BioInItaly Newsletter

La vetrina del biotech italiano all’estero


25 lug, 2016

Zambon lauches Xadago® (safinamide) in the Netherlands for patients with mid-to-late-stage Parkinson’s Disease
Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system and pain, announced the launch of Xadago® (safinamide) in the Netherlands for the treatment of mid- to late-stage Parkinson’s disease (PD). Elena Zambon, President of Zambon, said: "Zambon has a strong commitment to Parkinson’s disease, and we continue to look at ways to address unmet needs of patients that can benefit from new treatment options in the CNS therapeutic area."
With the addition of the Netherlands, Xadago® is now available in ten countries: Germany, Switzerland, Spain, Italy, Belgium, Denmark, Sweden, UK and Luxembourg. For more information:

MolMed receives positive COMP opinion on the orphan drug designation for Zalmoxis®
Following the positive opinion on the Conditional Market Authorisation issued on June 24 by the CHMP, in conjunction with the CAT (Committee for Advanced Therapies), the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), just confirmed the orphan drug designation for Zalmoxis, the first patient-specific immunogene therapy, as adjunctive treatment in haploidentical haematopoietic stem-cell transplantation (haplo-HSCT) for adult patients with high-risk haematological malignancies. Riccardo Palmisano, CEO of MolMed S.p.A., commented: “This new positive opinion coming from COMP is highly significant and very important for MolMed. It confirms the clinical benefit of Zalmoxis in addressing a significant unmet clinical need for such a life-threatening condition” More info:

Advanced Accelerator Applications Announces FDA Priority Review for Lutathera
AAA announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. “We are encouraged that the FDA has granted Priority Review for Lutathera as a potential treatment for GEP-NETs,” said Stefano Buono, Chief Executive Officer of AAA. “We believe this action emphasizes the need to improve the lives of these patients.” More info:

Kedrion Biopharma consolidates presence on Russian Market
Nikolay Semenov, CEO of Nacimbio (National Immunobiological Company, RosTECH group) and Maria Lina Marcucci, Kedrion Biopharma Board member and Chairman of Sestant Internazionale Spa, which is Kedrion’s majority shareholder, signed a joint venture agreement. The Castelvecchio Pascoli-based company will collaborate in relaunching the Russian plant in Kirov, which produces plasma-derived medicines. According to the agreement between the two companies, the facility will be operational in 2019, once the plant renovation, the installation of new equipment for production and all activities included in the transfer of experience, expertise and technologies from Kedrion to Nacimbio, have been completed. More info: