Industry News

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI® , an etanercept biosimilar referencing Enbrel®. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make BENEPALI available for patients in the coming weeks.

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.
amenable to exon

Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.

Impax Laboratories, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets

Volpara Solutions, the leading provider of automated breast density assessment and quantitative breast imaging tools, announced  that it has received a new 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Volpara Density Maps, a new solution designed to help radiologists address the requirement in the BI-RADS 5th Edition Atlas to provide “an overall assessment of the volume of attenuating tissues in the breast, to help indicate the relative possibility that a lesion could be obscured.”

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Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.

The National Institute of Cholera and Enteric Diseases (NICED) here on Friday inked a deal with the Bengal Chamber of Commerce and Industry (BCCI) to undertake cutting-edge research on enteric diseases including hepatitis C, and see through translation of research outputs for community outreach.

CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that China’s Food and Drug Administration (CFDA) has accepted for review its import drug registration application for MARQIBO® (vinCRIStine sulfate LIPOSOME injection).

Immunovaccine Inc, a clinical stage vaccine and immunotherapy company, announced U.S. Food and Drug Administration (FDA) and Health Canada clearance to initiate a clinical study of DPX-Survivac in combination with low-dose cyclophosphamide and epacadostat. Resulting from a recently announced collaboration between Immunovaccine and Incyte Corporation (“Incyte”), the Phase 1b clinical trial will assess the safety and effectiveness of Immunovaccine’s novel T cell activating therapy, DPX-Survivac, along with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease. Immunovaccine anticipates starting the trial, which Incyte will co-fund under the terms of the agreement between the two companies, by Q2 2016.