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The agency is considering assessing the orphan designation at the marketing authorization stage to encourage applications for rare disease treatments. Read More
CMS approved Michigan’s plan to allow its Medicaid program to negotiate “value-based” payment arrangements with drugmakers, linking drug costs to patient outcomes such as quality of life improvements, CMS Administrator Seema Verma announced Wednesday. Read More
The agency said the EU will monitor developments in the field to ensure that the regulatory framework supports —and not hinders — the development of ATMPs. Read More
Despite the opportunity to bring the excepted generic application drugs to market, the company’s “obstinate delay tactics and excessive compliance failures continued,” according to the complaint. Read More
Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of its blockbuster pain treatment. Read More
New Jersey’s attorney general claims Janssen falsely marketed its opioids Nucynta (tapentadol) and Nucynta ER as less addictive than other opioids in the state’s first such lawsuit against a Garden State-based drugmaker. Read More