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New York State’s surcharge on opioid drug manufacturers to help pay for the costs of the opioid drug abuse epidemic is a constitutional tax, the U.S. Court of Appeals for the Second Circuit ruled Sept. 14. Read More
Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced. Read More
A COVID-19 vaccine won’t be widely available nationwide until late in the second quarter or in the third quarter of 2021, Robert Redfield, director of the Centers for Disease Control and Prevention (CDC), said yesterday at a subcommittee hearing of the Senate Appropriations Committee. But President Trump disputes that timeline. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
A top Roche executive slammed President Trump’s expanded “most favored nations” executive order as an unwise and overreaching policy for reducing U.S. drug prices, contending that the president’s own economic advisers found foreign price comparisons would hinder access to new medicines. Read More
In letters sent yesterday, leaders of the House Energy and Commerce committee urged nine companies developing COVID-19 vaccines to uphold their pledge to maintain high ethical standards and to commit to transparency in making all clinical trial data on their vaccines publicly available. Read More
The pharma industry is pledging to take President Trump’s new executive order aimed at lowering drug prices to court even as Trump considers implementing the order ahead of the Nov. 3 presidential election. Read More
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More
Novartis and Roche have been hit with a combined $526 million in fines by France’s competition regulator for using “abusive practices” to boost sales for an expensive age-related macular degeneration (AMD) drug by discouraging a much cheaper alternative. Read More
FDA Commissioner Stephen Hahn made clear on Thursday that he will not intervene in any decisions made by career staff on COVID-19 vaccine approvals, even though he has the authority to overrule them. Read More
The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More