Although consensus was not reached on the World Health Organization’s pandemic agreement, the World Health Assembly recognized the progress made by member states to develop a pandemic agreement and to strengthen International Health Regulations (IHR, 2005) during the 77th World Health Assembly meeting held May 27 to June 1 in Geneva.
The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
South Korea’s Genome & Co. Ltd. (KOSDAQ:314130) shares rose nearly 30% June 3 after it disclosed a potential ₩586.38 billion (US$426 million) licensing deal for its novel antibody-drug conjugate candidate with Switzerland’s Debiopharm International SA.
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.
Obesity specialist Sixpeaks Bio AG emerged from stealth with $110 million in funding and an option to be acquired by Astrazeneca plc within the next two years, subject to filing an IND for the lead product.
News comes from the U.K. Intellectual Property Office at the beginning of May 2024, where Ethicon, a Johnson & Johnson MedTech company, applied for five additional years patent protection for its Ethizia hemostatic sealing patch, whose embedded Pox polymer system dehydrates blood and accelerates the coagulation cascade to in occur in seconds, forming a tight yet flexible seal that maintains a barrier to bleeding.
Two companies – Head Diagnostics Ltd. and Octave Bioscience Inc. – identified biomarkers that could provide objective assessments of disease progression and response to treatment for patients with multiple sclerosis.
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
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