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  • Biofrontera , the biopharmaceutical company focusing on sun-induced skin cancer, announced recent progress on the ongoing approval process for Ameluz® and BF-RhodoLED® in the USA. FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.

  • Aortica Corporation  announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study sponsored by Dr. Benjamin Starnes – Chief of Vascular Surgery at the University of Washington (UW).  The supplement names Aortica as the supplier of both a Fenestration Alignment Software and a patient-specific 3-D printed fenestration template.

  • Boehringer Ingelheim announced the results of the LUX-Lung 7 trial. Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib, versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). The Phase IIb trial met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start, and discontinuation of treatment for any reason).

  • Immunocore, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune disease,  announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead programme, IMCgp100, for the treatment of uveal melanoma. The Orphan Drug status qualifies Immunocore for a number of development incentives and will enable Immunocore to receive fast track registration for IMCgp100, its lead ImmTAC (Immune mobilising mTCR Against Cancer) therapeutic.

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