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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
A coalition of healthcare and patient advocacy groups Tuesday urged congressional leaders not to reduce the manufacturer discount for Medicare Part D drugs. Read More
The FDA Tuesday issued draft guidance for clinical trial sponsors of treatments for a rare form of prostate cancer — nonmestastatic, castration-resistant prostate cancer (nmCRPC) — and said it will consider metastasis-free survival as an endpoint. Read More
Researchers in low-risk clinical trials could experiment on patients without obtaining informed consent if they meet at least four conditions, the FDA proposed Tuesday in a new rulemaking notice. Read More