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...
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.
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).
