FDAnews Drug Daily Bulletin

The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011.

Sovereign Pharmaceuticals’ blend uniformity tests and batch failure investigations fall short of the company’s written procedures, an FDA Form 483 states.

A district court judge has largely sided with Jazz Pharmaceuticals’ definitions for patents on its narcolepsy drug Xyrem, and the outcome looks like a “clear win” in Jazz’s legal struggle to prevent generic competition from Roxane Laboratories, one analyst says.

AstraZeneca Pharmaceuticals agreed to pay $11 million to settle claims by a proposed class of indirect purchasers of hypertension drug Toprol-XL that the drugmaker used sham patent litigation to prolong a monopoly on the drug by delaying generic versions.

Alnylam Pharmaceuticals said a U.S. federal court has ruled that it could sue Canada’s Tekmira Pharmaceuticals for infringing patents on lipid nanoparticle technology exclusively licensed to Alnylam.

The U.S. Food and Drug Administration approved a risk-mitigation plan for a specific class of organ-transplant drugs to warn women about the risk of miscarriages and birth defects.

Johnson & Johnson won its challenge to two Abbott Laboratories patents on antibodies that help curb the effects of the painful skin disease psoriasis.

Partners Biogen Idec and Swedish Orphan Biovitrum reported positive data from a Phase III study evaluating the long-lasting recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

The first clinical study of a drug to treat progeria, a fatal disease that causes early-onset aging in children, was published Monday in the Proceedings of the National Academy of Sciences.