KBI Biopharma, a prominent contract development and manufacturing organization (CDMO), encountered a critical issue during a GMP (Good Manufacturing Practice) production run. An unexpected pink discoloration appeared in the cell culture media, a crucial component for biologic drug production. The
The clinical research landscape is on the cusp of a transformative shift with the U.S. Food and Drug Administration (FDA) poised to implement a groundbreaking regulation by May 2025. This regulation mandates the use of a single, centralized institutional review board (sIRB) for multisite trials,
The resignation of Mr. Zhou Honghao, an independent non-executive director from Genor Biopharma Holdings Limited, has sparked considerable debate and concern among investors and market watchers. With the effective date of the resignation set for September 18, 2024, there are critical questions to
The biotech sector is brimming with opportunities that extend far beyond the much-talked-about GLP-1 weight-loss drugs, which have garnered significant attention following the 2024 European Association for the Study of Diabetes (EASD) meeting. While GLP-1 treatments, led by giants like Eli Lilly
GC Therapeutics (GCTx), a biotech company founded in 2019, has captured the spotlight with its pioneering approach to cell therapy. With a mission centered on advanced induced pluripotent stem cell (iPSC)-based medicines, GCTx is driven by its innovative TFome platform. Bolstered by a successful
The competitive landscape of pharmaceutical treatments for achondroplasia, a common cause of dwarfism, is experiencing a seismic shift, thanks to the recent clinical trial results from Ascendis Pharma. BioMarin Pharmaceutical, a long-time player in this niche market, finds itself under significant
Jason Raleigh Purchases $15M in Zenas BioPharma Stock, Boosts Confidence In a remarkable display of confidence, Jason Raleigh, a director at Zenas BioPharma, Inc. (NASDAQ: ZBIO), has made a substantial investment in the company by acquiring $15 million worth of stock. This blockbuster move not only
The landscape of cell therapy manufacturing is on the brink of transformation as Cellares, an Integrated Development and Manufacturing Organization (IDMO), partners with Sony Corporation to integrate advanced cell analysis and sorting technologies into an already sophisticated manufacturing
The ongoing legal battle between MMJ BioPharma Cultivation and the Drug Enforcement Administration (DEA) exemplifies the hurdles faced by companies attempting to break into pharmaceutical-grade cannabis research. MMJ BioPharma has encountered significant bureaucratic delays, stalling their efforts
The world of cell therapy manufacturing is on the verge of a significant transformation. The partnership between Cellares, a leader in automated cell therapy manufacturing, and Sony Corporation, a technological giant renowned for its advanced flow cytometry, promises to reshape this burgeoning
