Regulatory
Pyoderma Gangraenosum is a debilitating, rare autoimmune disease marked by large, painful ulcers
BioSpace gathered together a roundup of global biopharma news from the past week. Bayer and Orion Corporation, Themis Bioscience, Axonics Modulation Technologies, and more are mentioned in this edition.
Shares of Adamis Pharmaceuticals are down nearly 5 percent this morning after the company announced late Tuesday that the U.S. Food and Drug Administration rejected its sublingual tadalafil product for erectile dysfunction, an alternative to the blockbuster Cialis.
FDA Commissioner Scott Gottlieb said the agency has changed its approach to the opioid crisis and will take a more aggressive approach on regulatory actions.
Shares of Karyopharm Therapeutics are crashing again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.
Roche’s Flatiron Health and the U.S. Food and Drug Administration’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement.
The FDA noted some concerns over the drug’s safety profile. Treatment with selinexor is associated with significant toxicity, the agency noted in its materials.
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
Two-year follow-up data shows 100 percent overall survival and 100 percent event free survival in comparison to a historical standard of care from a historical control group.
AbbVie announced that they have received approval for an additional indication of HUMIRA, a fully human anti-TNF-alpha monoclonal antibody, for the treatment of hidradenitis suppurativa.
PRESS RELEASES