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Berlex, a U.S. affiliate of Schering AG, announced that the FDA has expanded the indication of Betaseron (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS.
The FDA approved AstraZeneca's Seroquel to treat depressive episodes from bipolar disorder, making it the only single medication approved to treat both depressive and manic episodes, the company said.
Schering-Plough announced that the FDA has approved Noxafil (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole.
SkinMedica announced that the FDA has approved the company's new drug application (NDA) for Desonate (desonide gel) 0.05 percent for treatment of mild to moderate atopic dermatitis.
Orexigen Therapeutics announced that Excalia, a combination of two centrally acting medications intended to provide and sustain clinically important weight loss, demonstrated significant weight loss in a six-month, double-blind, Phase IIa clinical study.
Eli Lilly has launched a major clinical trial evaluating Alimta (pemetrexed for injection) in extensive-stage small-cell lung cancer (SCLC), a devastating and rapidly spreading form of lung cancer.
Sepracor has presented data from a Phase III pivotal trial of Brovana (arformoterol tartrate) Inhalation Solution at the annual meeting of the American College of Chest Physicians.
Abbott Laboratories has announced results from a study showing Humira (adalimumab) induced significantly higher rates of clinical remission compared with placebo in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab therapy.