Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Hyperfine, Zeta Surgical.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
While uncertainty often casts a shadow on the Street, U.S. investors welcomed the presidential and congressional election results with a late-night surge that carried into the morning Nov. 6. The Dow Jones peaked at 1,380.47 points early the day after, up 3.27% from Election Day itself and hitting its highest point of the year so far. The celebration extended to the biotech sector, with the BioWorld Index, which covers more than 500 companies, up 17.06% for the year, compared with a 12.28% increase for the year on Nov. 1.
The EU’s still-new regulations for medical devices and in vitro diagnostics are often seen as drivers of current or impending shortages of these products, but Oliver Eikenberg of regulatory consultancy Pure Global is unimpressed by such claims. Eikenberg said much of the drag on the EU system is engendered by device makers that are failing to get their regulatory affairs in order – a problem neither Brussels nor the notified bodies can fix.
Prognomiq Inc. secured $34 million in a series D funding round to advance development of an early detection test for lung cancer based on its multiomics platform. The blood-based test could provide an alternative to the underutilized low-dose CT scans currently recommended for individuals at high-risk of lung cancer.
Data from two Alzheimer’s tests being developed by Roche Holding AG showed high accuracy in detecting the disease in patients being tested for the condition. The tests measure biomarkers in the blood linked to Alzheimer’s and will help provide desperately needed information by letting patients know whether they have the disease or not, Margherita Carboni, Neurology Indication Lead at Roche Diagnostics told BioWorld.
The FDA announced a class I recall of Evair compressors by Chicago-based GE Healthcare due to elevated levels of formaldehyde when the devices are used with specific models of Carescape or Engstron ventilators.
RSS
