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AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
Boehringer Ingelheim is aiming to broaden its research into diabetes and other cardiometabolic diseases via a partnership with Circuit Therapeutics to develop novel drugs to treat obesity. Read More
A Luxembourg-based nonprofit set up by European pharma groups is one step closer to launching a counterfeit drug repository system, having finalized contracts with three software firms to help implement the system. Read More
A recent survey showing that drug company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
Eli Lilly Thursday scored its second court victory in less than a week and third overall in lawsuits against its blockbuster antidepressant Cymbalta. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More