Good morning, everyone, and how are you today? We are just fine, thank you, as we brace ourselves for a looming snowstorm. The shovels, the salt, and, yes, the cups of stimulation are already handy. Meanwhile, though, there is much to do as meetings, deadlines, and whatnot await. No doubt, you can relate. So here are a few tidbits to pave the way. Have a smashing day and do keep in touch …
The Food and Drug Administration’s Office of Prescription Drug Promotion sent Pfizer’s (PFE) Hospira subsidiary a letter because the drug maker ran a “misleading” YouTube video for a sedative known as Precedex. According to the letter, there were many claims in the video about effectiveness, but there was no mention of negative side effects, which created “a misleading impression about the drug’s safety.”
Zhejiang Hisoar Pharmaceutical, which is based in China and makes ingredients for some of the world’s biggest brand-name drug makers, was banned by the FDA from shipping its products to the United States, Bloomberg News writes. An agency inspection last August found quality-control records were deleted and test records had been altered, and failing test results sometimes went unreported.
Due to a pending snowstorm, the FDA delayed a widely anticipated advisory panel meeting scheduled for Friday to review a Duchenne muscular dystrophy drug from Sarepta Therapeutics (SRPT). A new date was not announced. Already, though, hopes are dimming that the agency will approve the treatment after the agency last week posted a negative assessment by its staffers. The FDA already rejected a DMD drug from BioMarin Pharmaceuticals.
StemCells, which is developing a potential spinal cord injury treatment, paid its former chief executive Martin McGlynn more than $1 million as he resigned from the company this month, but the company has laid off employees and accumulated a nearly $450 million deficit without getting a drug through the Phase 3 approval process, The San Francisco Business Times observes.
GlaxoSmithKline (GSK) chief executive Andrew Witty says the company’s consumer health business could stand on its own in response to investor pressure to break up the drug maker, Bloomberg News reports.
Four Indian drug makers received the first round of licenses from the Medicines Patent Pool to make generic versions of the daclatasvir hepatitis C treatment made by Bristol-Myers Squibb, The Hindu Business Line says.
GlaxoSmithKline is reportedly holding talks with Qualcomm, the mobile technologies company, about a possible joint venture focused on medical technology, Pharma Times says.