Albireo Pharma, Inc.
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Latest From Albireo Pharma, Inc.
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.
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.
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.
NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s elafibranor, and Albireo thinks IBAT inhibition offers promise in NASH.
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