To view this email as a web page, click here

Today's Rundown

Featured Story

Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data

Eli Lilly is hustling to the FDA with its antibody therapy for a speedy emergency use authorization as it also reveals new data for a combo therapy.

read more

Top Stories

Forget October. Warp Speed chief says first COVID shot data—from Pfizer and Moderna—won't appear till later this year

President Donald Trump has repeatedly said a COVID-19 vaccine could be available around the election, but developments in recent days have all but nixed that possibility. Instead, officials are signaling a timeline of data releases that begins in November and continues into 2021, with emergency reviews along the way.

read more

Nearly 8M Americans in danger of losing job-based insurance, Commonwealth Fund analysis finds

A new Commonwealth Fund study estimates as many as 7.7 million Americans could lose their employer-sponsored insurance due to job losses sparked by the COVID-19 pandemic.

read more

Gilead Sciences sends additional doses of COVID-19 therapy remdesivir to EU amid shortages

As one of few COVID-19 therapeutics with global regulators on board, Gilead Sciences' remdesivir saw immediate U.S. demand that has somewhat tapered off in recent months. But in the EU, some nations have seen spot shortages, and Gilead is stepping in with more supply. 

read more

Regeneron execs go on a whirlwind media tour after Trump takes COVID-19 antibody cocktail

Just days after Regeneron published early data on its COVID-19 antibody cocktail, the White House announced that President Donald Trump was taking it. What followed was a run-up in Regeneron shares, repeated shout-outs from the president and a fair share of media appearances for the company's already high-profile execs.

read more

Hospitals that don't submit daily COVID-19 data could lose participation in Medicare, Medicaid

Hospitals currently not reporting daily COVID-19 information could find themselves losing participation in Medicare and Medicaid.

read more

Supply snags at Roche hit COVID-19 testing in the U.K.: Reuters

A disruption in the supply chain of Roche’s U.K. division has constricted its shipments of COVID-19 tests and other diagnostic supplies throughout the country, according to a report from Reuters.

read more

Medtech CEOs discuss returning procedure volumes, V-shaped recoveries and 'the new normal' after COVID-19

It’s an urgent question not only for the medtech community and its patients, but one described as “top of mind" for the healthcare industry at large: How will surgical procedures recover and evolve as the country continues to navigate the COVID-19 pandemic?

read more

CDRH's Shuren warns of the 'canary in the coal mine' in the FDA's COVID-19 response

The FDA has found itself between overwhelming public demand for COVID-19 diagnostics, ventilators and other devices on one side, and a tsunami of companies submitting over 1,200 products for review on the other—and the workload is beginning to take its toll.

read more

Biopharma roundup: Gilead ships extra remdesivir doses to shortage-hit EU; Roche hits U.K. testing supply snag: report

Gilead shipped extra remdesivir doses to the EU after reports of shortages. Roche hit testing supply snags in the U.K, Reuters reports. Regeneron has been riding a media wave ever since President Trump received the drugmaker's antibody cocktail. Plus, Nephron got hit with a warning letter for promoting an asthma drug to treat COVID-19 symptoms.

read more

2020 breaks record in digital health investment with $9.4B in funding

This year will be the largest funding year for digital health to date, with $9.4 billion invested up through the third quarter. Here's how much the sector is expected to hit by the end of the year.

read more

Israel's Mapi Pharma sets aside manufacturing space to boost country's COVID-19 jab supply

With the end of the year fast approaching, nations are looking for ways to secure enough supply of a potential COVID-19 vaccine to meet demand from their citizens. For Israeli drugmaker Mapi, meeting that demand means dedicating space at a Jerusalem facility to chip in on the effort. 

read more

Chinese COVID-19 vaccine trial reports falling antibody titers

The Chinese Academy of Medical Sciences has presented phase 1 data on its inactivated SARS-CoV-2 vaccine. The readout suggests the vaccine is safe and triggers an immune response, although a drop in neutralizing antibody titers from Day 14 to Day 28 is a potential cause for concern.

read more