Gritstone Bio Inc. has had a tough year and new interim phase II data of Granite haven’t helped. The company called the progression-free survival results “encouraging” in the ongoing phase II/III trial of its personalized neoantigen-targeting immunotherapy for treating front-line microsatellite stable colorectal cancer.
Shattuck Labs Inc. opted, as one analyst put the matter, to do “the right thing early” by ending the clinical program with phase I-stage SL-172154 and shift resources to SL-325, a death receptor 3 antagonist, initially for inflammatory bowel disease, where TL1A/DR3-blocking antibodies have shown compelling monotherapy efficacy.
Depending on how long it lasts, the dockworkers strike that hit all 14 ports on the U.S. East Coast and along the Gulf Oct. 1 could literally unload a world of hurt to patients and the biopharma/med-tech industries, as it will impact both U.S. imports and exports of life-saving drugs and technologies.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
A study presented at the American Society for Radiation Oncology on Oct. 1 offers promise for the treatment of high-grade gliomas using Elekta AB’s Unity MR-Linac system.
The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.
Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement its proposed 340B rebate model pending resolution of the issues.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
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