BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.3_2018/ NEWSLETTER MENSILE

11 apr, 2018

Diasorin receives Fda clearance for the Liaison Brahms Pct II Gen assay to detect severe bacterial infections (e.g. Sepsis)
DiaSorin announces that it has received clearance from the US Food and Drug Administration to market the LIAISON BRAHMS PCT II GEN assay for Sepsis’ diagnosis through the quantitative determination of procalcitonin (PCT). Sepsis is a systemic inflammation caused by uncontrolled bacterial infection. Despite advances in modern medicine, including antibiotics and vaccines, sepsis affects over 26 million people every year in the world and remains the primary cause of death from infection. Carlo Rosa, CEO of DiaSorin Group, commented: “Through the launch of this new test, we further strengthen our positioning in the US diagnostic market, achieving on the time set another important goal of our 2017-2019 plan”.
More info: https://www.diasorin.com/sites/default/files/allegati_pressrel/pr_pct_usa_eng.pdf

AXXAM expands its natural products service business 
Axxam announces the acquisition of all shares of IMAX Discovery GmbH held by IMD Natural Solutions GmbH to make IMAX Discovery a subsidiary of AXXAM. In the course of this transaction, IMAX Discovery acquired the natural products libraries of INS. With this acquisition and through IMAX Discovery, AXXAM has expanded its discovery services portfolio to the food & beverage industry and emphasizes its commitment to building its service business with unique offerings in natural product innovation as well as flavor solutions. As a consequence, AXXAM will also transfer its service business within the fragrance field into IMAX Discovery.
More info: http://www.axxam.com/sites/default/files/uploads/news/attachments/233/praxxam-imax180322.pdf
 
Sandoz receives positive CHMP opinion for proposed biosimilar infliximab 
Sandoz, a Novartis division and the global leader in biosimilars, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of infliximab, a proposed biosimilar to reference medicine infliximab. 
The CHMP opinion recommends the proposed Sandoz biosimilar infliximab for the treatment of all indications of its reference medicine across gastroenterology, rheumatology and dermatology. More info: https://www.sandoz.com/news/media-releases/sandoz-receives-positive-chmp-opinion-proposed-biosimilar-infliximab

Novartis presents predictability data for brolucizumab in nAMD from pivotal HAWK and HARRIER trials at ARVO 
Novartis will present new data from the HAWK and HARRIER Phase III trials at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting, Honolulu, April 29 - May 3. Data on a secondary endpoint examining the predictability of 12-week dosing for patients with neovascular age-related macular degeneration (nAMD) treated with brolucizumab (RTH258) will be presented for the first time at the meeting. More info: https://www.novartis.com/news/media-releases/novartis-present-predictability-data-brolucizumab-namd-from-pivotal-hawk-and-harrier-trials-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
Novartis announced that it has entered into an agreement and plan of merger with AveXis, Inc. to acquire the US-based Nasdaq-listed clinical stage gene therapy company for USD 218 per share or a total of USD 8.7 billion in cash. The transaction was unanimously approved by the Boards of both companies. 
AveXis has several ongoing clinical studies for the treatment of SMA, an inherited neurodegenerative disease caused by a defect in a single gene, the survival motor neuron (SMN1). The lead AveXis gene therapy candidate, AVXS-101, has highly compelling clinical data in treating SMA Type 1, which is the number one genetic cause of death in infants, where 9 out of 10 infants do not live to their second birthday or are permanently ventilator dependent. It is estimated that one out of every 6,000-10,000 children born is affected by some form of SMA. More info: https://www.novartis.com/news/media-releases/novartis-enters-agreement-acquire-avexis-inc-usd-87-bn-transform-care-sma-and-expand-position-gene-therapy-and-neuroscience-leader