Although they’re the stuff of science, statistics too often lack the power to move us. After all, they’re just numbers. So when companies like Dendreon Corp. and Seattle Genetics Inc. price their cancer treatments at nearly $100,000 or more, we may arch our eyebrows, but we don’t really think about the impact those prices will have on the individual faces and names behind the numbers. Instead, we wonder, as reported in BioWorld Today, why more patients don’t take advantage of promising drugs like Dendreon’s Provenge. Unlike statistics, faces and names have stories that can bring us to tears, that make...

WASHINGTON – In one of the largest forfeitures in U.S. history, Google Inc. agreed to pay $500 million for allowing online Canadian pharmacies to place advertisements through its AdWords program to target U.S. consumers, resulting in the illegal importation of prescription drugs.

Shire Human Genetic Therapies (HGT) is getting social as it launches its newly approved Firazyr, a self-administered injectable treatment for acute attacks of hereditary angioedema (HAE) in adults.

WASHINGTON – Orphan drug rules intended to encourage the development of treatments for rare diseases are creating an uneven playing field for follow-on biologics and personalized medicine.

Free speech. Most of us take it for granted. Unless you’re a drug company, that is. Since the FDA doesn’t trust biopharma when it comes to drug promotion, the agency believes that, as the watchdog of public health, it’s justified in curtailing drugmakers’ First Amendment rights. The FDA has put teeth to its leash on speech by issuing warning letters, which can block pending drug approvals in the U.S. and abroad. In what it considers more egregious cases, the agency turns speech violations over to the Justice Department to prosecute. As we reported in BioWorld Today, several companies, rather than...

WASHINGTON – Although the FDA's vision is bigger than its budget, the agency is guardedly optimistic that it can avoid painful cuts next year.

If the FDA doesn't release its overdue guidance on social media soon, biopharma may beat it to the door with industry best practices for communicating directly with patients in interactive neighborhoods like Facebook.

As the biosimilar road trip gets under way, the FDA is mapping out three distinct routes – follow-ons, biosimilars and interchangeable biologics.

WASHINGTON – Yes, Medicare Part D has produced larger than expected savings, but it might save even more if rebates on brand drugs and biologics were statutory, according to the Health and Human Services Office of Inspector General (OIG).

WASHINGTON – Lawmakers on both sides of the biologics exclusivity issue are arguing the debate in a new forum, international trade agreements.