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The chief administrative law judge of the PTO’s Patent Trial and Appeal Board issued guidance to holders on how to amend their patents after being challenged with an inter partes review. Read More
A Philadelphia jury found Bayer and Johnson & Johnson liable for the injuries of a woman prescribed their prescription blood thinner Xarelto, following three consecutive victories for the drugmakers in similar “bellwether” cases. Read More
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Genentech and Pfizer urged the FDA in written comments to make its draft guidance on statistical analyses of analytical similarity data for biosimilars more specific and narrower in scope.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