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  • Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that  we received the letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer. The work underscoring the new designation was conducted by Cellceutix scientists in collaboration with pancreatic cancer specialists at a world filed grant application.

  • Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin a clinical trial of Hydrocodone DETERx®, an abuse-deterrent, extended-release analgesic for the treatment of chronic pain. This proof of concept clinical trial is intended to evaluate the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx.

  • Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

  • The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

  • Drugs Controller General India (DCGI) took strict measures on Roche's Avastin (Bevacizumab Injection) after some reports on loss of visions. It is noted that opthalmic injection of Avastin leads to blindness in some patients which is not approved for intra-vitrieal use in India as per DCGI.

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