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EU authorities have increased scrutiny of Chinese API maker Zhejiang Huahai, the valsartan manufacturer linked to the original contamination of APIs used in blood pressure drugs. Read More
Researchers at MIT say they’ve developed a way for drug sponsors and researchers to share information without compromising private patient details or intellectual property. Read More
A Pennsylvania federal court ruled that more than 20 generic drugmakers must face multidistrict litigation accusing them of a price-fixing conspiracy — but not Teligent. Read More
In the latest legal twist over generics of Allergan’s blockbuster dry eye treatment, Restasis, Teva is suing the FDA for changing its policy on eligibility for 180-day marketing exclusivity for generics. Read More
The FDA is advocating a shared set of scientific and technical standards for generic drugs to help drive product competition and lower prices, according to Commissioner Scott Gottlieb. Read More
The complaint alleged that the companies failed to “monitor, report and prevent the diversion of prescription opioids” and caused the state “extraordinary municipal costs.” Read More
Leading drugmakers are pushing back against an FDA proposal to require independent safety committees for expansion cohorts in clinical trials. Read More