In this week’s news, NASH guidelines from the FDA, EMA bids to retain staff, WHO looks at gene editing, and more…
EMA bids to convince staff to make the move to Amsterdam
The EMA has offered staff free holidays in Amsterdam in a bid to retain more of its workforce as it prepares to move from London to the Dutch capital next year.
The agency – which is relocating as a result of the UK’s decision to withdraw from the European Union – has also offered staff guided tours of the city and Dutch language lessons according to a report by Politico.
EMA spokesman Noël Wathion told the publication “It’s a short visit but nevertheless it shows you what the Netherlands is like to live in.”
The EMA has been concerned about its ability to retain staff tasked with oversight of the drug industry for some time. In August the agency warned it could lose up to 30% of employees and predicted that drug reviews would be delayed.
The current expectation is that around 24% of the EMA’s 900 staff will leave.
US FDA sets new trial guide to help developers take bite out of NASH
The US FDA has published guidelines to encourage innovative trial designs for fatty liver disease treatments.
The agency published the guideline citing the lack of drugs and the prevalence of the disease – officially known as noncirrhotic nonalcoholic steatohepatitis (NASH) – in liver fibrosis patients – as the prompt.
It wrote, “Currently, there are no approved drugs for the treatment of NASH. Given the high prevalence of NASH, the associated morbidity, the growing burden of end-stage liver disease, and the limited availability of livers for organ transplantation, FDA believes that identifying therapies that will slow the progress or, halt, or reverse NASH and NAFLD will address an unmet medical need.”
One of the problems facing NASH drug developers is that there is no way to identify which non-alcoholic fatty liver (NAFL) disease sufferers will progress to the condition.
To address this, the FDA advocates the development of biomarkers. It also sets out recommendations for preclinical and clinical development as well as trial design and endpoint selection.
Read more at RAPS.
US FDA sets out to help firms whose drugs it rejects
In other new guidance, the US FDA has set out how companies whose drugs it rejects should respond.
The “post-complete response letter” guideline was issued last week. It covers how developers can gain from further interaction with the agency.
The Agency wrote, “This guidance is intended to provide procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022.”
Also in the news
A combination of sunlight treatment and exposure to bacteria-targeting viruses has been proposed as a way of preventing the spread of anti-microbial resistance (EMA). Read more in the Economist.
The practice of ‘insourcing’ is assessed in a blog post in Science. Writer Derek Lowe looks at how Eli Lilly and AMRI have worked together in recent years.
The UK Government says policies it has introduced are helping firms developing and manufacturing vaccines for diseases like Ebola and Lassa fever.
The WHO is looking to develop standards covering the use of gene editing techniques. Read Reuters story.
UCB and IQVIA have announced a multimillion pound investment plan. Read the full story at Pharmaphorum.