The FTC and DOJ revised draft merger guidelines could make it more difficult for companies to clear M&A reviews, but the agencies may have trouble winning challenges in court.
The US Federal Trade Commission and Department of Justice plan to lower the threshold for when mergers are presumed to be anticompetitive, which will result in more challenges to transactions and require companies to spend more time rebutting claims that a merger violates antitrust laws.
The agencies issued a draft update of the merger guidelines, which identify principles that the FTC and DOJ may consider when determining whether a merger is anticompetitive under antitrust laws
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.
