In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
The U.K. government is to invest £500 million (US$645 million) in a health data research service that will provide a single point of access to national-scale anonymized patient records, ending the need to navigate different systems or make multiple applications to use information.
The sparsity of mid-to-late stage prospects in atopic dermatitis (AD, or eczema) – which has proved an especially challenging indication – plus some newsmaking fizzles in the space have caused developers to probe new targets with particular intensity. Most popular approaches thus far involve IL-4, IL-13, thymic stromal lymphopoietin and JAK. Developers have stumbled for varying reasons such as high placebo response rates, safety or lack of clinical proof of concept. Among the potential AD rescuers is Nektar Therapeutics Inc. with rezpegaldesleukin (rezpeg), which takes aim at IL-2.
“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February.
When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new company called Merida Biosciences focused on removing misdirected antibodies and their negative effects using Fc biotherapeutics.
Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning Boston Sci to challenge Johnson & Johnson’s Shockwave IVL system, which has been the only player in the market.
The U.S. FDA has cleared regenerative medicine company Orthocell Ltd.’s 510(k) for its nerve repair product, Remplir, paving the way to begin commercial operations in the $1.6 billion U.S. nerve repair market.
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