Laboratorians, in collaboration with providers, can help optimize the laboratory test menu to guide ordering patterns and ensure that patients receive the right tests, writes Charlene Bierl, MD, director of the division of laboratory medicine in the department of pathology and laboratory medicine at the Hospital of the University of Pennsylvania. Laboratorians should regularly check the choices given to providers and understand the organization so they can guide utilization when needed, she adds.
The FDA announced Wednesday that all blood specimen collection tubes will now be included in an expanded medical device shortage list due to supply shortages caused by increased demand during the pandemic, as well as vendor issues. Lab and health care personnel have been advised to minimize blood collection tube use by performing only medically necessary blood draws and to consider sample sharing between lab departments for available specimens.
In a civil lawsuit unveiled this week, Gilead Sciences accuses 22 defendants of being involved in a network of unauthorized distributors and suppliers that allegedly sold more than $250 million worth of counterfeit HIV drugs to pharmacies over the past two years, endangering patients. Gilead says counterfeiters filled authentic, empty or nearly empty medication bottles with fake or altered drugs and resealed the bottles so they would look unopened.
Process intensification can increase output volumes, reduce costs and facilitate scheduling, says Dirk Mueller, manager of media and process development at Sartorius. Identifying suitable concentrates and developing inline dilution help control costs and environmental impact, and creating a miniature model of each step before making the switch enables different clones and process variants to be tested in parallel over a short time frame, Mueller says.
Innovations in chromatography and filtration will support high growth in the downstream biomanufacturing sector over the next 10 years, according to BIS Research, which predicts a compound annual growth rate of 14.85% for the advanced biomanufacturing market from 2021 to 2031. The report predicts strong performance in the North American market and the highest CAGR in the Asia-Pacific region.
The first phase of construction is complete on Vibalogics' live virus and viral-vector production facility in Boxborough, Mass. Cardinal Group USA was among the overall project managers, DPS Engineering supplied consulting and design services, and Germfree Laboratories constructed good manufacturing practice-compliant modular cleanrooms off-site while demolition and construction were underway.
HHS has extended the COVID-19 public health emergency for the eighth time, continuing flexibility and resources granted to health care professionals to care for COVID-19 patients, among other benefits, for another 90 days. Meanwhile, sources said the White House today plans to unveil details of its plan to distribute hundreds of millions of N95 masks for free through community sites and pharmacies, as part of efforts to mitigate the surge in COVID-19 cases.
The Biden administration announced Friday that Americans can start ordering four at-home COVID-19 tests per household on the website, COVIDTests.gov, which will launch Wednesday. The administration teamed up with the US Postal Service to ship the tests, with shipping expected seven to 12 days after the order is made.
An Omicron-specific COVID-19 vaccine made by India-based Gennova Biopharmaceuticals might be ready within two months after a small clinical trial, according to someone familiar with the matter. Gennova recently submitted Phase 2 trial data to regulatory authorities for the original formulation of its COVID-19 vaccine candidate, which is based on messenger RNA technology.
Cellular Biomedicine Group's C-CAR039, a chimeric antigen receptor T-cell therapy that is being developed to treat patients with relapsed or refractory diffuse large B cell lymphoma, was granted fast track and regenerative medicine advanced therapy designations by the FDA. "The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR-T asset for patients in this indication," says Cellular Biomedicine Group chairman and CEO Tony Liu.
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