The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.
And another firm has reached a most-favored nation (MFN) pricing deal with the White House. Johnson & Johnson announced Jan. 8 a voluntary agreement with the Trump administration aimed at improving access and lowering prices for medications in the U.S., in exchange for exempting the pharma firm’s products from tariffs.
Beginning Jan. 1, 2026, China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items, the State Council announced. The move aims to boost collaboration between domestic and international sectors, and to leverage resources of both to expand the supply of high-quality goods.
If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty.
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.
After an all-night negotiating session that concluded after 5 am on Dec. 12, political agreement was finally reached on the long-awaited EU pharmaceutical legislation. The aim of the new rules is to improve patient access and increase the competitiveness of the sector, but for the industry, it was too little too late in terms of the incentives, and potentially damaging in the measures to improve access.
Ireland is taking stock of the implications Trump administration tariffs and drug pricing policies hold for its world-leading biomanufacturing sector, which has been largely built on the back of investment by U.S. pharma companies – and is hugely reliant on exports to the U.S.
The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.
The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.
