cancer

Wednesday, October 18, 2017

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.

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The evolution of mobile technology use in clinical trials

Wednesday, October 18, 2017

William Osler, a founder of Johns Hopkins University, was a clinician ahead of his time. He was one of the first doctors to bring medical students out of the lecture hall and to the patient’s bedside — a revolutionary format change in its day. His 1892 book, The Principles and Practice of Medicine, was labeled as an “imaginative new curriculum” that prevailed for 50 years.1 Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.”

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ACRP advances CRC competency-based standards

Monday, October 16, 2017

The Association of Clinical Research Professionals (ACRP) has launched a new initiative to develop competency standards for clinical research coordinators (CRCs) as part of a larger effort to advance the professionalism of the clinical research workforce. The project will establish minimum standards regarding the knowledge and skill required for entry-level study coordinators and create a hierarchy of competencies focused on performance rather than longevity. Pathways needed for CRCs to advance their careers will be clearly defined and ACRP will develop tools to assess job proficiency, identify gaps and provide training.

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Eli Lilly’s Verzenio grabs Priority Review for advanced breast cancer

Friday, October 13, 2017

Eli Lilly announced that the FDA has granted Priority Review designation for its New Drug Application (NDA) for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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H3 granted orphan designation for hepatocellular carcinoma treatment H3B-6527

Wednesday, October 11, 2017

H3 Biomedicine, a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, announced that the FDA has granted the company an orphan drug designation for H3B-6527, its first solid tumor clinical compound, for the treatment of patients with Hepatocellular Carcinoma (HCC). H3B-6527, a selective, orally bioavailable, and potent covalent inhibitor of fibroblast growth factor receptor 4 (FGFR4), is currently in phase I clinical trials.

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FDA to modernize digital health software regulatory framework

Tuesday, October 10, 2017

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S. The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily the product.”

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