Tag Archive for: Catalent

The deal was announced in February and Novo Nordisk Foundation has since refiled its application to the U.S. FTC seeking regulatory approval for it.

The European Medicines Agency is investigating the potential impacts that Novo Holdings’ $16.5 billion acquisition of contract manufacturing giant Catalent will have on drug supply, according to reporting Wednesday by Reuters.

“We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,“ said Lars Fruergaard Jørgensen, president and chief executive officer at Novo Nordisk.

Novo depends upon a number of companies to help produce Wegovy, but it has released scant details on its supply chain for the weight-loss medicine and its diabetes drug Ozempic containing the same active ingredient.

Contract drug maker Catalent Inc. said on Tuesday it had added four new directors to its board and will conduct a strategic review after reaching a settlement with activist investor Elliott Investment Management.

Catalent’s plant in Bloomington, Indiana, will fill injection pens for Novo Nordisk’s weight-loss drug Wegovy as part of the two companies’ expanded supply agreement, two sources familiar with the matter told Reuters.

Regeneron and partner Bayer are betting on longer intervals between injections through the higher dose to win over patients.

The factory that fills the self-injection pens for booming weight-loss drug Wegovy has repeatedly breached U.S. sterile-safety rules in recent years and staff have failed to perform required quality checks, according to a Reuters review of regulatory documents.

The contract manufacturer has been facing challenges at three of its major production sites, which may affect its third and fourth-quarter revenue due to a slower-than-expected ramp up in production capacity.

The company said it experienced “productivity issues” at its gene therapy manufacturing site and faced similar issues at its drug product and drug substance manufacturing facilities.