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US shutdown

This page shows the latest US shutdown news and features for those working in and with pharma, biotech and healthcare.

FDA starts review of Biogen’s Tecfidera follow-up for MS

FDA starts review of Biogen’s Tecfidera follow-up for MS

It was initally submitted towards the end of 2018 but had been delayed by US gov shutdown. ... BIIB098 (diroximel fumarate) was actually submitted for approval in the US towards the end of 2018 but appears to have been caught up in the US government

Latest news

  • Alector kicks off next wave of biotech IPOs Alector kicks off next wave of biotech IPOs

    US biotech raising money again. The US government shutdown of 35 days had deterred new IPOs in biotech, but market launches have now resumed with immune-neurology specialists Alector. ... Its plans had also been disrupted by the government shutdown, but

  • Rising economic risk casts shadow on Davos meeting Rising economic risk casts shadow on Davos meeting

    government shutdown is also pouring cold water on the economy, says the IMF. ... That list includes US president Donald Trump who said the government shutdown prevented him and the entire US delegation from attending, as well as UK prime minister Theresa

  • FDA expecting boom in cell and gene therapies FDA expecting boom in cell and gene therapies

    by the US government shutdown, now in its fourth week. ... The last couple of years have already seen the approval of the first gene therapy in the US – Spark Therapeutics’ Luxturna for a rare disease – as well as new cell therapies

  • FDA moves into crisis mode as shutdown drags on FDA moves into crisis mode as shutdown drags on

    New drug appraisals already being affected. As the US government shutdown enters a record fourth week, FDA Commissioner Scott Gottlieb says the agency is now facing one of the most significant ... activities” and could result in slower approvals for

  • US government shutdown leaves FDA running on empty US government shutdown leaves FDA running on empty

    Funding row means shutdown could break 21 day record. The ongoing US government shutdown has left the FDA with just a month of funding left, because it can’t accept any ... During that shutdown around 800, 000 federal employees were furloughed. The

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Latest Intelligence

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    However the company, like many others, is at the mercy of the US government shutdown, which means many FDA staff are on unpaid leave, and threatens drug approval timelines if it ... Its early US take-up is encouraging, according to Shire, with Q3 sales

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