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Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More
Two high-profile drugmakers have entered settlement agreements with federal and state justice departments over kickback allegations for prescribing practices. Read More
The U.S. Treasury Department says it is taking steps to curb tax-avoiding inversion deals, but there is little evidence to suggest it will halt the tie-up between New York-based Pfizer and Allergan that will see the former move its headquarters to Dublin. Read More
Drugmakers engaging in anticompetitive practices don’t get a free pass simply because federal regulators failed to act, the Federal Trade Commission has asserted in a pending court case. Read More
Spotty, inconclusive data and potentially skewed, biased findings have raised FDA concerns about the efficacy of BioMarin Pharmaceutical’s Duchenne muscular dystrophy candidate drisapersen, which is scheduled to go before members of an agency advisory panel tomorrow. Read More
The FDA has given Takeda’s Ninlaro the green light of approval in combination with other therapies to treat multiple myeloma in the second-line setting. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More