WASHINGTON – It took Congress nearly a decade to pass the first major patent reform bill in nearly 60 years. Now it could take another decade or so for the new act to be thoroughly fleshed out in the courts and the Patent and Trademark Office (PTO).
WASHINGTON – Patent reform became a reality Thursday evening when the Senate voted 89 to 9 to send the House version of the America Invents Act to the president for his signature.
When the planes crashed into the World Trade Center 10 years ago, the U.S. woke to a "new normal" – a frightening awareness of the nation's vulnerability.
WASHINGTON – The likelihood that the National Center for Advancing Translational Sciences (NCATS) will open Oct. 1 as originally proposed is looking dim since the National Institutes of Health (NIH) still needs the go-ahead from Congress before it can launch the new center.
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...
