- FDA grants orphan desig­na­tion for PAT-SM6 in multiple myeloma
- Provides 7 years market exclusivity in the USA post approval

Melbourne, Australia (Press Release) - Patrys Limited (ASX: PAB), a clin­i­cal stage bio­technology com­pany, has received con­firmation of Orphan Medicinal Product Designation for its lead anti-cancer prod­uct PAT-SM6, from the USA Food and Drugs Admin­istra­tion (FDA).

PAT-SM6 has pre­vi­ously been granted orphan drug desig­na­tion for multiple myeloma in Europe.

Orphan prod­uct desig­na­tion is intended to provide incentives to encourage com­pa­nies to pursue cures and treat­ments for rare diseases with high unmet …

This grant awarded to Northwest Natural Health Specialty Care Clinic marks the first time a global pharma­ceut­i­cal com­pany has contracted with an independent naturopathic clinic to in­ves­ti­gate a natural medicine com­bi­na­tion--with a state-of-the-art cancer drug--for relief of cancer treat­ment side effects.

Seattle (Press Release) - Northwest Natural Health Specialty Care Clinic (NNH) announced today it has been awarded a $560,000 research grant by Millennium: The Takeda Oncology Company to conduct a multiple clin­i­cal site in­ves­ti­ga­tion into the use of natural medicine to mitigate a side effect of bor­tez­o­mib (Velcade®), an FDA approved, new …

• Expected NDA filing mid-2014.
• Granted Orphan designation by the FDA as a conditioning treatment for use in autologous transplant for patients with multiple myeloma. If approved, will be the only drug approved for this indication.
• In a previous clinical study, Captisol-enabled melphalan met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.

Henderson, NV (Press Release) - Spectrum Phar­ma­ceu­ti­cals (NasdaqGS: SPPI), a bio­technology com­pany with fully integrated commercial and drug devel­op­ment operations and a pri­mary focus in hematology and …

Washington, DC (Press Release) - New research ties preparative procedures and com­pli­ca­tions as­so­ci­ated with blood or bone marrow trans­plan­ta­tion (stem cell trans­plan­ta­tion, SCT) with diminished sexual health in both men and women who have undergone the lifesaving procedure. Study data, published today in Blood, the Journal of the American Society of Hematology (ASH), con­firm chronic graft-versus-host disease (GVHD), a serious com­pli­ca­tion that occurs when donor cells attack the recipient’s cells, as a poten­tial source of sexual dysfunction and are the first to dem­onstrate an association between total body irradiation and sexual dysfunction in men. This study …

Company Completes Key Step in Process to Submit Product Application

Philadelphia (Press Release) - Lannett Company, Inc. (NYSE MKT: LCI) today announced that it has suc­cess­fully com­pleted a key step in its effort to submit to the U.S. Food and Drug Admin­istra­tion (FDA) an Abbre­vi­ated New Drug Application (ANDA) for Tha­lid­o­mide Capsules. The com­pany believes that it con­tin­ues to be on track to submit its ANDA for Tha­lid­o­mide Capsules by January 2014.

As part of its prod­uct devel­op­ment activities for Tha­lid­o­mide Capsules, Lannett commenced bio-equivalency studies in fasting and fed con­di­tions in …

Silver Spring, MD (Official Notice) - FDA is providing in­­for­ma­tion on the avail­a­bil­ity of doxorubicin hydro­chlo­ride liposome injection to supply the U.S. market.

Doxil® (doxorubicin hydrochloride liposome injection) is distributed by Janssen Products, LP and has been manu­fac­tured under contract by Ben Venue Laboratories, Inc. On September 25, 2013, Janssen notified health­care professionals of an inter­rup­tion of supply of Doxil resulting from manu­fac­tur­ing issues at Ben Venue Laboratories. On October 3, 2013, Ben Venue Laboratories announced their plans to cease all manu­fac­tur­ing by the end of 2013.

Sun Pharma Global has con­firmed …

Accurate Prognosis and Molecular Subtyping is a Foundation of Personalized Medicine for Multiple Myeloma pa­tients

New York, NY (Press Release) - Signal Genetics LLC, a leading provider of molecular assays for Multiple Myeloma, has received a positive coverage de­ci­sion and in-network provider status from Arkansas Blue Cross Blue Shield for its MyPRS™ gene ex­pres­sion profiling assay. Little Rock-based Arkansas Blue Cross Blue Shield is part of the Blue Cross Blue Shield network, which serves more than 1 million members across the nation.

MyPRS™ is a molecular cancer assay per­formed on isolated plasma …