BioInItaly Newsletter

La vetrina del biotech italiano all’estero

N.9/ NEWSLETTER MENSILE 2017

21 dic, 2017

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
MolMed S.p.A. is proud to announce that it obtained its first national marketing authorization for its proprietary product, Zalmoxis®: the Board of Directors of AIFA approved the agreement negotiated between AIFA’s Prices and Reimbursement Committee (CPR) and MolMed, in which the price and reimbursement for Zalmoxis® medicinal product were defined. Zalmoxis® is MolMed’s first patient specific cell therapy product, based on genetically engineering of the immune system, administered following haploidentical haematopoietic stem-cell transplantation (HSCT) from partially compatible donors to adult patients with leukaemia and other high-risk haematologic malignancies. Zalmoxis® is administered from the 21st day post-transplantation and foresees up to a maximum of 4 infusions per patient based on the achievement of immune-reconstitution. More info: http://www.molmed.com/sites/default/files/uploads/press-releases/3225/3225_1513170251.pdf

DiaSorin lauches a new Simplexa Bordetella Direct molecular test 
DiaSorin receives CE Mark for a new Bordetella molecular diagnostic test. Simplexa Bordetella Direct is designed to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in human nasopharyngeal swabs. The assay has also been submitted for FDA clearance. "We are proud to provide a new assay for the LIAISON MDX instrument for our laboratory partners worldwide," said Michelle Tabb, Vice President of Research and Development, DiaSorin Molecular LLC. "The addition of the assay further enhances our respiratory menu offering in the marketplace. We are fulfilling our commitment to expand our infectious disease portfolio with the development of new tests aimed at accommodating the shifting needs of today's laboratories." More info: http://www.diasorin.com/sites/default/files/allegati_pressrel/pr_diasorin_-_bordetella_eng.pdf

Bausch + Lomb and Nicox announce FDA approval of Vyzulta™
Valeant Pharmaceuticals International, wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, and Nicox S.A., an international ophthalmic company, announced that the FDA has approved the New Drug Application (NDA) for VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%). VYZULTA, the first prostaglandin analog with one of its metabolites being nitric oxide (NO), is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. “With today’s approval of VYZULTA, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease,” said Joseph C. Papa, chairman and CEO, Valeant. “We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.” “VYZULTA represents the first FDA approved therapy developed through our proprietary NO donating research platform,” said Michele Garufi, chairman and CEO of Nicox. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.” VYZULTA was licensed on a global basis to Bausch + Lomb from Nicox. As a result of this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement. More info: http://www.nicox.com/assets/files/20171102-FINAL-VYZULTA-FDA-Approval-News-Release.pdf