Regulatory
Esperion announced that the company has successfully completed important and key global marketing applications including the submission of two New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration.
Recipharm, the contract development and manufacturing organisation, has achieved the new ISO 45001 certification at its Wasserburg facility in Germany.
GENFIT, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, announces the filing of its 2018 Registration Document with the Autorité des marchés financiers.
NOXXON Pharma N.V. announced that it has filed the clinical trial application (CTA) with the Federal Institute for Drugs and Medical Devices, to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
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.
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