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The House Energy and Commerce Committee approved five measures that would address orphan drugs, generic drugs, drug safety and drug manufacturing during a virtual markup yesterday, sending them to the full House. Read More
In a win for AbbVie, a preliminary ruling from a U.S. International Trade Commission (USITC) judge could lead to a 10-year ban on a competitor’s Botox treatment. Read More
The House Appropriations Committee has signed off on a fiscal 2021 measure that would give the FDA $3.2 billion in funding, an increase of $40.8 million from fiscal 2020, and give the agency power to require recalls. The legislation is now headed to the full House for consideration, although no date has been set. Read More
The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Read More
Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The SEC also charged the company’s subsidiaries in Brazil and Colombia for inaccurate financial records of payments to patient advocacy organizations. Read More
A federal appeals court has ruled that two Amgen patents for its blockbuster anti-inflammatory drug Enbrel are valid, blocking the launch of a biosimilar by Novartis. Read More
PhRMA has filed a lawsuit challenging a new Minnesota law that took effect on Wednesday that provides emergency access to long-term insulin for diabetics who cannot afford it. Read More