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11

Moderna files for U.S. vaccine authorization, will seek EU nod

Moderna Inc. applied for U.S. emergency authorization for the company’s Covid-19 vaccine after full results from a late-stage study showed mRNA-1273 was 94.1% effective with no serious safety concerns.

13

COVID-19 R&D Alliance launches trial of Amgen, UCB, Takeda drugs

Amgen, UCB and Takeda launched a global trial to identify whether any of three different drugs can reduce the severity of Covid-19 in hospitalized patients by moderating the immune system’s response to the disease.

14

U.S. reports over 10,000 coronavirus deaths for week ended Nov. 29

The United States recorded 10,000 coronavirus deaths and more than 1.1 million new cases for the week ended Nov. 29, although state and health officials said the Thanksgiving holiday likely caused numbers to be under-reported.

15

Moderna’s Covid-19 Vaccine Heads to FDA for Emergency Use Authorization

Moderna announced plans to submit the company’s request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for the Covid-19 vaccine mRNA-1273 on Nov. 30.

16

With vaccines within reach, U.S. braces for post-Thanksgiving coronavirus surge

After a Thanksgiving weekend when the number of people traveling through U.S. airports reached the highest total since mid-March, a top government official said some Americans could begin receiving coronavirus vaccinations before Christmas.

17

Airlines Gear Up to Fly Covid-19 Vaccines to U.S. Distribution Sites

With both Pfizer-BioNTech and Moderna’s Covid-19 vaccines at the U.S. Food and Drug Administration awaiting potential Emergency Use Authorization (EUA), airlines are preparing their cargo operations to ship the vaccines.

18

Rhythm Receives FDA Approval for Imcivree in Certain Patients with Obesity

The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals’ Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.