Mallinckrodt has filed for Chapter 11 bankruptcy protection after announcing a proposed $1.6 billion settlement to resolve opioid-related lawsuits. The drugmaker said it plans to settle claims stemming from the opioid crisis and lower its debt during the bankruptcy process.
Johnson & Johnson said it has temporarily halted clinical trials of its COVID-19 vaccine candidate to allow investigation of an unexplained illness in one participant. The company said the patient's condition is being evaluated by its clinical and safety physicians and an independent data and safety monitoring board.
The US government has signed a supply deal with AstraZeneca worth $486 million for 100,000 doses of the company's investigational COVID-19 antibody treatment should it gain FDA approval, and the agreement also funds two late-stage trials. HHS will provide funding through Operation Warp Speed, with distribution to begin later this year, and a separate deal includes an option to purchase an additional 1 million doses in 2021.
Using Technology in the Fight Against COVID-19 Health care providers around the world are facing unprecedented challenges but also opportunities to rethink healthcare. What new health IT models have emerged amidst the pandemic? What will the new normal look like? Listen to this panel discussion with healthcare experts around the world to find out. Watch on-demand.
The FDA has given emergency use authorization to Access Bio for its CareStart COVID-19 Antigen test, to Genalyte for its Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 and to Spectrum Solutions for its SDNA-1000 Saliva Collection Device.
The FDA has proposed rules to standardize tracing records for foods with a "high risk" for contamination including ready-to-eat salads, shelled eggs, tomatoes, cucumbers and crustaceans. Of particular interest are records of critical tracking events.
The European Medicines Agency on Oct. 19 will launch an online platform, IRIS, for drug developers to use when seeking scientific advice, protocol assistance and qualification procedures. Users must have an EMA account and register before submitting requests, documentation and other information through IRIS.
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