Italy’s medicines agency, AIFA, says its initial experience of dealing with the COVID-19 outbreak was difficult as opportunities to run large informative trials in the early days were missed.
Italy Opens Up On Trial Woes In A Pandemic
Italian medicines agency chief Nicola Magrini recounts the problems AIFA faced and the lessons it learned through its work at the height of the coronavirus outbreak in Italy.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
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Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.
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The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.