BioInItaly Newsletter

La vetrina del biotech italiano all’estero


31 ago, 2017

MolMed and Dompé signed strategic commercialization and supply agreements for Zalmoxis® in Europe 
MolMed S.p.A. and Dompé farmaceutici S.p.A. jointly announced having entered into a 15 year exclusive license and distribution agreement granting Dompé the exclusive right and obligation to conduct all activities aimed at promoting, marketing, exploiting, distributing and selling Zalmoxis in all member countries of the current European Economic Area (EEA) and an option right for Australia, Switzerland and Turkey. Under the terms and conditions of the license and distribution agreement Dompé shall also perform and/or complete market access activities and take care of negotiating pricing and reimbursement of Zalmoxis in each interested country other than Italy. MolMed will be responsible for performing market access activities, pricing and reimbursement negotiations in Italy, maintaining the Conditional Marketing Authorization and complying with the post approval commitments imposed by EMA in order to obtain full Authorization for Zalmoxis. More info:

Axxam enters into a Research Collaboration with Enamine for the enhancement of the Axxam Screening Collection
Axxam S.p.A. and Enamine Ltd. announced the start of a Research Collaboration to enhance the Axxam small molecule screening library with the addition of a further set of compounds aimed at early-stage CNS drug discovery, achieving a total library size of ca. 280,000 compounds. Over the course of the collaboration, Axxam and Enamine scientists will work together to apply a series of literature and proprietary chemoinformatics principles based on generating a highly diverse set of compounds with properties aimed at crossing the blood-brain barrier. Enamine will then provide these compounds, which will significantly augment the existing CNS compound collection at Axxam. This is the latest phase of a long-standing relationship between the two companies that resulted in the construction of the current AXXDIV2.0 library at Axxam. More info:

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) 
Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt® (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. If approved by the European Commission (EC), Rydapt will be indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response, followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3 mutation-positive. Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia. If approved, Rydapt will be the first targeted treatment available in the European Union (EU) for newly diagnosed FLT3 mutation-positive AML patients and advanced systemic mastocytosis (SM) patients. The opinion follows the recent US Food and Drug Administration (FDA) 2017 approval of Rydapt for FLT3-mutated AML and advanced SM on April 28 and the Swissmedic approval on May 4. More info:
“Fabbrica diffusa”: the network of industry 4.0 demonstrators. ComoNExT, Cariplo Factory and Synesis together for the company of the future
Consistently with its mission of gathering the best of available innovation and transferring it to the territory, the ambitious project promoted by ComoNExT – Innovation Hub aims to realize the first factory model spread across Europe through the development of an open project that allows individuals Several to share in coordinated energy and investment efforts to create new generation industrial centers, covering all the technology areas of Industry 4.0 launched by the Government. It will result in a real Factory 4.0, whose single areas and production islands will be distributed in different cities and yet closely linked to each other. Fabbrica diffusa (widespread factory) Project, with a demonstration value for companies that do not yet know how to approach the theme of Innovation while experiencing the urgency, is developing in parallel with a more cultural activity aimed at raising even in smaller companies the awareness of the need to approach new business models connected to Industry 4.0
Fabbrica Diffusa Project involves:
Cariplo Factory – Milan
Area Science Park – Trieste
Friuli Innovation – Udine
Polo Mechatronics, Trentino Development – Rovereto
Padano Technological Polo – Lodi
Liuc – Castellanza (VA)
The group can rely on the technical contribution of Synesis, a company established in ComoNExT, and on support from key players who provide the necessary enabling infrastructure: Cisco, Fastweb, Kuka, Microsoft, Oracle and SAP.
Legnani Legal – established inside the park – supports the development of the project from a legal point of view (business network). More info: