If U.S. sectoral tariffs on biopharmaceuticals become a reality and most country-by-country tariffs on other medical products resume, manufacturers may have to rethink their use of U.S. free trade zones to turn foreign-sourced active pharmaceutical ingredients and other components into finished products for the U.S. market.
Researchers have developed a new compound that can prevent long COVID symptoms in mice that could lead to a future drug for the debilitating condition in humans. Developed by researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, the world-first study found mice treated with the antiviral compound were protected from long-term brain and lung dysfunction, which are key symptoms of long COVID.
The EU’s Medical Devices Coordination Group (MDCG) issued another revision of its guidance for risk classification for in vitro diagnostics — the fourth such rewrite of a guidance that came out in 2020.
Compared to other forms of prevention, a unique issue for pandemic preparedness is that it is forever unclear what pathogen, exactly, the world needs to be prepared for. There are an estimated 300,000 viruses that infect mammals; add in birds, and the estimate grows to more than half a million. Some of those viruses are much greater threats than others.
Brainomix Ltd. raised £14 million ($18 million) in a series C financing round to expand its AI-powered imaging solution, Brainomix 360 Stroke, into the U.S. market. Funds will also go towards advancing the Brainomix 360 E-Lung, which can accurately predict the progression of lung fibrosis. “This series C round is a vital fundraise for us,” Michalis Papadakis, CEO and co-founder of Brainomix, told BioWorld. “We are in a growth stage where we want to bring this next generation of stroke AI into the U.S. market.”
In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs.
Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
To increase diagnosis across Australia, the partnership will see Compumedics Ltd. of Melbourne supply its Somfit devices and electrodes to Philips’ pharmacy-based sleep programs in pharmacies across Australia.
The lung and thrombosis may play a key role in cancer and metastasis progression, according to a collaborative study led by Cornell University scientists. In the nonmetastatic lung microenvironment of several cancer types, the development of a prothrombosis niche promotes metastasis formation through the release of small extracellular vesicles loaded with an integrin protein.