Tag Archive for: Prolia

Under the agreement, Dr. Reddy’s gets exclusive commercialization rights in the United States as well as semi-exclusive rights in Europe and United Kingdom, and Alvotech will be responsible for development and manufacture of the product.

The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.

With the settlement of a big acquisition behind them and a strong portfolio of therapeutics that continues to expand, hopes for smooth sailing are on the horizon.

Amgen Inc. sued Novartis AG’s Sandoz in New Jersey federal court Monday, accusing Sandoz’s proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents.

The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).

Amgen is equipped with a broad and diverse product portfolio, commercial capabilities, and levers for delivering mid-single digit revenue growth over this decade.