Industry News

- Read more about Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) demonstrated superiority to Iressa® (gefitinib)
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).
- Read more about Amgen's Biosimilar Biologics License Application For ABP 501 Accepted by FDA
Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).
- Read more about Immunocore’s IMCgp100 Granted Orphan Drug Designation by US FDA
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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- Read more about Merck announce FDA acceptance of Biologics License Application for bezlotoxumab
Merck , known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.
- Read more about AstraZeneca Together with GSK, J& J and academia to establish translational research fund
AstraZeneca together with GlaxoSmithKline and Johnson & Johnson has partnered with three world-class universities, Imperial College London, the University of Cambridge and University College London (UCL), to create the Apollo Therapeutics Fund. This pioneering new consortium aims to convert outstanding academic science from the three universities into innovative medicines for a broad range of diseases.
- Read more about Fate Therapeutics announces FDA clearance of IND application for ProTmune
Fate Therapeutics, Inc, a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for cancer and immune disorders, announced the U.S. Food and Drug Administration (FDA) has cleared the Company's investigational new drug (IND) application for ProTmune™, a programmed cellular immunotherapy consisting of donor-sourced mobilized peripheral blood cells which have been functionally modulated using two small molecules. The IND is now active and Fate Therapeutics plans to initiate a multi-center, randomized, controlled Phase 1/2 clinical trial in adult patients with hematologic malignancies undergoing mobilized peripheral blood (mPB) hematopoietic cell transplantation (HCT) in mid-2016.

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- Read more about Polyganics Receives FDA 510(k) Clearance for NEUROCAP
Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery, announced it has received FDA 510(k) clearance for NEUROCAP, an innovative device designed to reduce painful neuroma formation and thereby facilitate tissue repair and regeneration.
- Read more about Sandoz Licenses its Biosimilar Rituximab to Kyowa Hakko Kirin in Japan
Sandoz, a Novartis company and the global leader in biosimilars, announced that it has entered into an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd for the distribution and promotion of its biosimilar rituximab - a monoclonal antibody, in Japan.
- Read more about Athenex receive US FDA allowance of the IND application of Oradoxel, the proprietary oral form of Docetaxel
Athenex, Inc. announced that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel. This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug.
- Read more about Nivolumab with Ipilimumab regimen receives expanded FDA approval
U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.