Samsung smartwatches snag sleep apnea nod

Today’s Big News

Feb 12, 2024

Biotech bankruptcies hit 10-year peak in 2023


In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’


Samsung scores FDA de novo nod for sleep apnea feature on Galaxy smartwatches


Pfizer enlists Queen, Einstein and more for Super Bowl ad showing its role in the history of science  


Gilead pays $4.3B for CymaBay, the biotech that never gave up on liver disease med


Masimo touts study showing its pulse oximeters are effective across skin tones regardless of perfusion levels

 

Featured

Biotech bankruptcies hit 10-year peak in 2023

More biotech companies filed for bankruptcy in 2023 than any year since 2010, underscoring a brutal year defined by layoffs, company closures and pipeline reprioritizations.
 

Top Stories

In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’

Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection. But the first FDA-approved oral eosinophilic esophagitis therapy comes with a limitation.

Samsung scores FDA de novo nod for sleep apnea feature on Galaxy smartwatches

Amid rumors that Apple is in the process of adding a sleep apnea detection feature to its namesake wearables, Samsung has beat it to the punch.

Pfizer enlists Queen, Einstein and more for Super Bowl ad showing its role in the history of science

Pfizer has touched down at the Super Bowl. The Big Pharma ran its “Here’s to Science” ad at the event, framing its work to “outdo cancer” as part of a history of breakthroughs dating back to Hippocrates.

Gilead pays $4.3B for CymaBay, the biotech that never gave up on liver disease med

Gilead is bolstering its liver disease portfolio with the $4.3 billion acquisition of CymaBay Therapeutics, specifically for the primary biliary cholangitis med seladelpar.

Masimo touts study showing its pulse oximeters are effective across skin tones regardless of perfusion levels

About a week after the FDA convened another meeting to discuss strategies for reducing racial biases in widely available pulse oximetry technology, Masimo has released new study data suggesting that such measures won’t be needed for its own blood oxygen sensors.

CSL's 'most ambitious' phase 3 trial ends in failure for heart attack drug

CSL’s largest-ever trial has ended in failure, as the Australian pharma revealed that its cholesterol efflux enhancer was unable to reduce the risk of heart attacks.

PTC's Emflaza to face generics this month after Aurobindo's final FDA nod

After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.

Medicxi merges 6 dermatology biotechs into one, adds $100M funding for launch

What do you get when you merge six dermatology disease-focused biotechs into one? Medicxi plans to find out.

CMR Surgical adds new tissue imaging tech to Versius robot

“This is the most significant update of Versius since it launched back in 2019,” CEO Supratim Bose said in the company’s announcement.

Gritstone's BARDA-funded COVID vaccine faces manufacturing-related trial delay

Gritstone opted to kick off the phase 2b study in the fall instead of this quarter to "allow use of fully GMP-grade raw materials," according to the company. The move is meant to hopefully increase the trial's regulatory value.

Researchers show plugging a nanopore sensor with gold could help detect ovarian cancer

Researchers at Virginia Commonwealth University have shown that a urine-based test could have the potential to become a simplified screening method.

AstraZeneca ‘body checks’ cancer in NHL-partnered screening push

AstraZeneca is working with the National Hockey League (NHL) to encourage people to “Get Body Checked Against Cancer.” The campaign is designed to encourage sports fans to ask their doctors about available cancer screenings and address low awareness of asymptomatic detection recommendations.
 
Fierce podcasts

Don’t miss an episode

‘The Top Line’: The most anticipated drug launches of 2024

This week on “The Top Line,” we explore the most anticipated drug launches of 2024. Editor-in-Chief Ayla Ellison engages in a conversation with Fierce Pharma Marketing Senior Editor Ben Adams about the drugs likely to launch this year with the most significant sales potential by 2028.
 

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

This paper offers a detailed review of key events and developments in the oncology market during 2023.  It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more.

Whitepaper

Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

 

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