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AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More
UCB’s Cimzia may soon be added to the list of arthritis drugs provided under England and Wales’ National Health Service, following a final draft recommendation by the UK’s healthcare cost watchdog. Read More
HHS’ Office of Inspector General has added four new projects to its 2015 work plan, including the creation of a Medicare Part D oversight portfolio and a review of states’ reporting on Medicaid rebate collections. Read More
A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for drugmakers to sue for patent infringement, a patent law attorney said. Read More
Drugmakers seeking marketing authorization in the EU may request a meeting with the European Medicines Agency to discuss questions posed by the agency’s advisory committees, updated guidance says.
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A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More