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Today's Rundown

Amid White House feud, FDA raises vaccine rules that would nix a pre-election COVID shot
BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine
5 ways medical practices can restore patient visit volumes amid a pandemic: report
Pfizer-BioNTech, Regeneron sued for patent infringement with COVID-19 products
How industry groups say Medicare payment rule proposals will hurt practices already besieged by COVID-19
After ERT hit by ransomware attack, the trial company kicks out old chief amid delayed COVID-19 work
Oxford Biomedica earns U.K. nod for 4th manufacturing suite to boost COVID-19 production
Novo Nordisk debuts animated Rybelsus ad after COVID-19 nixed film shoot
Biopharma roundup: FDA posts vaccine rules despite White House feud; Saliva tests take off in the US: report
Healthcare roundup: HCSC to offer $240M in premium relief to fully insured customers
Walden Biosciences launches with $51M and a 2-pronged approach to 'completely transform' kidney disease

Featured Story

Amid White House feud, FDA raises vaccine rules that would nix a pre-election COVID shot

By Eric Sagonowsky

A weeks-long feud between the White House and FDA over COVID-19 vaccine guidelines took another turn Tuesday as the agency released vaccine recommendations despite efforts by the White House to keep them under wraps. The FDA advises two months of monitoring after patients' final doses, which could thwart President Donald Trump's desire for a shot before the election.

BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine

By Nick Paul Taylor

BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process.

5 ways medical practices can restore patient visit volumes amid a pandemic: report

By Tina Reed

In a report out this week, MGMA released key best practices for practices to follow to help restore patient volumes and stabilize financial footing based on 2019 data from more than 1,500 organizations.

Pfizer-BioNTech, Regeneron sued for patent infringement with COVID-19 products

By Angus Liu

As Regeneron grabs the limelight for treating President Donald Trump with its experimental COVID-19 antibody cocktail, the company now finds itself alongside vaccine developers Pfizer and BioNTech on the defensive in a lawsuit that claims their coronavirus products infringe upon a patent by Allele Biotech.

How industry groups say Medicare payment rule proposals will hurt practices already besieged by COVID-19

By Heather Landi

Proposed policy changes for Medicare payments for 2021 could hurt physician practices already experiencing severe reductions in revenue during the COVID-19 pandemic, according to several industry groups.

After ERT hit by ransomware attack, the trial company kicks out old chief amid delayed COVID-19 work

By Ben Adams

Clinical trial health tech firm eResearchTechnology is getting a new CEO in the same week a report by The New York Times said its work on COVID-19 treatments was delayed due to a cyberattack.

Oxford Biomedica earns U.K. nod for 4th manufacturing suite to boost COVID-19 production

By Kyle Blankenship

Among the contract manufacturers enjoined in the race for a COVID-19 vaccine, U.K.-based Oxford Biomedica has forged a close relationship with AstraZeneca given its choice location. Now, the company is one step closer to running at full speed with the U.K.'s nod for a new production suite.

Novo Nordisk debuts animated Rybelsus ad after COVID-19 nixed film shoot

By Sharon Klahr Coey

Novo Nordisk’s first DTC ad for Rybelsus shows an animated world that looks a lot better than the real one currently does. But the sunny cartoon world wasn't Novo's original plan.

Biopharma roundup: FDA posts vaccine rules despite White House feud; Saliva tests take off in the US: report

By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner

The FDA is working to prevent interference in its vaccine reviews, Commissioner Hahn said. The agency on Tuesday released tougher guidelines for vaccine authorization. Saliva testing is gaining traction in the U.S. China is angling for WHO to review its vaccines. And eResearchTechnology switched CEOs after a ransomware attack stalled COVID trials.

Healthcare roundup: HCSC to offer $240M in premium relief to fully insured customers

By Healthcare Staff

Follow along with the latest COVID-19 news straight from the Fierce Healthcare team.

Walden Biosciences launches with $51M and a 2-pronged approach to 'completely transform' kidney disease

By Amy Sokolow

In the U.S., about 37 million people live with kidney disease, which is more than 1 in 7 American adults. But Blaine McKee, the CEO of the newly unveiled Cambridge, MA, startup Walden Biosciences, hopes to change that.

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