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Today's Rundown

Gilead pulls 2 cancer accelerated approvals as changing lymphoma landscape disrupts confirmatory trial
1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial
Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth
Casana lands $30M to take its heart-scanning smart toilet seat to the FDA
Does the world need more COVID-19 vaccines? These companies think there's still room for improvement
Philips prepares for rocky start to 2022 after ventilator recall knocks €719M off 2021 income
With omicron on the prowl, FDA extends inspection pause into February
Medtronic snags another Class I recall, this time for its artery-clearing HawkOne system
Merck's chronic cough med gets a nay from FDA, potentially clearing first-to-market path for Bellus
FDA authorizes Mammoth Bio’s high-throughput CRISPR test for COVID-19
Cigna study: Virtual care can reduce unnecessary ER, urgent care visits by 19%
On second thought, Oncopeptides decides not to give up on Pepaxto in the U.S., but won't say why
The eviction moratorium in New York has ended. Here's how one practice is prepared to serve affected patients
Fluidigm scores $250M investment in microfluidics tech and a corporate makeover to boot

Featured Story

Gilead pulls 2 cancer accelerated approvals as changing lymphoma landscape disrupts confirmatory trial

By Angus Liu

Back in 2014, Gilead Sciences’ Zydelig became the first PI3K inhibitor cleared by the FDA for certain B-cell blood cancers. Fast forward to today, and the company has found itself withdrawing two indications gained under the accelerated approval pathway as more treatments have become available.

1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial

By Nick Paul Taylor

Viking Therapeutics thought it was running a phase 1b clinical trial. The FDA thought otherwise, leading it to slap a clinical hold on the metabolic disorder study while Viking does the preclinical work needed to enter phase 2.

Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth

By Heather Landi

Digital health investment around the world hit an all-time high of $57.2 billion in funding in 2021, fueled by the growing need to provide digital solutions and delivery models to patients during the pandemic.

Casana lands $30M to take its heart-scanning smart toilet seat to the FDA

By Conor Hale

Casana aims to provide people with a regular heart health scan without intruding on their daily routine, with electronic sensors for logging heart rate and blood pressure built directly into the cushion.

Does the world need more COVID-19 vaccines? These companies think there's still room for improvement

By Annalee Armstrong,Kyle LaHucik

The ultimate COVID-19 vaccine will be able to tackle all emerging coronavirus strains, easy to store and quick to manufacture. And yes, there's still time for the stragglers who were beaten to the punch by Pfizer, BioNTech and Moderna—at least according to the companies still trying to get in line.

Philips prepares for rocky start to 2022 after ventilator recall knocks €719M off 2021 income

By Andrea Park

Recovery from Philips’ difficult 2021 will require at least static sales growth, since, for the full year, the company reported a year-over-year sales decline of 1%.

With omicron on the prowl, FDA extends inspection pause into February

By Fraiser Kansteiner

The FDA has extended its pause on certain inspection activities as it keeps tabs on the COVID-19 pandemic and the spread of omicron, the regulator said late last week. While the agency will continue to perform mission-critical inspections at home and abroad, the FDA is drawing out the pause on domestic surveillance inspections through Feb. 4, with the goal to restart those activities “as soon as safely possible.”

Medtronic snags another Class I recall, this time for its artery-clearing HawkOne system

By Conor Hale

The recall, launched by the medtech giant in early December 2021, covers more than 95,000 devices distributed in the U.S. since 2018.

Merck's chronic cough med gets a nay from FDA, potentially clearing first-to-market path for Bellus

By Kyle LaHucik

The FDA rejected Merck's chronic cough treatment, potentially setting up more breathing room for competitor Bellus Health in a first-to-market battle.

FDA authorizes Mammoth Bio’s high-throughput CRISPR test for COVID-19

By Conor Hale

While Mammoth has focused on tailoring its reagents to react with the coronavirus’ genome, Agilent has worked to deliver high-speed liquid handling hardware with its Bravo BenchCel DB workstation platform.

Cigna study: Virtual care can reduce unnecessary ER, urgent care visits by 19%

By Paige Minemyer

Integrating virtual care can save the healthcare system significant amounts of money, as well as avoid unnecessary visits to the emergency department or urgent care center, according to a new study from Cigna.

On second thought, Oncopeptides decides not to give up on Pepaxto in the U.S., but won't say why

By Kevin Dunleavy

Oncopeptides has changed its mind. Just three months ago, the company said it would pull its multiple myeloma treatment Pepaxto off the market and completely restructure. Now it says it's keeping its bid for full FDA approval alive—and it's not explaining why.

The eviction moratorium in New York has ended. Here's how one practice is prepared to serve affected patients

By Anastassia Gliadkovskaya

The practice works with Phreesia, a patient intake software, to screen for social determinants. It also refers patients in need to community partners who do work in areas like housing or food security.

Fluidigm scores $250M investment in microfluidics tech and a corporate makeover to boot

By Andrea Park

By the end of the first quarter of this year, Fluidigm will be nearly unrecognizable.

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Featured Story

Gilead pulls 2 cancer accelerated approvals as changing lymphoma landscape disrupts confirmatory trial

Top Stories

1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial

Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth

Casana lands $30M to take its heart-scanning smart toilet seat to the FDA

Does the world need more COVID-19 vaccines? These companies think there's still room for improvement

Philips prepares for rocky start to 2022 after ventilator recall knocks €719M off 2021 income

With omicron on the prowl, FDA extends inspection pause into February

Medtronic snags another Class I recall, this time for its artery-clearing HawkOne system

Merck's chronic cough med gets a nay from FDA, potentially clearing first-to-market path for Bellus

FDA authorizes Mammoth Bio’s high-throughput CRISPR test for COVID-19

Cigna study: Virtual care can reduce unnecessary ER, urgent care visits by 19%

On second thought, Oncopeptides decides not to give up on Pepaxto in the U.S., but won't say why

The eviction moratorium in New York has ended. Here's how one practice is prepared to serve affected patients

Fluidigm scores $250M investment in microfluidics tech and a corporate makeover to boot