The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Source: Drug Industry Daily

Missouri’s Supreme Court upheld a $38 million verdict against Abbott Laboratories over claims its epilepsy drug Depakote caused birth defects. Source: Drug Industry Daily

Recent action from a state legislature, as well as objections from industry groups, suggest the FDA should narrow its guidance for off-label claims, according to two prominent labeling attorneys. Source:…

The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality. Source: Drug Industry Daily

The FDA approved the first U.S. biosimilar for the treatment of cancer, Amgen’s Mvasi, a biosimilar of the blockbuster Avastin. Source: Drug Industry Daily

A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to…

Drugs to treat heart disease are taking a shrinking slice of the FDA approval pie, a Tufts University study says. Source: Drug Industry Daily

Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs. Source: Drug Industry Daily

Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Source: Drug Industry Daily

A federal court invalidated five Mallinckrodt Pharmaceuticals patents on its Inomax respiratory treatment system in response to the company’s own lawsuit against Praxair. Source: Drug Industry Daily