Pharma News

Matinas BioPharma Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy.

Soligenix, Inc. announced that the United States (US) Patent Office granted the patent entitled “Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.”  The newly issued patent claims composition of matter of analogs of dusquetide (research name: SGX94), the Company’s lead development compound.  Dusquetide recently demonstrated positive preliminary results in a Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer patients.  The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform. Similar claims have been granted and/or are being pursued in jurisdictions worldwide.

Alvogen announced the launch of RemurelTM (glatiramer acetate), the first generic equivalent of CopaxoneTM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name RemurelTM and will be launched throughout all Central and Eastern European countries from September 2016 onwards.

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CTD Holdings, Inc. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for its orphan drug product Trappsol® Cyclo™ in the treatment of Niemann-Pick Type C (NPC) disease. CTD will be initiating a Phase I study to investigate safety, tolerability, pharmacokinetic parameters and pharmacological effects of the intravenous administration of Trappsol® Cyclo™, CTD's hydroxypropyl beta cyclodextrin. Trappsol® Cyclo™ has Orphan Drug Designation in both the EU and the US.

Catalyst Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for Firdapse® (amifampridine phosphate) for the treatment of myasthenia gravis.

Sangamo BioSciences, Inc. Announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-FIX, the company's zinc finger nuclease (ZFN)-mediated genome editing product candidate for the treatment of hemophilia B. Sangamo expects to initiate a Phase 1/2 clinical study (SB-FIX-1501) in adult subjects with the disease in 2016.

Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.