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Europlaz develops neonatal device to save babies' lives
Europlaz Technologies Ltd. has developed a new neonatal flow sensor that could help improve neonatal care and save the lives of babies born prematurely. The company created an integrated ‘sidestream’ ...
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Wick-ed good phase III prostate cancer data light up Candel
Candel Therapeutics Inc. followed this spring’s positive phase II data in pancreatic cancer with favorable results from a phase III study testing the same drug – viral immunotherapy CAN-2409 – in ...
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Engineered T cells can serve as organ-specific delivery service
Researchers from the University of California San Francisco (UCSF) have successfully replicated the design of regulatory T cells, achieving local targeted immune suppression and protection from CAR ...
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Dewpoint and Mitsubishi ink $480M ALS research collaboration
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million ...
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Uniqure stock doubles as FDA points to a BLA in Huntington’s
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies ...
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FDA’s AI PCCP final guidance relaxes indication for use restrictions
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial ...
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Positrigo looks to raise $10M for brain PET system
Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With ...
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ASH 2024: Agios’ mitapivat checks off efficacy; liver toxicity a concern
Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops ...
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Boryung invests $10M in Intuitive Machines for outer space R&D
Following its $60 million investment in Axiom Space Inc. last year, Boryung Co. Ltd. made a $10 million private placement in ...
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Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland ...
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NK-510 approved to enter clinic in US and China
Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical ...
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Bioage tumbles as safety issues halt phase II obesity study
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to ...