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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
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said in its latest annual report. Read More
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Read More
An FDA sampling study found that difficult-to-manufacture drug products sold in the U.S. consistently met quality standards even when they were made abroad. Read More
The FDA has released a question-and-answer guidance to clarify its policies on inspections, pending drug applications and changes in manufacturing facilities for approved drug products during the COVID-19 pandemic. Read More
Tecentriq is currently approved with a different form of paclitaxel, Abraxane (paclitaxel protein-bound), for adults with mTNBC whose tumors express the PD-L1 protein. Read More