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Amgen

Amgen breaks ground on next-generation biomanufacturing plant

Amgen breaks ground on next-generation biomanufacturing plant

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

FDA approves addition of positive overall survival data to Kyprolis label

FDA approves addition of positive overall survival data to Kyprolis label

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)

Novartis and Amgen announce FDA approval of Aimovig

Novartis and Amgen announce FDA approval of Aimovig

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

Amgen’s Repatha OK’d to help prevent heart attack, stroke

Amgen’s Repatha OK’d to help prevent heart attack, stroke

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.

Amgen CEO elected as PhRMA chairman

Amgen CEO elected as PhRMA chairman

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

APhA brings pharmacy students to the Hill

APhA brings pharmacy students to the Hill

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

Sandoz launches Zarxio, the nation’s first biosimilar

Sandoz launches Zarxio, the nation’s first biosimilar

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