By: Sten Stovall and Jennifer Corbett Dooren
LONDON—Europe's drug regulator Friday said it is reviewing the "benefits and risks" of Novartis AG's multiple-sclerosis drug Gilenya and recommended doctors closely monitor the hearts of patients after they have been given the first dose of the drug.
Approximately One-Third of MS Patients Experiencing Relapses Do Not Adequately Respond to Traditional Corticosteroid Therapy
On October 21 at the 5th Joint Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), results were presented from a survey conducted by NARCOMS which found that about one-third of patients experiencing MS relapses do not adequately respond to corticosteroid treatment. The survey included over 2,000 patients with MS who had experienced relapses and were treated with either intravenous (IV) or oral corticosteroids.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that more than 30 scientific presentations on the company’s multiple sclerosis (MS) portfolio, including the market-leading treatment Copaxone® and the late-stage oral therapy laquinimod, will be featured during the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS AND ACTRIMS).
FDA Accepts Filing of New Drug Application (NDA) for Yaupon's Proprietary Gel Formulation of Mechlorethamine Hydrochloride
Yaupon Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its propriety gel formulation of mechlorethamine hydrochloride (mechlorethamine). Yaupon is seeking U.S. marketing approval of its mechlorethamine gel for the treatment of early stage (stages I-IIA) mycosis fungoides, the most common type of Cutaneous T-Cell Lymphoma (CTCL).
British scientists conducting early-stage research have found that a potential new drug from GlaxoSmithKline could treat mixed-lineage leukemia(MLL) -- the most common form of leukemia in babies.
In a study published in the journal Nature, scientists from the British drugmaker collaborating with the charity Cancer Research UK (CRUK) and Cellzome AG found that the experimental drug, called I-BET151, mimics a chemical tag which is key to preventing the process of activating the leukemia genes.
By Cole Petrochko
The FDA has approved the blood disorder drug eculizumab (Soliris) for treatment of atypical Hemolytic Uremic Syndrome (aHUS), a rare pediatric blood disease that can cause renal failure.
The new indication marks the orphan drug's second approval for a rare blood disorder. Eculizumab's first approval was for treatment of paroxysmal nocturnal hemoglobinuria.
Shire PLC won US marketing approval for Firazyr, the first self-injectable drug to treat attacks of a rare genetic swelling disease, giving it an edge over products by CSL Ltd. and Dyax Inc.
Firazyr was approved for acute attacks of hereditary angioedema in people aged 18 years and older, the Food and Drug Administration said in a statement yesterday. The therapy has been approved for use in Europe since 2008.
The Food and Drug Administration has approved two three-month strengths of Abbott Laboratories’ Lupron Depot-PED to treat children with central precocious puberty, a condition that causes young children to start puberty too soon.
Lupron Depot-PED works by suppressing the level of hormones that cause puberty, helping delay premature puberty in girls under 8 and boys under 9 until a more appropriate time in the child’s life. With the approval of a three-month formulation, children with CPP now may receive their treatment four times per year instead of 12.
By Alaric Dearment
The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.
Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.
By Anna Yukhananov and Ransdell Pierson
An experimental stroke preventer from Bayer and Johnson & Johnson is likely to win a recommendation from U.S. health advisers next week, but not without concern over risks seen when patients come off the drug.
A key issue for the Food and Drug Administration advisers may be the so-called rebound effect of the medicine Xarelto. When patients stopped taking it and resumed older drug warfarin, higher risk of stroke was seen in trials.