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Alexza Pharmaceuticals (NASDAQ:ALXA) and Grupo Ferrer Internacional said Friday that the Committee for Medicinal Products for Human Useof the European Medicines Agency has adopted a positive opinion recommending that Adasuve (Staccato loxapine) be allowed European Union centralized marketing authorization. The Committee recommends that the drug be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients suffering from schizophrenia or bipolar disorder.
DUSA Pharmaceuticals (NASDAQ:DUSA) announces the preliminary results of a Phase 2 clinical trial inquiring into the use of the Levulan Kerastick linked with BLU-U blue light illumination for the treatment of actinic keratoses of the face and scalp when utilizing short drug incubation. The evaluation showed that treatment with Levulan Kerastick, following an incubation for one, two or three hours, resulted in a statistically significant number of patients with complete lesion clearance and a statistically significant lowering of AK lesion count, when contrasted with treatment with vehicle 12 weeks post treatment.
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The FDA on Friday approved GlaxoSmithKline’s (NYSE:GSK) raxibacumab injection to treat inhalational anthrax, which is a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Further, Raxibacumab is cleared to prevent inhalational anthrax when alternative therapies are not available or not appropriate. The durg is a monoclonal antibody that neutralizes toxins produced by B. anthracis that can cause massive and irreversible tissue injury and death.
ARIAD Pharmaceuticals (NASDAQ:ARIA) said Friday that following a priority evaluation, the FDA has allowed accelerated approval of Iclusig” (ponatinib) for the treatment of adult patients suffering from chronic, accelerated or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior TKI therapy.
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