New guidance from the American Society of Hematology on hematopoietic stem cell transplants for patients with sickle cell disease was published in the journal Blood Advances. The recommendations include performing transplants earlier in life for patients where transplant is indicated and a matched donor is available.
A study published in the CDC's Morbidity and Mortality Weekly Report found individuals who have received COVID-19 vaccines from Pfizer/BioNTech, Moderna or Johnson & Johnson had lower risk of dying from any cause in the months following vaccination, compared with unvaccinated individuals. The study, based on data from 11 million people, "reinforces the safety profile of currently approved COVID-19 vaccines in the United States," researchers said.
Technology for continuous manufacturing has been available for at least six years, but the risk-averse biopharmaceutical industry is hesitant to adopt new technologies, says consultant John Wahlich, an affiliate of the Academy of Pharmaceutical Sciences. However, adoption is accelerating as technology improves and regulatory standards are set, and the need for flexibility to personalize medicines, along with on-shoring, may tip the balance, Wahlich says.
Public health experts, including former CDC Director Tom Frieden, say producing COVID-19 vaccines in hard-hit, low-resource regions is vital to curb the pandemic and prevent more SARS-CoV-2 variants from emerging. Frieden says producing vaccines in low-income countries is technically feasible, and while the leaders of Pfizer and Moderna say messenger RNA vaccines are too complex to license, drugmakers in Africa, South America and Asia say they already have much of the equipment and expertise they need, and some have already started manufacturing.
The University of Delaware and Waters Corp. are partnering on Immerse Delaware, an innovation and research lab where company researchers, university students and faculty will collaborate to advance biopharmaceutical manufacturing. The first projects under the five-year pact will quantify and minimize process-related impurities related to uncontrolled glycosylation.
The state of Illinois awarded a $2 million matching grant to complete the area for industry tenants at Rosalind Franklin University's Innovation and Research Park, a life sciences incubator and accelerator with 100,000 square feet of wet lab space.
CHA Biotech subsidiary Matica Biotechnology and Sartorius signed an agreement to develop viral vector process analytical technology and automation software using Sartorius' single-use platform.
The makers of parenteral drugs, vaccines and medical devices have long used the blood of horseshoe crabs to test for endotoxins, but as many as an estimated 30% of the ancient sea creatures die after being captured, bled and returned, and conservationists are calling for the practice to end. Synthetic alternatives are available from companies including Lonza, and Eli Lilly switched to a synthetic alternative in 2016, but while other drugmakers have started converting their testing, uptake is slow in the risk-averse industry.
The CDC Clinical Standardization Program for Cardiovascular Disease Biomarkers is evolving, including lowering treatment targets for LDL-cholesterol and changing its protocols to better assess analytical performance at lower lipids levels, writes Uliana Danilenko, lead research chemist in the clinical chemistry branch at the CDC in Atlanta. "Measurements of traditional blood lipids do not fully capture CVD risk in all patients, and lipoproteins can provide more detailed information about a person's risk for CVD," Danilenko notes, adding that the program will address this by including Lp(a), ApoB, and ApoA1.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said children in the US ages 5 to 11 may be able to get COVID-19 vaccines early next month, after Pfizer/BioNTech reported that the shot is 90.7% effective against symptomatic COVID-19 in young children and the FDA said the vaccine's benefits outweighed the risks. An independent FDA advisory panel will meet Tuesday to consider the data, and Pfizer board member Dr. Scott Gottlieb said the company is ready to ship pediatric doses immediately if authorized.
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