No need to panic about COVID trial halts, FDA chief says. They show the system is working CMS expands list of telehealth services that can get Medicare reimbursement COVID-19 mRNA vaccine candidate from Sanofi and Translate protects mice, monkeys: study Regeneron, in the thick of COVID-19 fight, snags historic FDA approval for Ebola treatment States bracing for higher Medicaid enrollment, spending in 2021 Biopharma roundup: Public Citizen sues for Warp Speed contracts DNA maker Touchlight adds Lonza manufacturing vet as it swings at COVID-19 vaccine, cell and gene therapy markets A look at how Cigna's newly launched Evernorth is approaching innovation Roche hit by 'high-end' biosimilar attack as Ocrevus, Tecentriq bounce back from COVID slowdown Featured Story By Eric Sagonowsky Headlines about COVID-19 vaccine and drug trial pauses may ring alarm bells for millions of people watching their progress, but FDA Commissioner Stephen Hahn has another point of view. The breaks in the action actually show the development process is working as intended, Hahn told Bloomberg. read more |
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| | Researchers studying COVID-19 are using metabolomics to get closer to the phenotype Seven months since the rapid progression of COVID-19 (SARS-CoV-2), researchers across the globe have moved at a breathtaking pace to understand the progression of the disease and develop effective treatments. Join us for a panel discussion with practitioners who’ve incorporated metabolomics in a range of COVID-19 related studies as they share their perspectives on findings from recently or soon-to-be published studies. Register Today. | Top Stories By Robert King The Centers for Medicare & Medicaid Services added 11 new telehealth services that can get Medicare reimbursement and gave states new tools to help them expand telehealth access for Medicaid and the Children’s Health Insurance Program. read more By Arlene Weintraub Sanofi and its partner Translate Bio tested their mRNA COVID-19 vaccine candidate MRT5500 in mice and macaques and found that the animals developed neutralizing antibodies and a favorable T-cell response, they reported. A phase 1/2 trial is expected to start this quarter. read more By Eric Sagonowsky With the world focused on the fight against COVID-19, the scientific community just scored a big win in another infectious disease. The FDA approved the first treatment—Inmazeb from Regeneron—to treat Ebola in adults and children. read more By Paige Minemyer States are expecting are a pretty significant jump in Medicaid enrollment and spending for 2021, according to a new analysis. read more By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner Sanofi and its mRNA vaccine partner Translate Bio said their candidate protected mice and monkeys in an early study. Revenues for some Roche drugs started to recover amid the pandemic, while Public Citizen is suing for access to Operation Warp Speed contracts. read more By Kyle Blankenship With dozens of approvals expected in the coming years, the cell and gene therapy space has turned into a goldmine for contract manufacturers. But COVID-19 vaccines are also a potentially lucrative business for CDMOs, and one U.K. biotech has hired a new manufacturing head to help meet demand in both bustling markets. read more By Paige Minemyer The team at Cigna's newly launched subsidiary Evernorth is hard at work developing new solutions, and CEO David Cordani said they're taking a transparent approach. read more By Angus Liu Industry watchers weren’t exactly sure how copycats to Roche’s big three cancer drugs—Avastin, Rituxan and Herceptin—would fare when they landed in the U.S. Turns out, they've hit it big, driving sales for all three drugs way below industry watchers’ previous estimates. read more |