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Today's Rundown

Judge denies Pfizer's request to run 2 programs to subsidize patients for expensive heart drug
Biden admin releases surprise billing rule detailing arbitration process
UPDATED: Merck's oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA
Eli Lilly's Olympics campaign rewind: Leverage pandemic's focus on health to assert its brand and assert its point of view
Siemens nets groundbreaking FDA clearance for photon-counting CT scanner
Here's what major national payers are offering in Medicare Advantage for 2022
Sophia Genetics teams up with OncoDNA to automate tumor profiling
Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant
HRSA opens applications for $22.5B of new provider pandemic relief funds

Thank you to IQVIA Biotech for sponsoring Fierce Biotech's
2021 Fierce 15 editorial feature.

Featured Story

Judge denies Pfizer's request to run 2 programs to subsidize patients for expensive heart drug

By Kevin Dunleavy

In ruling in favor of the Department of Health and Human Services, Southern District of New York judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually. The ruling blunts Pfizer's effort to roll back the anti-kickback policies of the U.S.

Biden admin releases surprise billing rule detailing arbitration process

By Robert King

The Biden administration released an interim final rule that outlines the independent resolution process that will handle disputes over out-of-network charges.

UPDATED: Merck's oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA

By Nick Paul Taylor

The wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring it to stop the study and race to get emergency use authorization.

Eli Lilly's Olympics campaign rewind: Leverage pandemic's focus on health to assert its brand and assert its point of view

By Beth Snyder Bulik

Eli Lilly signed on to be an Olympic sponsor for the Tokyo Games in 2019. When the pandemic postponed the Games, the pharma industry dove into researching vaccines and therapies and attention dropped for the Games and planning. But as successful vaccines and monoclonal antibody treatments came to market, Lina Polimeni, Lilly’s chief media officer, noticed consumers were suddenly picking and choosing pharma brands.

Siemens nets groundbreaking FDA clearance for photon-counting CT scanner

By Conor Hale

The Naeotom Alpha’s detectors are sensitive enough to measure X-rays individually, compared to current systems, which gauge the total sum of energy passing through a patient’s body.

Here's what major national payers are offering in Medicare Advantage for 2022

By Paige Minemyer

Medicare Advantage open enrollment begins Oct. 15, and major national payers are outlining their plans for the coming year.

Sophia Genetics teams up with OncoDNA to automate tumor profiling

By Andrea Park

By combining their respective software tools, Sophia and OncoDNA will create a platform that automates the entire tumor profiling process, from identifying genetic variants in sequencing data all the way through suggesting the most effective treatments for those variants.

Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant

By Kevin Dunleavy

COVID-19 vaccine producer Moderna and Japanese partner Takeda have concluded that “human error” caused the presence of metallic particles in vials discovered five weeks ago in Japan. The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The particles were stainless steel and resulted from mistakes made during a production-line changeover, the 16-page report said.

HRSA opens applications for $22.5B of new provider pandemic relief funds

By Dave Muoio

The distribution will recoup providers whose revenues and expenses were impacted by COVID-19, with a particular focus on smaller, rural facilities. The online application portal will be open through Oct. 26.

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