The Cook County Circuit Court revived a 2013 lawsuit against DePuy Orthopaedics and Premier Orthopaedics Sales alleging negligence in designing a hip replacement device. Source: The GMP Letter
In the first ever recall for a cybersecurity risk, Abbott recalled 465,000 implantable pacemakers for a firmware update to reduce the risk of unauthorized access. The update requires an in-person…
A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths…
The FDA rolled out its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ…
A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Source: Generic Line
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Source: Generic Line
Life Sciences Jobs ... Source: BioSpace
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-shire.jpg" NAME"It's Official: Shire Takes Over Ariad's Old Space in Kendall Square" ALT"It's Official: Shire Takes Over Ariad's Old Space in Kendall Square"October 9, 2017By Alex Keown, BioSpace.com Breaking…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks4.jpg" NAME"Proteostasis and Roche Diagnostics Ink Huge Space in New Boston Hub" ALT"Proteostasis and Roche Diagnostics Ink Huge Space in New Boston Hub"October 9, 2017By Alex Keown, BioSpace.com Breaking…