The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
Takeda Pharmaceutical Co. Ltd. has stress-tested Engitix Ltd.’s extracellular matrix (ECM) drug discovery platform and is coming back for more, expanding the existing collaboration from liver fibrosis to inflammatory bowel disease (IBD).
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
The biopharma industry signed on to a new pledge to increase the availability of innovative drugs across the EU and shave months from the time patients in some EU member states must wait for access to new drugs. Members of the European Federation of Pharmaceutical Industries and Associations committed to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years after receiving central EU market authorization – if local systems allow it.
C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.
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.