Counterfeits or substandard generics? Clash over definitions roils global anti-counterfeiting initiative. WHO IMPACT members divide over conflicting goals: protecting brands from counterfeits; protecting generics from being branded as counterfeits; and protecting emerging markets from substandard generics. Blowup over Dutch customs seizures. IMPACT begins to regroup as anti-counterfeiting regulatory landscape grows increasingly complex. U.S. pursues slow-tracked trace-and-trace; California e-pedigree stymied. The E.U. advances with pharmacy verification approach, registers a success with EFPIA pilot. Council of Europe works to criminalize counterfeit drugs. USP and AID minilabs would empower developing regulators. One third of antimalarials were substandard. Nigeria enables consumers to check for counterfeits by cell phone. Baxter takes layered approach. A pressing need for on-dose protection seen, but it must be covert. The day of mass serialization will arrive, but there will be no panacea.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.
