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BioCryst Pharmaceuticals, Inc.

https://www.biocryst.com/

Latest From BioCryst Pharmaceuticals, Inc.

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

Finance Watch: Investors Remain Receptive To Biopharma, Health Care SPAC IPOs

Public Company Edition: 2020 started with two $200m-plus initial public offerings plus five health care-focused special purpose acquisition corporations IPOs. Also, a Pfizer initiative backs three public companies, Fate’s $432m offering led recent FOPOs and Biocon Biologics receives more investment. 

Financing Business Strategies

Immunocore Aims For $100m IPO After Immunotherapy Success

The UK biotech is set for a NASDAQ launch which could propel it to its first commercial launch by 2022.

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