Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
The importance of artificial intelligence and machine learning continues to be acknowledged by drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been forged to deploy those tools.
The bad news is, yes, the U.S. is in for a second wave of COVID-19, which is expected to hit during the upcoming flu season. The good news is the nation is much better prepared for the next wave, the NIH’s Anthony Fauci told a House Energy and Commerce Committee Tuesday.
DUBLIN – Translate Bio Inc. is the first beneficiary to gain from Sanofi SA’s massive $11.7 billion addition to its balance sheet, following its recent disposal of its holdings in long-time partner Regeneron Pharmaceuticals Inc. Lexington, Mass.-based Translate Bio is getting $300 million up front, another $125 million in equity investment and up to $1.9 billion in milestones under a major expansion of an existing agreement with Paris-based Sanofi to develop mRNA-based vaccines for infectious disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunovative, Mirror Biologics, Karuna, Karyopharm, Marker, Myovant, Novaremed, Pharmacyclics, Polynoma, Reneo, Renibus, Santhera.