The U.K. is mulling over whether to recognize U.S. FDA approvals of medical devices as part of moves to accelerate the implementation of its post-Brexit regulatory system.
Minervax Aps has closed a €72 million (US$76.6 million) financing round, enabling it to accelerate phase II development of its group B streptococcus (GBS) vaccine for the prevention of stillbirth and serious infections in newborns and complete the program next year.
Scientists in Edinburgh are planning a clinical trial of licensed drugs in the prevention of chronic kidney disease (CKD) following acute kidney injury (AKI), after uncovering a new mechanism linking the pathology of one with the other. It has only recently been recognized that AKI is linked to CKD and cardiovascular disease, and to date the molecular pathways that control the transition are not well-mapped. As a result, there are no therapies for preventing acute injury progressing to chronic disease.
The U.K. is taking the next step in applying genomics to health care with the launch of a £105 million (US$130 million) project that will sequence the whole genomes of 100,000 healthy newborn babies to detect rare genetic conditions.
The European Commission has given in to the increasing pressure and alarm from member states and is moving to extend the deadlines for implementing the 2017 Medical Device Regulation (MDR) and the In Vitro Devices Regulation (IVDR).
Olive Diagnostics Pvt. Ltd. is looking to raise $10 million in a series A funding round to extend sales and marketing activities, after getting CE approval for its urine analysis device that mounts on any toilet. Among other parameters the device, Olive KG, can measure red blood cells, proteins, nitrates, pH levels volume, pressure and frequency of urination.
Doctors at Great Ormond Street Hospital London have reported the first successful use of base-edited donor T cells, in the treatment of refractory T-cell lymphoblastic lymphoma. The case of a 13-year-old girl named Alyssa, whose disease had not responded to chemotherapy and a bone marrow transplant, was presented at the American Society of Hematology meeting in New Orleans on Dec. 11, 2022.
New research has identified a novel receptor that interacts with the angiotensin-converting enzyme 2 (ACE2) by which the SARS-CoV-2 enters host cells, and shown it can be inhibited with marketed drugs, reducing expression of ACE2 and blocking viral entry.
Accession Therapeutics Ltd. has raised £16.6 million (US$20.3 million) in a series A round, as it prepares to take two targeted oncolytic/payload combination viruses into the clinic. At the same time, the company disclosed that the scientist who devised the tumor-only targeting mechanism is Alan Parker, professor of translational virotherapies at Cardiff University.
Switzerland is making moves to allow the import of U.S. FDA-approved medical devices after losing barrier-free access to the EU market and over rising concerns about the dismal pace of implementation of the EU’s upgraded devices regulations.
