Protembis GmbH received €20 million (US$21.66 million) in financing from the European Investment Bank to develop its cerebral embolic protection system, Protembo. The intra-aortic filter device deflects embolic material away from arteries leading to the brain during left-sided heart procedures including transcatheter aortic valve replacement.
The first patenting to emerge in the name of Copenhagen, Denmark-based 1Health Gut In Balance ApS (dba Gut In Balance) describes development of an apparatus and system that enables hospitals to produce fecal microbiota transplantation capsules on site, and much more efficiently and cheaply.
Triastek Inc., of Nanjing, China, scored a potential $1.2 billion collaboration and platform technology license deal with Biontech SE to manufacture oral RNA therapeutics with 3D printing technology.
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
The $80 million in financing that Huma Therapeutics Ltd. recently raised is a testament to where the company is and what it achieved at a time when the digital health industry is struggling to raise significant financing, Mert Aral, chief medical officer at Huma, told BioWorld.
For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.
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