Baxter recall gets high-risk FDA tag

Today's Big News

Sep 16, 2022
 

AbbVie and Bristol Myers Squibb are laying off a total of 360 staffers on the West Coast: BMS is slimming down its workforce by 99 across two separate sites in San Diego County, while 261 employees will be let go from an AbbVie facility in Irvine, CA.  

Anywhere from 53% to 68% of US hospitals will end 2022 with operations in the red versus the 34% reported in 2019, according to new industry projections released by Kaufman Hall on behalf of the American Hospital Association.

After uncovering several patient safety and cybersecurity risks in many of its infusion pumps, Baxter is now recalling another product that works alongside those pumps, known as IV sets. As of this week, the FDA has categorized the recall as Class I, indicating high risk of patient injury or death. - Gabrielle Masson

 

Featured

 

AbbVie and BMS slash 360 jobs in California, the latest in a streak of biopharma layoffs

In separate Worker Adjustment and Retraining Notification (WARN) alerts filed this week, AbbVie and BMS let California know they plan to lay off 99 and 261 employees, respectively, by the end of November. For BMS, some of the layoffs are tied to a recent acquisition.
 
 
 
 

Top Stories

 

'Unsustainable' losses are forcing hospitals to make 'heart-wrenching' cuts and closures, leaders warn

A new report warns that anywhere from 53% to 68% of the nation's hospitals will finish 2022 with red operating margins. For systems large and small, this means service line closures or outright shutdowns that threaten patients' access to care, hospital leaders warned Thursday.
 
 
 

FDA slaps Class I tag on Baxter recall of Clearlink chemotherapy delivery sets

After uncovering a handful of patient safety and cybersecurity risks in many of its infusion pumps over the last year, Baxter has now begun a recall of yet another product that works alongside those pumps.
 
 
 

AstraZeneca's Alexion bet continues to pay off as danicopan improves hemoglobin levels in phase 3

AstraZeneca’s $39 billion acquisition of Alexion last year continues to look like money well spent. The latest good news is that the oral factor D inhibitor danicopan can improve hemoglobin levels when added to the approved drugs Ultomiris or Soliris.
 
 
 

Sanofi, AZ's blockbuster hopeful RSV med nears first approval as showdown with Pfizer, GSK looms

Friday, the European Medicines Agency’s human medicines committee, CHMP, vouched for approval of Beyfortus. The drug is in the running to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season and—if approved—would become the first single-dose passive immunization for the broad infant population.
 
 
 

Intellia's gene editing therapies both post early successes as evidence grows for CRISPR potential

Intellia Therapeutics is closing out the week strong, reporting good news for a duo of gene editing trials. Both are early-stage, but the company is already prepping to move the transthyretin amyloidosis therapy, NTLA-2001, into what it hopes will be a pivotal study.
 
 
 

Three-way merger nets $100M in VC cash to Galvanize pulsed electric fields for cancer, heart disease, bronchitis

The life science venture capital firm Apple Tree Partners has brought three of its portfolio companies together under a single banner to pursue energy therapies for chronic bronchitis, cardiac arrhythmias and solid tumors.
 
 
 

Summus and Boston Children's talk specialty virtual healthcare and bringing 2nd opinions to the world

Twenty percent of children have specialty health needs, but 39 million children in the U.S. live more than 80 miles from a pediatric subspecialist. Boston Children's Hospital teamed up with virtual specialist platform Summus Global earlier this year to expand virtual care for populations with complex healthcare needs.  
 
 
 

'The Top Line': What Merck trial flops at ESMO may portend, lessons from COVID for monkeypox test EUAs and more

This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA.
 
 
 

With 70% staff gone, Nordic Nanovector board members jump ship amid 'strategic review'

Nordic Nanovector is shedding board members as the Norwegian biotech continues to seek out options for survival in the wake of discontinuing its lymphoma trial.
 
 
 

Qiagen tapped to develop companion diagnostic for Neuron23's drug for Parkinson’s disease

As Neuron23's drug development continues, Qiagen will get started on building a companion diagnostic that’ll be able to predict how responsive Parkinson’s patients might be to an LRRK2 inhibitor—making it the first companion diagnostic developed for the neurodegenerative disease.
 
 
 

U.S. employers brace for healthcare costs to rise next 3 years

Employers face difficult challenges in the next few years. And with limited budgets, the challenge of making decisions that consider healthcare affordability and engagement is exponentially greater.
 
 
 
 
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'The Top Line': What Merck trial flops at ESMO may portend, lessons from COVID for monkeypox test EUAs and more

This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA.
 
 

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