Thermo Fisher Scientific has partnered with First Genetics JCS to commercialize next-generation sequencing-based diagnostics in Russia. First Genetics will market its F-Genetics NGS System and IVD assays to Russian laboratories for cancer diagnostics and reproductive health testing.
Siemens Healthineers has signed a 10-year comprehensive service logistics agreement with DHL Supply Chain. Under the agreement, the companies will build a distribution center in Memphis, Tenn., that will be operated by DHL.
Edwards Lifesciences has agreed to settle patent disputes with Abbott concerning tricuspid repair and transcatheter mitral products and has given the latter an undisclosed one-time payment.
A Series A financing round has raised $8 million for Israel-based NovaSight. The funds will be used to support a multi-center randomized pivotal study of the company's CureSight, a device used to treat lazy eye, and for future eye care product developments.
Researchers from Arizona State University's Biodesign Institute are working on a saliva-based COVID-19 test that can deliver results within one to two days, is less invasive and requires only a small amount of saliva.
GlaxoSmithKline began its "NuNormal" advertising campaign for its eosinophilic asthma treatment Nucala online in 2018 and has expanded it to national television ads. Only 25% of patients with the disease are treated, despite the awareness campaign and other treatments on the market.
Twenty draft and final guidelines were withdrawn by the FDA's Center for Biologics Evaluation and Research last week. More than half were issued in the 1980s and 1990s, and the majority were related to donor screening, HIV, donor and blood products.
The FDA is proposing to revise some of its recommendations related to software, nonclinical performance testing and pyrogenicity testing in the final guidance for 510(k) submissions of peripheral vascular atherectomy devices. The agency also proposes to make several changes in its 2010 guidance on clinical and nonclinical investigations for devices meant to treat benign prostatic hyperplasia, including those related to animal, pilot and pivotal studies.
The FDA has released the New Era of Smarter Food Safety blueprint, which outlines the agency's plan to protect the US food supply chain and establish a more digital, traceable supply chain through the use of modern technologies. "The blueprint we release today represents ... a commitment we are making to the American people that we will work as fast and effectively as we can to help ensure that we have the safest food system in the world," FDA Commissioner Stephen Hahn said.
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