FDA has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.
Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s marketing authorization application for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada (emtricitabine and tenofovir disoproxil (as fumarate)). The CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the European Union (EU).
Professor Wilhelm Einar Stellan Hjertén of the Institute of Biochemistry, Uppsala University in Sweden, is this year's winner of the Arnold O. Beckman Medal and Award, which recognizes outstanding contributions to the field of electrodriven separation techniques and was presented at the 29th International MicroScale Bioseparations Symposium.
Q Laboratories has named Michelle Kelly microbiology laboratory supervisor of the company’s pharmaceutical division. Michelle has been a member of the Q Laboratories’ staff since 2004, serving as Microbiology Lab Supervisor for more than five years. She will be responsible for all clients and samples for the pharmaceutical, dietary supplement, cosmetic, and health and beauty care industries. She will oversee training of analysts in pharmaceutical related methods and manage the day-to-day operations of the Pharmaceutical Microbiology Laboratory.
Recipharm’s solid-dose facility located in Fontaine, France, has been approved for supply of manufactured products to Japan’s pharmaceuticals market following a recent inspection by the PMDA, the Japanese drug agency. The product dossier was presented by an existing contract manufacturing customer, also securing regulatory approval for its supply to Japan.