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Prosensa Holding N.V

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Latest From Prosensa Holding N.V

BioFire COVID-19 Test De Novo Clearance Paves Way For Other EUAs To Stay On The Market

BioFire’s test detects a range of respiratory and bacterial infections, including SARS-CoV-2. Its clearance is the first example of how other products with EUAs can stay on the market after the pandemic.

Coronavirus COVID-19 Diagnostics

Interview: Mallinckrodt Deal Golden For Silence Therapeutics

The gene silencing specialist has signed a collaboration that CEO David Horn Solomon tells Scrip will help push Silence up among its peers in the RNAi space.

Companies Deals

Real-World Data Boost Santhera's Latest DMD Filing, And The Markets Agree

Despite being knocked back twice, Santhera CEO Thomas Meier is still confident Raxone has a place as a Duchenne muscular dystrophy therapy, and believes new long-term data will strengthen its third application to the EU in the coming months.

Rare Diseases Clinical Trials

FDA’s DMD Decisions: Glass Two-Thirds Full?

The outcome of an US advisory committee review of PTC’s ataluren was not surprising. That is bad news for PTC’s prospects of launching the drug in the near term – but given the recent history of the DMD class, it is probably good news for biopharma companies overall as a sign that FDA's neurology group is moving forward effectively.

Advisory Committees Drug Approval Standards
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