US government alleged sales reps gave information to physicians to create a false or misleading impression that Victoza's boxed warning and REMS messages about medullary thyroid cancer were 'erroneous, irrelevant or unimportant.' Novo's $59m settlement includes resolution of whistleblower lawsuits alleging off-label marketing.
Novo Nordisk AS' settlement of allegations that it downplayed and circumvented risk communication messages required under the Risk Evaluation and Mitigation Strategy for the diabetes drug Victoza (liraglutide) suggests another legal avenue for US government prosecution of behavior it views as related to off-label promotion.
On Sept. 5, the US Department of Justice (DoJ) and Novo Nordisk announced they had reached a $58.65m settlement on...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says.
The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.
The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
