- Whistleblowers accuse Merck of withholding info on mumps vaccine (fiercevaccines.com)
If Merck has answers regarding the efficacy of its mumps vaccine, it's not being forthright, says a letter filed by an attorney representing two former Merck virologists who are now whistleblowers. Originally filed in 2010, the suit claims that the pharma giant skewed the tests of its U.S.-exclusive mumps vaccine by adding animal antibodies to blood samples, resulting in 95% efficacy that kept competitors--who couldn't match the efficacy--off the market.
- U.S. jury clears Pfizer in second trial alleging Zoloft birth defects (reuters.com)
A U.S. jury on Thursday said Pfizer Inc. was not responsible for birth defects in a young girl whose mother took its antidepressant Zoloft while pregnant, the second straight win for the company out of hundreds of similar lawsuits. Plaintiff Rachel Robinson claimed in her 2011 lawsuit that Pfizer failed to warn that using Zoloft during pregnancy could cause birth defects and sought damages from the company after her now eight-year-old daughter was born with a rare, serious heart problem.
- You’re free to speak, FDA tells Amarin in bid to deflate free-speech suit (fiercepharma.com)
Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.
- Roche sclerosis drug granted Breakthrough Therapy status (mmm-online.com)
The FDA granted Breakthrough Therapy status to Roche's Actemra for systemic sclerosis, a connective tissue disease that is characterized by the hardening of the skin. The Breakthrough Therapy designation speeds drugs through the FDA review process and is applied to drugs that appear to offer a significant benefit over treatments that are currently on the market or that treat serious diseases for which no treatment is available.