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9/24/2021

A study in the journal Nature Communications found that antibodies generated from COVID-19 vaccines may not bind well to the spike proteins of new coronavirus variants. The study team hopes to look next at how well vaccine-produced antibodies bind to other parts of the new variants.

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HealthDay News
9/24/2021

Slow parasite clearance was found in 5.8% of malaria patients in Uganda being treated with a derivative of artemisinin between 2017 and 2019, which can be a sign of emerging resistance to the treatment, and a genetic analysis found malaria mutations associated with artemisinin resistance, according to a study in the New England Journal of Medicine. "The association that we found between clinical artemisinin resistance and the presence of the A675V and C469Y mutations raises the possibility that these resistance markers can be used to assist in the detection of artemisinin resistance among patients with P. falciparum infection in Africa," the study team wrote.

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P. falciparum
9/24/2021

Diagnostics companies like Beckman Coulter, Roche and Siemens Healthineers saw a strong year amid the COVID-19 pandemic and anticipate ongoing high demand next year. Investments in diagnostics during the pandemic are expected to "bring forward the next generation of testing to market," said Deepak Nath, president of laboratory diagnostics at Siemens Healthineers.

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Siemens Healthineers, Roche
9/23/2021

The rolling biologics license application from bluebird bio for betibeglogene autotemcel, a single-dose gene therapy for transfusion-dependent beta-thalassemia has been received by the FDA. The BLA seeks the agency's approval for children and adults with beta-thalassemia who receive frequent transfusions of red blood cells.

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Thalassemia
9/23/2021

The US average for new COVID-19 cases has declined to about 135,000 over the past week, down 18% from the start of September, and hospitalizations have also decreased to 91,500, according to data from Johns Hopkins University. The weekly average for reported COVID-19 deaths, however, climbed 13% from the prior week to 2,031, the highest daily average since March.

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CNBC
9/23/2021

Incyte's Jakafi, or ruxolitinib, gained the FDA's approval as a treatment for chronic graft-versus-host disease in patients 12 and older who have previously received one to two systemic therapies. Ruxolitinib was previously approved as a treatment for acute GVHD.

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Ruxolitinib
9/23/2021

A wide swath of small and medium-size biopharmaceutical companies is embracing hybrid work structures to the extent the nature of the work allows, and they've introduced additional safety protocols and mental health and well-being resources and policies. Virtual and hybrid workplaces have enabled companies to expand job candidate criteria and may have had a positive impact on diversity and inclusion, company leaders say.

9/23/2021

Progress in cell and gene therapy development is impeded by preclinical models with poor predictive value, too few clinical trial participants for robust results, backlogs for expensive reagents and manufacturing equipment, regulatory uncertainty, price pressures and a lack of health care settings with highly skilled staff and specialist infrastructure, write PA Consulting life sciences experts Paul Stroemer and Paolo Siciliano. Solutions include forming partnerships, adopting novel clinical trial designs such as basket trials, and standardizing and automating production processes.

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Bioprocess Online
9/23/2021

Seattle-based AGC Biologics is adding a good manufacturing practice-compliant manufacturing line and a GMP cleanroom for messenger RNA production at its Heidelberg, Germany, facility. The upgrades will also add capacity for small-scale production of plasmid DNA, a spokesperson said.

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BioPharmaReporter
9/23/2021

The onshoring trend and capacity constraints at contract manufacturing facilities have some drug developers exploring the possibility of moving manufacturing in-house, which can bring benefits including greater control over production and quality, writes Joan Benson, regulatory governance and assurance manager at Connect 2 Cleanrooms. "ISO and MHRA-compliant manufacturing environments that are suitable for activities regulated under GMP can be installed into existing buildings, or even into modular cabins if space is at a premium," Benson writes.

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