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In a move applauded by domestic drug groups, the U.S. Trade Representative added Canada to its priority watch list of countries with lax intellectual property protections or market access barriers for drugs. Read More
Citing concerns among stakeholders including the FDA, the U.S. Pharmacopeia decided not to move forward with proposed revisions to its nomenclature for biologics. Read More
Citing a Merck in-house attorney’s dishonesty under oath, the Federal Circuit upheld a 2016 ruling that dismissed a $200 million verdict against Gilead, affirming that Merck unethically obtained the rights to two patents. Read More
The International Brotherhood of Teamsters — shareholders in McKesson — expressed skepticism about the outcome of a probe that cleared the drug company’s leadership of contributing to the opioid epidemic. Read More
In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines. Read More
Sponsors conducting clinical trials using imaging-based primary endpoints should consider the choice of modality — such as echocardiography or single-photon emission computed tomography — as well as centralized image interpretation and how often image evaluations should be performed, according to final guidance from the FDA. Read More