Industry News

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.”

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.

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with VIEKIRA PAK for 12 weeks.

Aquinox Pharmaceutical Inc., a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology,  announced receipt of official minutes from its December 8, 2015 meeting with the Division of Bone, Reproductive and Urologic Products (DBRUP) of the United States Food and Drug Administration (FDA) and provided an update on its plans for development of AQX-1125 for the treatment of patients with bladder pain syndrome/interstitial cystitis (BPS/IC). Discussed at the meeting were guidance and recommendations regarding proposed pivotal trial designs with AQX-1125 for BPS/IC, as well as additional supportive clinical, preclinical and manufacturing activities that could potentially be required for registration.

Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Immune Design, a clinical-stage immunotherapy company focused on oncology, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for LV305 and G305 for the treatment of soft tissue sarcoma.  LV305 and G305 are the complementary agents that comprise CMB305, Immune Design's "prime boost" cancer immunotherapy product candidate.