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Swedish Orphan Biovitrum AB

https://www.sobi.com/

Latest From Swedish Orphan Biovitrum AB

GSK’s Ojjaara Scores Myelofibrosis Nod After Round-The-World Journey

The US FDA approved the JAK inhibitor momelotinib for myelofibrosis with anemia, with an analyst forecasting peak sales of more than $425m.

Approvals Cancer

Japan Sets Luxturna, Other New Prices While Cutting Selected Fast Growers

Six new drugs including Luxturna will be price-listed in Japan on 30 August, with the Novartis gene therapy set to become the second-most expensive therapeutic product in the country. Behind another round of market expansion-related price cuts for selected drugs, discussions on possible changes to the repricing system are ongoing.

Japan Regenerative Medicine

Finance Watch: Mallinckrodt Bankruptcy Enables Debt, Opioid Pact Payouts

Public Company Edition: Mallinckrodt entered into a restructuring support agreement with most of its debt holders and will de-list. Also, Aprinoia no longer plans to go public in a SPAC merger and Novartis, Agenus and Aravive revealed job cuts.

Financing Restructuring

US FDA’s Breakthrough Designation Pace Slows, But Topics Broaden

The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.

US FDA Performance Tracker Review Pathway
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    • Akinion Pharmaceuticals AB
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