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  • Pembrolizumab (trade name: Keytruda) was initially introduced for the treatment of melanoma. Since July 2016, the monoclonal antibody has also been available for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express the T-cell receptor ligand PD-L1 and who have received a prior chemotherapy regimen. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapy also for these patients.

  • Oragenics announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AG013, the Company’s lead therapeutic candidate for the treatment of OM. Oragenics expects to file an Investigational New Drug (IND) update and initiate a Phase 2 study with AG013 in the United States and Europe in early 2017.

  • Novartis  announced it has acquired Selexys Pharmaceuticals Corporation, a company specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis exercised its right to acquire Selexys following receipt of results of the SUSTAIN study, a Phase II trial evaluating the use of SelG1, an anti-P-selectin antibody, in the reduction of vaso-occlusive pain crises in patients with sickle cell disease (SCD). Results from the study will be presented during the Plenary Scientific Session at the 58thAmerican Society of Hematology (ASH) Annual Meeting on December 4, 2016, in San Diego, California.

  • Aduro Biotech, Inc. ,a biopharmaceutical company with three distinct immunotherapy technologies,  announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.

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  • Sandoz, a Novartis division, and the pioneer and global leader in biosimilars,  announced the publication of the EGALITY study in the British Journal of Dermatology. The confirmatory clinical safety and efficacy study shows Sandoz biosimilar etanercept is equivalent to the originator product, Enbrel®***, in more than 500 adult patients over 52 weeks.

  • Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, announced the issuance of a United States patent covering Oxaydo (oxycodone HCI, USP) tablets for oral use only–CII. Egalet licensed Oxaydo from Acura Pharmaceuticals and launched the product in the United States in September 2015.

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