FDA to launch digital health, AI advisory committee

Today’s Big News

Oct 11, 2023

Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions


Orphan cell and gene therapies more likely to reach approval than larger drug pipeline: study


FDA to form advisory committee for digital health and AI


Akero's NASH miss drags a few peers down, spurring deja vu in long-challenging indication


EU order for Illumina to divest Grail could arrive within the week: reports

 

Featured

Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. Reata staffers who worked in roles that are already covered at Biogen are losing their jobs.
 

Top Stories

Orphan cell and gene therapies more likely to reach approval than larger drug pipeline: study

There’s a lot of risk inherent in biotech investment, but a new report suggests that an increasingly safe bet is one of the hottest areas of drug development: cell and gene therapy.

FDA to form advisory committee for digital health and AI

As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help them get deeper into the weeds.

Akero's NASH miss drags a few peers down, spurring deja vu in long-challenging indication

Things were going pretty well in the NASH landscape with Madrigal Therapeutics finally submitting a request to approve a treatment, but yesterday the space came crashing back down to reality with the failure of Akero Therapeutics’ med.

EU order for Illumina to divest Grail could arrive within the week: reports

Regulators in the EU are said to be on the verge of handing down an order forcing Illumina to divest Grail, according to multiple reports this week, following a yearslong antitrust battle that’s stretched across the Atlantic.

Novo Nordisk's unstoppable semaglutide clears kidney disease trial early on positive efficacy

For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.

As Federation folds, Kanvas Bio picks up the pieces to become clinical-stage company

As Federation Bio fades, Kanvas Biosciences has snapped up two of the biotech’s assets as well as its microbial library and the company’s chief scientific officer Lee Swem, Ph.D., to lead program development.

Labcorp launches tri-biomarker blood test to aid Alzheimer’s diagnosis

A year after unveiling its first blood test aimed at spotting the signs of a range of neurodegenerative diseases, Labcorp is ramping up its offerings in that realm with the launch of a new, Alzheimer’s disease-specific test.

GSK inks clutch of Zantac settlements as cancer-related litigation swells

GSK resolved a group of claims in California over heartburn medication Zantac. But the company is hardly out of the woods in the wide-ranging litigation.

Sana edits plans again, retreating from in vivo CAR-T delivery and laying off 29% of staff to cut costs

Sana Biotechnology is restructuring and narrowing its focus for the second time in 11 months. With its stock in the doldrums, the cell engineering biotech is pulling back from its in vivo delivery platform and reducing its head count by 29% to stretch its cash runway deeper into 2025.

Haemonetics offers $253M for sensor-equipped TAVR guidewire maker OpSens

In recent years, much of Haemonetics’ focus has been on building out a portfolio of devices for interventional cardiology procedures, and its latest M&A move continues that trend.

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

In a phase 3 trial testing the two forms over 24 weeks, the subcutaneous drug measured up to the IV version, Roche said. An approval for the subcutaneous version would open the door to broader usage.

FDA puts NJ drug ingredients maker Spectrum through the wringer in scathing Form 483

With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producing drug ingredients.
 
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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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