As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea. Other big pharmas, including Switzerland’s Novartis AG, Denmark’s Novo Nordisk A/S and China’s Wuxi Biologics (Cayman) Inc., are also making multimillion-dollar investments in the Asia-Pacific region, according to company announcements made in March 2024.
Samsung Life Science Fund, created jointly by Samsung Biologics Co. Ltd., Samsung Biopeis Co. Ltd. and Samsung C&T Corp., said it invested in Waltham, Mass.-based antibody-drug conjugate (ADC) developer Brickbio Inc. on March 18, as its fifth biotech investment.
At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
Weaving in a loose regulatory end from March 2020 when it deemed nearly 100 NDAs as BLAs, the U.S. FDA released a final rule codifying its current approach to the use of drug master files for those products and their potential biosimilar competition.
The U.S. Inflation Reduction Act (IRA) may look like domestic affair, but the drug price controls it is bringing in are set to impact the biopharma sector across the globe.
The U.S. Inflation Reduction Act (IRA) may look like domestic affair, but the drug price controls it is bringing in are set to impact the biopharma sector across the globe.
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data.