BURLINGAME, Calif. — Ten of the world’s leading biopharmaceutical companies announced the formation of a new non-profit corporation, Accumulus Synergy, which is intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission. Accumulus Synergy was formed on July 13, 2020, to develop a
THOUSAND OAKS, Calif. — Amgen announced the groundbreaking of its new next-generation biomanufacturing plant that will be constructed at its West Greenwich, R.I. campus. The new plant is the first-of-its-kind in the U.S. and will use Amgen’s proven next-generation biomanufacturing capabilities to manufacture products for the U.S. and global markets. “Biologics manufacturing is a complex science and has
THOUSAND OAKS, Calif. — Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 Aspire trial to the U.S. Prescribing Information for Kyprolis (carfilzomib). Data added to the label showed that Kyprolis, lenalidomide and dexamethasone (KRd)
Basel, SWITZERLAND – Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig (erenumab) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to
THOUSAND OAKS, Calif. — After a priority review of its supplemental Biologics License Application, Amgen has gained approval from the Food and Drug Administration for the cardiovascular drug Repatha. Amgen said Repatha (evolocumab 140 mg/ml injection) is the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.
WASHINGTON — Pharmaceutical Research and Manufacturers of America (PhRMA) has named Amgen Inc. chairman and chief executive officer Robert Bradway as chairman-elect. Bradway will succeed Joaquin Duato, executive vice president and worldwide chairman of pharmaceuticals at Johnson & Johnson, as PhRMA chairman in February 2018. Previously, Bradway served as board treasurer for PhRMA. Sanofi CEO
WASHINGTON — Over the weekend, the American Pharmacists Association (APhA) gave pharmacy students an opportunity for their voices to be heard on Capitol Hill. The APhA Academy of Student Pharmacists (APhA-ASP), supported by Rite Aid, Cardinal Health and Amgen, hosted leadership and professional development programming in Washington, D.C., for 240 pharmacy students. Running Friday to
NEW YORK — Sandoz has inaugurated a new era in medicine with the release of Zarxio, the first biosimilar of a biologic drug approved in the United States. The Novartis subsidiary said Thursday that Zarxio — a biosimilar of Amgen Corp.’s oncology drug Neupogen, which boosts white blood cells — would broaden access to an
