Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA.
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.
Beijing Innocare Pharma Tech Co. Ltd. has received IND approval from China’s National Medical Products Administration (NMPA) for ICP-B208, an antibody-drug conjugate targeting CDH17, which is highly expressed in gastrointestinal cancers, including colorectal, gastric and biliary tract cancers and pancreatic ductal adenocarcinoma.
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
Simcere Zaiming Pharmaceutical Co. Ltd.’s SIM-0613 for injection has received clinical trial approval from China’s National Medical Products Administration (NMPA), enabling initiation of a clinical trial for advanced solid tumors.
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
China’s investigator-initiated trial (IIT) system is increasingly being used to generate early human data in cell and gene therapies, and new changes that widen the pathway are expected to drive more multinational companies to conduct IITs in China, panelists said during the Chinabio Partnering Forum in Shanghai April 28-29.
For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report.
Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years.
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
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