WILMINGTON, Del., Oct. 10 — AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR(R) (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar [...]

   WILMINGTON, Del., Sept. 22 – AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009. AstraZeneca has been working with the FDA in the investigation of the safety and effectiveness [...]

   PHILADELPHIA, Aug. 19 – The relationship between medication adherence and income level may contribute to the disparities in health observed across socioeconomic groups, according to a recent study published in the Journal of General Internal Medicine. The study, funded by GlaxoSmithKline (NYSE: GSK), investigated whether individuals who reside in low-income areas are more strongly influenced [...]

RIDGEFIELD, Conn., June 24 — Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted approval of Aptivus(R) (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1. The oral solution formulation, which is a new dosage form of APTIVUS, was also [...]

SAN ANTONIO, May 20 - Mission Pharmacal announced the launch of Ferralet(R) 90, a new prescription oral iron supplement for treatment of iron deficiency anemia (IDA) that is responsive to oral iron therapy. IDA is a depletion of stored iron that prevents maturation of red blood cells. Ferralet 90 contains 90 mg of carbonyl iron as [...]

BASINGSTOKE, England and PHILADELPHIA, April 23 – Shire plc (LSE: SHP) (NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE(TM) (lisdexamfetamine dimesylate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. VYVANSE, introduced in July 2007 for the [...]

REHOVOT, Israel, March 4 - D-Pharm announced today that it has held its Pre-IND (Investigational New Drug) meeting with the FDA to discuss the forthcoming IND submission for DP-b99, a novel drug to aid recovery following acute stroke. The Pre-IND meeting focused on the proposed plans for the Phase III clinical program and the discussion included [...]

WILMINGTON, Del., Feb. 29 - AstraZeneca (NYSE: AZN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult [...]

CHESHIRE, Conn., Jan. 7 - Alexion Pharmaceuticals, Inc. (the “Company,” Nasdaq: ALXN) today announced that it has commenced dosing in the AEGIS study, a single registration study to evaluate the safety, efficacy, and pharmacology of Soliris(R) (eculizumab) as a treatment for Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH). When fully enrolled, the open-label study, authorized by [...]