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BioCryst Pharmaceuticals, Inc.

https://www.biocryst.com/

Latest From BioCryst Pharmaceuticals, Inc.

Scrip Asks…What Does 2021 Hold For Biopharma? Part 2: COVID-19 Shock Waves And Silver Linings

Executives expect the changes wrought by necessity in the face of a global pandemic to have lasting effects, both positive and negative, on the biopharma sector. Here they share their predictions for the coming year.

Coronavirus COVID-19 Research and Development Strategies

Pandemic Leaves Medtech With $500bn In M&A Firepower

EY’s M&A Firepower report predicts very active M&A activity for medtechs in 2021, driven by diagnostics and digital health, but with some headwinds remaining.

Business Strategies Commercial

Japan Regulators Kept On Track Despite Pandemic

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

Japan Regulation

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Review Pathway Post Market Regulation & Studies
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