The FDA has approved Novartis’ and Amgen’s Aimovig (erenumab), a drug used to prevent migraines in adults by blocking the calcitonin gene-related peptide receptor. Novartis identifies Aimovig as a potential blockbuster drug. Read More

The UK government has outlined recommendations for pharmaceutical regulation and trade in the UK post the UK’s withdrawal from the European Union. These include the UK remaining part of the European Medicines Agency and the International Council on Harmonization (ICH) and continuing industry practices such as GMP and GDP. Read More

Astellas Pharma plans to restructure its operations in Japan, which includes the discontinuation and divestment of certain subsidiaries as well as the introduction of an early-retirement incentive program for which 600 applicants are estimated to apply. Read More

The FDA has issued a complete response letter over manufacturing issues to Evolus, a medical-aesthetics company, relating to its biologics license application for DWP-450 (prabotulinumtoxinA) for treating glabellar lines (frown lines). It is a potential competitor to Allergan’s Botox (onabotulinumtoxinA), which had 2017 sales of $3.16 billion. Read More

Novartis’ AveXis, a clinical-stage gene-therapy company, plans to invest $55 million to build a new manufacturing center in Research Triangle Park, Durham County, North Carolina. Novartis acquired AveXis for $8.7 billion in May. Read More

Gilead Sciences has opened a new EUR 9.5 million ($11-million) manufacturing facility quality-control (QC) laboratory in Carrigtwohill, County Cork, Ireland. The site produces Gilead’s hepatitis and HIV drugs and is responsible for a quarter of Gilead’s total production of drugs in tablet form. Read More

Novo Nordisk has partnered with the University of California San Francisco for technology for generating GMP human embryonic stem-cell lines to support Novo Nordisk’s increased focus on stem cell-based therapies and expand its focus on Type I diabetes into other chronic diseases. Read More

AstraZeneca has opened a new research and development (R&D) site in South San Francisco, California to bring together five of its San Francisco Bay Area sites into one location. AstraZeneca says more than 350 employees in nearby R&D facilities will move to the new location. Read More

Vectalys, a Toulouse, France-based biotechnology company specializing in lentiviral manufacturing services, and Auriga Partners, a venture-capital firm, have partnered to form FlashCell, a new gene-therapy company specialized in developing RNA carriers for therapeutic applications. Read More

Fortune released its annual list of the Fortune 500 companies, which ranks US-based companies with the largest revenues. This special feature from DCAT Value Chain Insights  examines how pharmaceutical companies and suppliers scored in the 2017 rankings . Read More