FDAnews Drug Daily Bulletin

The House Wednesday overwhelmingly approved reauthorizing the Prescription Drug User Fee Act (PDUFA), sending it on to the Senate with a voice vote.

Drug and medical device companies and some local government officials are urging Health Canada to expand its summary basis of decision (SBD) initiative so product approval reports are published more quickly and on a wider range of products.

Drugmakers can help secure the global supply chain from counterfeits and cargo theft by mapping their network of suppliers to better assess their risks and prioritize mitigation, industry groups say.

The South African Department of Health has persuaded pharmaceutical company Roche to halve the price of its cancer drug rituximab, opening the way for the government to provide it to more patients.

Merck is in talks to acquire Indian active pharmaceutical ingredients maker Micro Labs.

South Carolina Gov. Nikki Haley has vetoed a bill allowing the state’s public health agency to provide information on and access to a free vaccine that prevents a sexually transmitted, cancer-causing virus.

Johnson & Johnson and the Justice Department are close to settling a protracted investigation into the company’s promotion of the antipsychotic Risperdal, for what would be one of the highest sums to date in a drug-marketing case, said people familiar with the matter.

Public health advocates accused Merck of improperly marketing an over-the-counter allergy medicine directly to children using animated characters from the movie “Madagascar 3: Europe’s Most Wanted.”

The Comisión para Promover la Competencia has begun an administrative process to fine five pharmaceutical companies in Costa Rica for misleading practices.