Schering-Plough received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Temodal capsules for the treatment of malignant glioma.

The approval follows a priority review of the J-NDA submission, which was granted in September of 2005 in order to satisfy an unmet medical need in Japanese patients. Temodal, marketed as Temodar in the U.S., is approved in 77 countries. Temodal will become available once pricing is determined by the Japanese MHLW.

Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30% of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of high-grade gliomas. GBM is the most common and aggressive form of primary brain tumor. Approximately 2,500 patients are diagnosed with malignant glioma in Japan each year.

Merck's NDA for MK-0431A, an oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for review by the FDA. The company expects a decision on the NDA by the end of March 2007. The company is also filing for approval in countries outside the U.S.

MK-0431A is an investigational treatment for type 2 diabetes that combines the novel approach to controlling blood sugar of Januvia, an investigational DPP-4 inhibitor, with metformin, a widely-prescribed medication for type 2 diabetes, into a single tablet. DPP-4 inhibitors work by enhancing the body's own ability to lower blood sugar when it's elevated. The combination drug is designed to provide a treatment option for patients who need two or more oral agents to help control their blood sugar.

Abbott received FDA approval for Humira for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain and stiffness and also can be associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS can result in complete spinal fusion, causing extreme physical limitation and loss of quality of life.

Humira is also approved by the FDA to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently under way evaluating Humira in other autoimmune diseases. Humira received approval in the EU to treat patients with severe, active AS in June of this year.