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As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Read More
The British government announced Monday that it has reached COVID-19 vaccine supply deals with Pfizer/BioNTech and Valneva, locking in tens of millions of doses of their vaccine candidates for the country. Read More
Democrats on the House’s coronavirus crisis subcommittee have launched an investigation into federal contracts for producing drugs, drug ingredients and supplies essential in the pandemic that they claim have been awarded to businesses politically tied to the Trump administration “without competition or transparency.” Read More
Teva Pharmaceuticals will be front and center in the first bellwether trial over an alleged industrywide generic drug price fixing conspiracy, a federal judge for the U.S. District Court for the Eastern District of Pennsylvania has ruled. Read More
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