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Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The Federal Trade Commission can pursue billions of dollars in repayments from Cephalon over alleged pay-for-delay tactics to stall the marketing of a generic version of Provigil, the brandmaker’s narcolepsy drug. Read More
Otsuka is again urging a federal judge in Maryland to prevent the FDA from granting any ANDA for generic versions of Abilify, after the agency indicated this week it had not yet decided whether the blockbuster antipsychotic drug’s exclusivity bars generic approvals. Read More
Brandmaker AbbVie and generics firm Teva are facing a second lawsuit over accusations they illegally delayed generic competition on the cholesterol medication Niaspan. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
In response to congressional pressure, the HHS inspector general will investigate how recent increases in generic drug prices have impacted the Medicaid rebate program and whether those increases exceeded the inflation rate in 2005 through 2014. Read More