Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (ModMed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into ModMed's gGastro EHR software to enhance endoscopic care.
The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Intriguing data in pancreatic cancer didn’t do much to help shares of South San Francisco-based Cytomx Therapeutics Inc. (NASDAQ:CTMX), which closed May 9 at $2.04, down $2.15, or 51%, as the company made known initial findings from the ongoing CX-904 phase Ia dose-escalation study, showing a favorable safety profile and confirmed anticancer activity.
Three years ago when Keting Chu pondered the name for a new biopharma company that would fold in infectious disease assets from Novartis AG, she looked out over her West Coast backyard. “I was looking for a name that made you think of California,” she told BioWorld. She nixed the idea of incorporating redwood trees into the name, but then she saw the blue jays flying around those trees and thought, “that’s a beautiful bird.” Hence, Chu founded and became CEO of Bluejay Therapeutics Inc., first raising $20 million through a series A in June 2021 and a $41 million series B in August 2022. On May 9, the San Mateo, Calif.-based company closed a $182 million series C round, with plans to accelerate development of lead compound BJT-778 to treat chronic hepatitis D virus, a condition for which there are no approved therapeutics in the U.S.
In a research collaboration that could bring in up to $600 million, Metaphore Biotechnologies Inc. has become the third Flagship Pioneering company this year to cut a development deal with mighty obesity space player Novo Nordisk A/S.
As the average cost of new drug R&D continues to skyrocket, the perception around using artificial intelligence (AI) as a tool to boost drug discovery is changing. “Developing new AI-based drugs is a difficult task, not only for Korea but also for countries with leading AI technology,” Hyeyun Jung, principal researcher of Korea Health Industry Development Institute’s Center for Health Industry Policy, told the audience at the Bio Korea meeting on May 9. “But there is a change in perception; [namely that] applying AI to new drug development is not an option but a necessity.”
In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.
The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction between servicing and remanufacturing of a device. However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on these entities.
Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.
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