A review of life science current events reported by MedCity News this week:
GSK’s Witty pumps up the pharma’s drug pipeline prospects. GlaxoSmithKline (NYSE:GSK) CEO Andrew Witty has been trying to plant seeds of optimism in an investor community that sees little reason for optimism in the global financial markets.
Hospira commits $375M to make troubled N.C. plant FDA compliant. The FDA sent Hospira an April 2010 warning letter that contained quality assurance and compliance concerns for the Rocky Mount plant. Hospira temporarily shut down the plant to deal with those concerns. But problems persisted. A June inspection resulted in a list of observations that outlined where the plant remained out of line with “current good manufacturing practices,” a document called a Form 483. An August inspection yielded another 483.
Closing the Quality-Affordability Gap in Workplace Mental Health
In an interview, Kyan Health Co-Founder and Chief Commercial Officer Konstantin Struck discussed how Kyan gives mid-market and enterprise employers access to premium workforce mental healthcare, at a price point that is affordable.
Cleveland medical mart: MMPI’s minimum performance requirements. And if Chicago-based MMPI doesn’t hit those benchmarks? The county has several “remedies” that it can invoke, including diverting up to $1 million in payments every two years from MMPI to an escrow account that could be tapped to enhance the project’s sales and marketing. The county could first use that option at the end of year three.
Synthes and the responsible corporate officer doctrine. The sentencing of three of the four ex-directors of medical device manufacturer Synthes to terms ranging from five to nine months over the unauthorized use of bone cement in spinal surgery clinical trials in the case United States. v. Norian crisscrosses between regulatory issues and corporate responsibility.
Spine disc replacement firm Flexuspine adds $2.1M to series B round. In April, the company received regulatory approval to begin a clinical feasibility study of its spinal disc replacement system. Flexuspine said at the time that the milestone marked the first approved clinical study for a total spine arthroplasty system in the U.S.