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Centocor announced that the FDA has approved Remicade (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Sanofi-aventis announced that the FDA has approved Allegra (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients 2 to 11 years of age and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age.
Novartis' Gleevec (imatinib mesylate) has received FDA approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders, according to Novartis.
Shire has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of Elaprase for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II).
GW Pharmaceuticals and Bayer HealthCare have announced that GW has submitted an application in Canada for Sativex to seek approval for a new indication in the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.
AstraZeneca has submitted filings to European and Canadian authorities for the approval of the sustained-release (SR) once-daily formulation of Seroquel for the treatment of patients with schizophrenia.
Array BioPharma has announced that its first-in-class MEK inhibitor for the treatment of inflammatory diseases, ARRY-438162, has met its primary objectives in a single-ascending-dose clinical study involving 20 healthy volunteers.
GlaxoSmithKline (GSK) has released new Phase III data that demonstrate significantly better immune responses in the age range 65 and above when vaccinated with GSK's new-generation (adjuvanted) seasonal flu vaccine compared with a traditional seasonal flu vaccine.