Pharma News

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.

Researchers have identified how two proteins control the growth of the heart and its adaptation to high blood pressure that can help design new strategies to treat heart failure caused by excessive growth of the heart.

There are 60 genetic disorders that affect skin and nervous system in humans, researchers report.

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A team of Swedish researchers has used cells from cow knee joints to grow new cartilage tissue in laboratory that can help treat degenerative joint disease like osteoarthritis (OA).

In what could be termed as “silver bullet” for Ebola viruses, a team of researchers has isolated human antibodies from Ebola survivors which can neutralise multiple species of the virus that has killed more than 11,000 people in West Africa in the past two years.

AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

CymaBay Therapeutics, Inc, a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, announced that it has successfully concluded its end-of-phase 2 meeting discussions with the U.S. Food and Drug Administration (FDA) on the Phase 3 development program for arhalofenate.