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Drugmakers have improved at clinical trial transparency compared to 2015, with Sanofi and Johnson & Johnson sharing first place in a transparency ranking sponsored by Bioethics International. Read More
Testifying before a UK House of Commons committee Tuesday, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. Read More
Genentech and Pfizer urged the FDA in written comments to make its draft guidance on statistical analyses of analytical similarity data for biosimilars more specific and narrower in scope. Read More
The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More
Dr. Reddy’s Laboratories said it will contest a class-action lawsuit by investors who claim the company made false or misleading statements about its quality system. Read More