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Horizon Therapeutics PLC

www.horizonpharma.com

Latest From Horizon Therapeutics PLC

Finance Watch: Panic Over FDA Commissioner's Resignation Was Short-Lived, Though IPOs Still Languish

Public Company Edition: Biotech stocks sank when US FDA Commissioner Scott Gottlieb announced his departure, but have nearly recovered to pre-resignation levels, except for newly public firms. Also, Biohaven's raises cash for PRV purchase and Endo issues $1.5bn in new debt.

Deals Financing

Horizon Pharma Sees Mid-2019 BLA For Tepro After Solid Phase III TED Data

Horizon Pharma is on track to file its top pipeline asset for regulatory approval this year after its Phase III confirmatory trial evaluating teprotumumab for the treatment of active thyroid eye disease met primary and secondary endpoints.

Ophthalmic Clinical Trials

Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

Drug Review Approvals

Four Drugs Set For EU Approval, EMA Holds Fire On Pacritinib

The European Medicines Agency this week recommended marketing approval for four medicines, including a drug for use in countries outside the EU.

Europe Approvals
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