J&J unit lands in hot water over Impella tech

Today’s Big News

Oct 13, 2023

Pfizer takes aim at BMS' first-in-class Zeposia with FDA nod for ulcerative colitis drug Velsipity


Roche's BTK inhibitor may have reached 'holy grail' of brain penetration in phase 2 MS trial 


J&J’s Abiomed lands FDA warning letter over Impella heart pumps, software


High-flying Novo Nordisk again dials up its 2023 sales and profit expectations 


In conversation with GE HealthCare's chief AI officer, Parry Bhatia

 

Featured

Pfizer takes aim at BMS' first-in-class Zeposia with FDA nod for ulcerative colitis drug Velsipity

Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer.
 

Top Stories

Roche's BTK inhibitor may have reached 'holy grail' of brain penetration in phase 2 MS trial

Roche has claimed the latest phase 2 readout for its multiple sclerosis drug backs up the BTK inhibitor’s "best in disease" potential by achieving the "holy grail" in biopharma: crossing the blood-brain barrier.

J&J's Abiomed lands FDA warning letter over Impella heart pumps, software

Hot on the heels of handing down a trio of Class I labels this year to safety events concerning certain Abiomed heart pumps, the FDA has gone a step further in its crackdown.

High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again.

In conversation with GE HealthCare's chief AI officer, Parry Bhatia

Parminder “Parry” Bhatia was named chief AI officer of GE HealthCare earlier this year after six years at Amazon and AWS working on its machine learning and generative AI programs.

Relay blames IRA for pause in plans to win approval in rare cancer, adding laps to its race to market

Relay Therapeutics has decided to extend its race to market. Citing the impact of the Inflation Reduction Act (IRA), the biotech has paused plans to bring lirafugratinib to market in a rare cancer, choosing instead to pursue a larger, tumor-agnostic opportunity.

Amylyx's ALS drug Albrioza rebuffed by EU regulator—again

Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

Cassava implies 'short-sellers' to blame for leaking CUNY report alleging scientific misconduct

CUNY is once again pinning its misfortunes on short-sellers, suggesting they were involved in leaking a CUNY report outlining scientific misconduct from a key scientific adviser.

Sotio stops IL-15 trials as cytokine falls short in solid tumors, dealing fresh blow to once-hot mechanism

Sotio Biotech has dealt another blow to attempts to establish cytokines as a cornerstone of cancer care, scrapping ongoing studies of its IL-15 superagonist after seeing insufficient efficacy in the clinic.

Masimo wins de novo clearance to add oxygen reserve index calculations to pulse oximeters

The new parameter has been available in Europe for a couple of years, since Masimo earned CE mark clearance in 2021 for a patient monitoring device with 12 sensors that included one to calculate what the company has dubbed ORi.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Unraveling Alzheimer's disease treatments

In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease.

 

Resources

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Ensuring a Reliable Biopharmaceutical Supply in the EU

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Biology Informatics Solutions Brochure

From Assay Development Through Large Molecule Development. Streamline your R&D workflows and gain valuable insights with our Biology Solutions Brochure. Download now to discover how to control your laboratory workflows across various assay techniques, modalities, and data types.
eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
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Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.
 

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