New draft guidance from the FDA outlines standards for developers planning to submit drug and biological product study data based on real-world data sources. According to the guidance, RWD submissions must comply with data standards set forth in the agency's Data Standards Catalog, and "[s]ponsors should also document in their applicable drug submission changes to data to conform to the current FDA-supported data standards, and the potential impacts of these changes," according to the guidance.
The FDA has given approval to Genentech for its Susvimo injection, a drug-eluting eye implant that is used to treat macular degeneration. "We believe that Susvimo can help people with wet AMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care," said Genentech's Head of Global Product Development and Chief Medical Officer Levi Garraway.
Roche's VENTANA PD-L1 (SP263) Assay has been approved by the FDA for use as a companion diagnostic to identify patients with non-small cell lung cancer who may be treated with Tecentriq, or atezolizumab. "With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment," said Roche Diagnostics CEO Thomas Schinecker.
Biological Dynamics has received breakthrough status designation from the FDA for its Exo-PDAC that is used for the early detection of pancreatic ductal adenocarcinoma. "For far too long, patients have needed innovative technologies with the potential to detect cancer at the earliest stages, and we look forward to working closely with the FDA, to do exactly that," said CEO Raj Krishnan.
A smart bandage that can be used to monitor chronic wounds has been developed by researchers from the National University of Singapore. The bandage can send data in 15 minutes to allow for timely, appropriate care.
The FDA has given breakthrough status designation to Sanford Health for its aortic stent graft system that is used for the treatment of thoracoabdominal aortic aneurysms. The device is inserted via a minimally invasive procedure and is opened in the aorta, preventing the aneurysm from bursting by helping blood flow.
Results of a new study conducted to determine which was a safer greeting, an elbow bump or a fist bump, in methicillin-resistant Staphylococcus aureus-colonized patients found that both caused the transmission of MRSA, though significantly more MRSA colonies were transferred from fists. The study published in the journal Infection Control & Hospital Epidemiology reported that among 40 study participants, MRSA was transferred 10 times through fist bumps and six times via elbow bumps.
Pfizer and BioNTech released data from a late-stage trial evaluating their COVID-19 vaccine booster that found the shot was 95.6% effective. The drugmakers will submit data from the 10,000-patient trial to the FDA and additional regulatory agencies to back the license of boosters in the US as well as other nations.
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