The guardian | May 03, 2020
Swiss drug maker Roche Holding AG says it has received emergency use approval from the US Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus. Governments, businesses and individuals are seeking such blood tests to help them learn more about who may have had the disease, who may have some immunity and to potentially craft strategies to end lockdowns that have battered global economies. Roche had previously pledged to make its antibody test available by early May and to boost production by June to “high double-digit millions” per month.
fiercepharma | August 12, 2020
Some of the world’s largest biopharma companies are working to deliver safe and effective COVID-19 vaccines, but at the same time, a much smaller biotech has laid out its own big ambitions in the field. Novavax will have billions of doses of COVID-19 vaccine capacity next year and could single-handedly meet U.S. demand, executives say. On a conference call Monday, chief medical officer Filip Dubovsky said the Gaithersburg, MD-based biotech expects to be able to make "well over a couple billion units" each year, starting in 2021. That would easily outpace U.S. demand, which Dubovsky estimated will come in at 500 million to 600 million doses annually.
Sebela Pharmaceuticals | January 06, 2021
Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States.
SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. The tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients' willingness to undergo colonoscopy screening for colorectal cancer. 1
The American Cancer Society and the U.S. Preventive Services Task Force recommend adults undergo screening for colorectal cancer beginning at age 45.2 Colonoscopy is the gold standard detection method for colorectal cancer, a leading cause of cancer-related deaths that can be more effectively treated if caught early through screening.3 Within the last decade, the rate of colonoscopy procedures has increased significantly with approximately 18 million people now screened annually for colorectal cancer.
"Alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "With the introduction of SUTAB tablets, we hope to take yet another important step toward removing some of the burden often associated with the preparation process – allowing more patients to feel confident in their choice to undergo a colonoscopy."
The FDA approved SUTAB on November 10, 2020. The approval was based on positive Phase 3 clinical trials, which evaluated the safety and efficacy of SUTAB compared to FDA-approved preparations in 941 patients, including a traditional polyethylene glycol and ascorbate preparation (PEG-EA) for bowel cleansing prior to a colonoscopy.4