Alex Gorsky will replace William Weldon as Johnson & Johnson CEO in April. Like his predecessor, who has led during a time of extensive OTC recalls, Gorsky’s experience with J&J comprises management of Rx pharmaceutical and medical device businesses, with no consumer background.
Johnson & Johnson’s selection of Alex Gorsky as its seventh chief executive suggests the pharma company will not make its consumer business a higher priority.
Gorsky will succeed CEO William Weldon in April. Like Weldon, the 51-year-old Gorsky’s experience comprises management of Rx pharmaceutical and...
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
