Gilead is in-licensing investigational molecules for influenza, rhinovirus and herpes. Novartis will receive an upfront payment and an additional $291 million in milestones.
The criminal investigation examines research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
SIU professor William Halford had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without routine safety oversight from the Food and Drug Administration, according to ongoing reporting by KHN.
"This researcher went rogue," said Fernandez Lynch, the lawyer who specializes in medical ethics. "When one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again."
The government officials contend that researchers did not officially seek permission for the trial, which took place from April to August 2016.
Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Some advancement on the herpes vaccine front: San Diego biotech Vical recently kicked off a Phase 1/2 trial of its Vaxfectin genital herpes vaccine – a therapeutic inoculation that’s melded vaccine and DNA technologies. Here’s how it works: Vical’s approach directs the immune response in two ways: It teaches immune cells to develop weapons against the […]