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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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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Biosimilars legislation approved in New Jersey

Wednesday, November 11, 2015

Legislation sponsored by Assembly Democrats of the New Jersey General Assembly (Pamela Lampitt, Daniel Benson, Shavonda Sumter, Nancy Pinkin, and Herb Conaway Jr., M.D.) to make it easier for consumers to obtain more cost-effective, “generic” versions of biological medicines used to treat conditions such as rheumatoid arthritis, anemia, psoriasis and various forms of cancer has been signed into law.

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