BioInItaly newsletter

Inside the Italian biotech
  • 22 May, 2018
    Summary
    Novartis and Amgen announce FDA approval of Aimovig™ (erenumab), a novel treatment developed specifically for migraine prevention
    Acousia Therapeutics Announces 10 Million euros Series B Financing to Advance its Hearing Loss Portfolio
    EryDel Raises 26.5 Million euros in Financing
    MolMed signs Master Service Agreement with Boston Children’s Hospital for the supply of lentiviral vectors 
    Chiesi Group receives the European Marketing Authorisation for Lamzede® (velmanase alfa) 
  • 11 Apr, 2018
    Summary
    Diasorin receives Fda clearance for the Liaison Brahms Pct II Gen assay to detect severe bacterial infections (e.g. Sepsis)
    AXXAM expands its natural products service business 
    Sandoz receives positive CHMP opinion for proposed biosimilar infliximab 
    Novartis presents predictability data for brolucizumab in nAMD from pivotal HAWK and HARRIER trials at ARVO 
    Novartis enters agreement to acquire AveXis Inc. for USD 8.7 billion to transform care in SMA and expand position as a gene therapy and Neuroscience leader
  • 06 Mar, 2018
    Summary
    The European Medicines Agency accepts regulatory submission for Forxiga in adults with type-1 diabetes
    Diasorin signs an agreement with the Italian tax authority granting tax relief under the Italian patent box regime 
    MolMed and Miltenyi Biotec: EMA approves the utilization of the CliniMACS Prodigy® equipment in the commercial manufacturing process of Zalmoxis®
    Dompé announces Zalmoxis® product launch in Germany
  • 19 Jan, 2018
    Summary
    Zalmoxis®: price & reimbursement dossier filed in Germany, where the product can be prescribed and reimbursed as of January 15th
    Prestigious international recognition for Clonit
    Axxam and Proximagen enter into a strategic collaboration for the discovery of novel molecules against targets for CNS disorders, pain and inflammation
    QIAGEN and DiaSorin partner to offer fully automated tuberculosis detection with QuantiFERON-TB Gold Plus available on LIAISON analyzer systems 
    Rewind Therapeutics, founded by Axxam and CD3, focusing on myelin-related diseases, raises €15.2 million in Series A Financing Round
  • 21 Dec, 2017
    Summary
    AIFA set the reimbursement price for Zalmoxis® at EUR 149.000 per infusion, gross of discounts foreseen by law, and also established a flat fee per patient
    DiaSorin lauches a new Simplexa Bordetella Direct molecular test 
    Bausch + Lomb and Nicox announce FDA approval of Vyzulta™
  • 13 Nov, 2017
    Summary
    Kedrion and Cerus enter distribution agreement for Intercept in Italy 
    leadxpro and Axxam enter into a collaboration on a GPCR lead discovery project
    Genenta Science has raised $8M (€7M) in the Series B fundraising round 
    Axxam enters into research collaboration with Sanofi in the field of neurodegeneration
    SCID Treatment Funded in UK
  • 31 Aug, 2017
    Summary
    MolMed and Dompé signed strategic commercialization and supply agreements for Zalmoxis® in Europe 
    Axxam enters into a Research Collaboration with Enamine for the enhancement of the Axxam Screening Collection
    Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM) 
    “Fabbrica diffusa”: the network of industry 4.0 demonstrators. ComoNExT, Cariplo Factory and Synesis together for the company of the future
  • 14 Jul, 2017
    Summary
    SOL Group Acquires Majority Stake in Personal Genomics
    Xadago® (Safinamide) now available in the U.S. for Parkinson’s disease patients
    Diasorin launches iam cbfb-myh11, completing the diagnostic test menu for molecular screening of acute myeloid leukemia by q-lamp  
    MolMed and TTY Biopharm entered into an exclusive agreement to commercialise Zalmoxis® in certain Asian territories    
    Axxam coordinates European research project on chronic pain for innovative medicines
    Novartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) 
    Astra Zeneca - CHMP positive recommendation is based on Phase III data demonstrating a 20% reduction in risk of disease worsening or death over anastrozole 
  • 12 Jun, 2017
    Summary
    Newron Pharmaceuticals Announces Expansion of STARS Study to Include Patients Under 13 Years of Age  Recruitment for potentially pivotal study in patients suffering from Rett syndrome ongoing in the USA, Europe, Asia and Australia 
    DiaSorin launches the new Liaison Androstenedione test for the evaluation of adrenal and gonadal functionality 
    Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
    Dompé receives positive CHMP opinion in Europe for Oxervate® (cenegermin eye drops) for the treatment of adult patients with moderate or severe neurotrophic keratitis 
    Novartis drug Tasigna receives EU approval for inclusion of Treatment-free Remission (TFR) data in product label  
  • 11 May, 2017
    Summary

    AstraZeneca and Pieris Pharmaceuticals collaborate to develop and commercialise Anticalin-based inhaled treatments for respiratory diseases
    MolMed and Megapharmenter into a license and distribution agreement for Zalmoxis® in Israel
    Valeo Pharma and Zambon form partnership for Parkinson’s disease treatment Xadago® (safinamide) in Canada
    Waste: 100% success in test on the use of biodegradable carrier bags in anaerobic digestion plants in Germany
    Diasorin receives authorization for the distribution of zika IgM test in Europe

  • 06 Apr, 2017
    Summary
    Meiji Seika and Eisai enter into a collaboration for the development and commercialization of safinamide in Parkinson’s disease for Japan and Asia 
    Tagrisso (osimertinib) receives US FDA full approval
    Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review 
    ZCube, Research Venture del gruppo farmaceutico Zambon, annuncia un accordo con Italian Angels for Biotech (IAB) per l’individuazione e lo sviluppo di start-up innovative nel campo delle Life Sciences
    EryDel announces start of ATTEST, a Pivotal Phase III Trial of EDS  in Ataxia Telangiectasia (A-T)
  • 28 Feb, 2017
    Summary
    Advanced Accelerator Applications Announces Addition of NETSPOT® to National Comprehensive Cancer Network® Guidelines for Evaluation of NETs
    Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 
    MolMed and Rocket Pharma establish a collaboration agreement in the field of gene therapy for the treatment of Fanconi Anemia
    ZS-9 (sodium zirconium cyclosilicate) receives positive CHMP opinion for the treatment of hyperkalaemia
    DiaSorin launches its new Simplexa C. Difficile direct molecular test in the US market
    AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada
    MolMed and TTY Biopharm entered into a term sheet to commercialise Zalmoxis® in certain Asian territories
    Axxam and Fulcrum Therapeutics Initiate a Partnership for the Provision of Drug Discovery Services for Genetic Diseases