European regulators recommend approval of Orexigen’s obesity pill

(Reuters) – European regulators recommended the approval of Orexigen Therapeutics Inc’s diet pill, which could become the first prescription medicine for obesity to be approved in the European Union in nearly a decade. The drug, sold as Contrave by partner Takeda Pharmaceutical Co in the United States, will be marketed as Mysimba in Europe. The European Commission is expected to give its decision on the drug in early 2015, Orexigen said. The treatment, which won U.S. …
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Novo Nordisk gets positive opinion on Tresiba for children in Europe

COPENHAGEN (Reuters) – Drug maker Novo Nordisk said the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the use of its diabetes drug Tresiba for the treatment of children and adolescents. An European Commission approval of the label expansion means physicians in the European Union will be able to prescribe Tresiba to children with type 1 and type 2 diabetes, Denmark’s Novo Nordisk said in a statement on Friday. …
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Europe recommends approval for first stem-cell therapy

LONDON (Reuters) – European regulators have recommended approval of the first medicine containing stem cells to treat a rare condition caused by burns to the eye. The European Medicines Agency said on Friday that Holoclar, from privately held Italian company Chiesi, had been given a green light for moderate to severe limbal stem cell deficiency due to physical or chemical burns. Left untreated, the condition can result in blindness. Holoclar is a living tissue product made from a biopsy taken from a small undamaged area of the patient’s cornea and grown in the laboratory using cell culture. …
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Philippine health minister resigns over vaccine purchase

MANILA (Reuters) – Philippine President Benigno Aquino has accepted the resignation of his health minister over the purchase of pneumonia vaccines in 2012 which government investigators later questioned, a spokesman said on Friday. Health Secretary Enrique Ona, who has been on leave since October, submitted his letter of resignation on Thursday even before the completion of a government inquiry into four deals at his ministry. “The President has accepted his resignation effective today,” Herminio Coloma, the president’s press secretary, told reporters in a text message. …
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