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Finance Watch: Ayala Launches First Biopharma IPO In May

The cancer drug developer raised $55m. Also, Lyra raised $56m in the last of four biopharma IPOs in April, Biogen sold $3bn worth of debt, Oberland raised a $1.05bn fund and Praxis launched with more than $100m. 

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Scrip Asks… What Does 2020 Hold For Biopharma? Part 4: The Patient

From the general to the particular: drug developers are increasingly tailoring therapies to individuals. Driven by important advances in understanding biology as well as new tools to harness big data, industry participants expect significant progress in biopharma’s approach to the patient.

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US FDA's Stein Outlines Functions Of Rare Disease, Inborn Error Groups In New OND Division

Office of New Drugs director Peter Stein shed some light on how the newly established Division of Rare Diseases and Medical Genetics will operate following the completion of the OND reorganization, drawing mixed reactions from industry speakers.

Leadership FDA

US FDA's Stein To Sponsors: New Leadership From OND Reorganization Won't Change Your Development Plans

Office of New Drugs Director Peter Stein told sponsors during a panel discussion that they will be able to continue agreed upon development programs despite leadership changes arising from the OND reorganization; industry speakers excited, but also have some reservations, about the new OND.

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