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Today's Rundown

Moderna probes reports of COVID-19 vaccine contamination in Japan
Ginger and Headspace plan merger to rapidly scale up digital mental health services
Seeking approval for a 3rd dose, Pfizer and BioNTech take their COVID-19 booster data to the FDA
Cassava defends Alzheimer's science after citizen petition raises 'grave concerns' about clinical studies
Johnson & Johnson touts antibody response for COVID-19 booster 8 months after original vaccination
Intuitive Surgical responds to FDA notice against unauthorized use of robots in mastectomies
Carbon Health scoops up 2 major clinic chains to expand primary care footprint
Sanofi, GSK and Seqirus prep for near-record flu shot sales as COVID's delta variant cooks up 'recipe for disaster'
Lilly doubles down on protein degradation, inking $35M deal with Lycia and promising $1.6B more
Hospitals' financial recovery stymied by July's COVID-19 resurgence, Kaufman Hall reports
FDA clears battery-free suction pump for surgical wound closures
COVID-19 tracker: Novo Nordisk requires vaccines at U.S. HQ; New York's death toll grows by 12,000

Featured Story

Moderna probes reports of COVID-19 vaccine contamination in Japan

By Kevin Dunleavy

It's been a relatively smooth ride for Moderna's global COVID-19 vaccine roll out. But on Wednesday, the company said it's investigating the possible contamination of one batch sent to Japan. Moderna said it is focusing its probe on its manufacturing partner in Spain, CDMO Rovi.

Ginger and Headspace plan merger to rapidly scale up digital mental health services

By Heather Landi

Marking the first mental health megamerger, teletherapy startup Ginger plans to merge with meditation app Headspace that will expand their combined reach to 100 million consumers.

Seeking approval for a 3rd dose, Pfizer and BioNTech take their COVID-19 booster data to the FDA

By Kevin Dunleavy

In a phase 3 trial, COVID-19 booster shots from Pfizer-BioNTech produced a more than threefold increase in antibody counts with no additional side effects. The companies will submit the data to the FDA in hopes of winning approval for booster use.

Cassava defends Alzheimer's science after citizen petition raises 'grave concerns' about clinical studies

By Annalee Armstrong

Small Alzheimer’s biotech Cassava Sciences is defending its work after a citizen petition filed with the FDA questioned the scientific integrity of the biotech’s clinical trials for simufilam and asked the agency to put them on hold. The whistleblower petition posted aftermarket Tuesday details “grave concerns about the quality and integrity" of the studies supporting the drug candidate.

Johnson & Johnson touts antibody response for COVID-19 booster 8 months after original vaccination

By Fraiser Kansteiner

Shortly after the U.S. telegraphed its booster plan for Pfizer and Moderna’s mRNA-based COVID-19 vaccines, Johnson & Johnson has rolled out trial results showing a follow-up dose of its vaccine boosts recipients' antibody responses.

Intuitive Surgical responds to FDA notice against unauthorized use of robots in mastectomies

By Andrea Park

Two years after the FDA first issued a safety notice outlining the lack of clinical evidence to support the use of robotic-assisted surgery systems in mastectomies, the agency is doubling down.

Carbon Health scoops up 2 major clinic chains to expand primary care footprint

By Heather Landi

Carbon Health, a primary care provider combining brick-and-mortar clinics with virtual services, bought two separate clinic chains to expand its national primary care footprint.

Sanofi, GSK and Seqirus prep for near-record flu shot sales as COVID's delta variant cooks up 'recipe for disaster'

By Noah Higgins-Dunn

Sanofi, GlaxoSmithKline and Seqirus say they're prepared to match last season's record supply of U.S. flu shots, gearing up to deliver more than 190 million doses. And as the troublesome delta variant wreaks havoc, a new CDC rule means Americans may be able to get their annual flu jab at the same time as a COVID booster.

Lilly doubles down on protein degradation, inking $35M deal with Lycia and promising $1.6B more

By Amirah Al Idrus

Eli Lilly is signing another protein degradation partner, signaling a growing commitment to the space, which seeks to tackle “undruggable” targets. The company is handing over $35 million and promising more than $1.6 billion in milestone payments to work with Lycia Therapeutics on up to five of these tricky targets in areas including immunology and pain.

Hospitals' financial recovery stymied by July's COVID-19 resurgence, Kaufman Hall reports

By Dave Muoio

The journey back to pre-pandemic financials hit a snag as rising COVID-19 cases and early signs of consumer hesitancy met persistent high expenses, according to Kaufman Hall's July report on national health systems.

FDA clears battery-free suction pump for surgical wound closures

By Conor Hale

Aatru’s disposable, three-ounce device is powered by a solid-state, chemical pump that traps air within it and provides suction for up to seven days.

COVID-19 tracker: Novo Nordisk requires vaccines at U.S. HQ; New York's death toll grows by 12,000

By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner

Novo Nordisk is requiring vaccinations at offices in New Jersey and D.C., and it's requiring masks regardless of vaccination status at other U.S. sites. New York has experienced many more deaths than previously disclosed, Gov. Kathy Hochul said. Plus more headlines.

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