The FDA has handed Mylan and Fujifilm Kyowa Kirin Biologics approval for their biosimilar of Humira (adalimumab), marking the agency’s sixth approval for a biosimilar of AbbVie’s blockbuster immunosuppressive drug. Read More

Amgen and Roche have settled their litigation related to Amgen’s biosimilars of Roche’s blockbuster cancer drugs Avastin and Herceptin. Read More

In a win for AbbVie, a preliminary ruling from a U.S. International Trade Commission (USITC) judge could lead to a 10-year ban on a competitor’s Botox treatment. Read More

Type 2 Diabetes drug metformin is the latest medicine to be recalled due to unacceptable levels of the probable human carcinogen NDMA (N-Nitrosodimethylamine). Read More

Moderna has tapped Spanish pharma company Laboratorios Farmacéuticos Rovi to conduct large-scale, commercial fill-finish manufacturing of its COVID-19 vaccine candidate in order to bolster international supply. Read More

More than 20 leading drugmakers have teamed up on a new program to develop innovative antibiotics in the coming decade to help curb the global threat of antibiotic-resistant infections. Read More

Gilead Sciences has begun testing an inhaled version of remdesivir that it hopes could be used to treat less severe COVID-19 cases. Read More

The FDA issued a warning letter to active pharmaceutical ingredient (API) manufacturer Vega Life Sciences for violations of good manufacturing practices (cGMP) at its facility in southern India. Read More