Clinical Intelligence

Adaptimmune initiates lung cancer trial

Monday, November 30, 2015

Adaptimmune Therapeutics, a clinical stage biopharmaceutical company based in Oxfordshire, U.K. and Philadelphia, has initiated a study of its affinity enhanced T-cell therapy targeting the NY-ESO-1 cancer antigen in patients with stage IIIb or stage IV non-small cell lung cancer (NSCLC), the most common type of lung cancer, representing 85% of lung cancers.

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Merck, Pfizer receive FDA Breakthrough Therapy for Avelumab

Monday, November 23, 2015

Merck, of Darmstadt, Germany, and Pfizer have announced that the FDA has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.

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Pfizer reports positive results from phase III NSCLC trial

Monday, November 23, 2015

Pfizer has announced that PROFILE 1029, a phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet.

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Viking Therapeutics submits IND application for VK2809

Wednesday, November 18, 2015

Viking Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, has submitted an investigational new drug (IND) application to FDA to conduct a phase II study of VK2809 in patients with hypercholesterolemia and fatty liver disease.

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FDA approves new non-small cell lung cancer pill

Monday, November 16, 2015

The FDA has granted Accelerated Approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) now is approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

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