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☆ FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
▼ + stars: | 2022-11-23 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +2 min

CNN —The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the world. In a recent cost-effectiveness analysis of the drug, weighing health benefits against offset costs, ICER suggested that a fair price for the drug to be between $2.93 million and $2.96 million. According to an analysis by GoodRx, the most expensive drug in the US previously was Zolgensma, which was approved by the FDA in 2019 to treat spinal muscular atrophy and priced at $2.1 million for a course of treatment. FDA approved Hemgenix based on safety and effectiveness evaluated in two studies of about 60 adult men.

Nov 22 (Reuters) - Australian drugmaker CSL Ltd (CSL.AX) on Tuesday set the list price of its one-time gene therapy for hemophilia B at $3.5 million, making it the world's most expensive treatment, following its approval by the U.S. health regulator. The first gene therapy for the rare genetic blood clotting disorder offers a long-term solution for patients as against current treatments from Biogen (BIIB.O), Pfizer (PFE.N) and others that focus on regular infusions. The gene therapy consists of an engineered virus carrying a gene expressed in the liver to produce clotting factor IX. While Zynteglo was priced at $2.8 million, Skysona had a wholesale cost of $3.0 million. CSL shares were up 1% at A$300.62 on the Australian stock exchange, while UniQure stock edged up 0.9% in extended trading.

☆ U.S. flu hospitalizations highest in 10 years, officials say
▼ + stars: | 2022-11-04 | by ( ) www.reuters.com time to read: +1 min

The rising flu cases come alongside pressure on hospitals from respiratory syncytial virus (RSV) and COVID cases, officials said, urging people to get vaccinated and offering to assist states that may need additional support. There have been 5 million fewer doses of influenza vaccine administered to U.S. adults so far this year compared to this time last year, officials said. Flu vaccine uptake is about the same for children this year but overall is down 6% compared to before the COVID pandemic began in 2020. About 5% fewer pregnant people have received flu shots so far this season, which officials say is especially worrisome because the vaccine protects both the expecting mother and her baby, officials added. U.S. flu shots are made by Sanofi SA (SASY.PA), GSK (GSK.L) and Seqirus, a unit of CSL Ltd (CSL.AX)Reporting by Julie Steenhuysen and Susan Heavey; Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Австралия остановила испытания вакцины от COVID-19 из-за ложноположительных тестов на ВИЧ
▼ + stars: | 2020-12-11 | by ( Mld Media Srl | ) noi.md time to read: +1 min

«Однако после консультации с правительством Австралии CSL не будет продвигать вакцину-кандидат к клиническим испытаниям фазы 2/3», —указано в заявлении учреждений. Участники испытания вакцины были заранее проинформированы о возможности частичного иммунного ответа, но появление ложно-положительных тестов на ВИЧ у некоторых из них стало неожиданностью, говорится в заявлении. По его словам, компания согласилась произвести еще 20 млн доз. О том, что Австралия закупит вакцины у трех фармкомпаний, Моррисон сообщил в начале ноября. Согласно договоренностям, на континент поставят 50 млн доз препаратов в 2021 году.

Persons: Эндрю Нэш, Скотт Моррисон, Моррисон Organizations: Университет Квинсленда Locations: Австралия

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