Shares in Gensight Biologics SA dropped by as much as 41% April 7 on news that the Paris-based gene therapy firm failed to complete a second manufacturing campaign within five months, a setback that could delay a commercial launch of its lead product, Lumevoq, by at least a year.
Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population.
Software Machines and Adaptive Implants in Orthopedics (SMAIO) SA raised $10 million on the Paris Euronext Growth market. The offer price was set at $6.66 a share. “Thanks to this IPO, we will now be able to ramp commercial development of our I-Kontrol arthrodesis platform in Europe and secure a foothold in the United States,” Philippe Roussouly, CEO of SMAIO SA, told BioWorld.
A brainwave biomarker licensed by digital therapeutic startup Empower Therapeutics Inc. showed potential to identify patients with high sensitivity to pain. In a new study carried out by researchers at the University of Birmingham, U.K., the biomarker predicted which patients had a pain score of seven out of 10 or higher (severe pain) following lung surgery.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
Cardiorenal is advancing a digital solution for chronic kidney disease (CKD) patients with a new seed investment. The Grenoble, France-based startup’s product Tenor attracted $3.7 million from investors to secure regulatory clearance in the U.S. and Europe.
Still reeling from the impact COVID-19 has had on its research activities and funding, Cancer Research UK is to launch a new organization combining all its drug discovery expertise in a single team, with a single portfolio, later this month.
Four biopharma companies are pooling some of their chemical data and making it public for the first time as part of the pioneering stage of a European effort to reduce the need for animal testing in drug development.
European biotechnology firms engaged in drug discovery and development raised $1.96 billion in equity investment during the first quarter. That tally represents a drop of 67% on the $5.888 billion invested during the same quarter of 2021, when the COVID-19 crisis drove global and European biotechnology investing to unprecedented levels.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
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