What to expect as the FDA reins in lab-developed tests

Today’s Big News

Oct 10, 2023

New Biogen research chief Grogan looks to apply biotechs’ scrappiness to a pharma in flux   


Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears 


The road ahead as FDA tries to tame lab-developed tests 


Novartis cuts depression study, nearly erasing $210M Cadent acquisition from pipeline

 

Featured

New Biogen research chief Grogan looks to apply biotechs’ scrappiness to a pharma in flux

Biogen's new research chief Jane Grogan is looking to bring her recent biotech chops to a Big Pharma that's recalibrating. Her appointment follows a summer marked by layoffs, restructuring and a big-time acquisition.
 

Top Stories

Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda.

The road ahead as FDA tries to tame lab-developed tests

ANAHEIM, California—At the MedTech Conference, an FDA official described the tasks ahead as the agency moves to increase its oversight of lab-developed tests.

Novartis cuts depression study, nearly erasing $210M Cadent acquisition from pipeline

Novartis rolled the dice in 2020 with a $210 upfront acquisition of long-time neuroscience partner Cadent Therapeutics. But the bet seems to have come up empty, as the Swiss pharma discontinues a mid-phase major depressive disorder program.

Akero's stock sinks as midphase cirrhosis fail sparks flash NASH crash

Akero Therapeutics’ nonalcoholic steatohepatitis (NASH) candidate has flunked a key test. The failure of FGF21 analog efruxifermin to significantly reduce fibrosis in cirrhotic NASH patients sent Akero’s stock tumbling—and caused fallout that dragged a rival’s share price down, too.

Medtronic target EOFlow faces preliminary injunction as Insulet argues trade secrets case

Ahead of a planned acquisition by Medtronic, it’s not all smooth sailing for insulin patch pump maker EOFlow.

Bayer christens $250M cell therapy 'launch facility' in Berkeley

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.

Athersys inches closer to bankruptcy as stroke cell therapy fails interim analysis

After tweaking a phase 3 clinical trial for the ischemic stroke cell therapy MultiStem with the blessing of the FDA and moving forward with an enrollment goal of 300 patients, Athersys now reports that the sample size is insufficient to achieve the primary endpoint.

Philips connects Capsule’s vendor-neutral data collection with its centralized patient monitoring hub

More than two years after purchasing the medical data aggregator Capsule Technologies, Philips is launching a newly integrated information platform capable of connecting nearly all of the devices used across a hospital.

HistoSonics beams up FDA de novo nod for liver tumor-destroying ultrasound

For the first time, the FDA has given the green light to histotripsy technology, which uses focused ultrasound waves to noninvasively destroy a tumor.

Amid Eylea showdown, Roche's Vabysmo shows durability in retinal vein occlusion

Closing in on a likely approval to treat retinal vein occlusion, Roche has presented long-term data that show Vabysmo can maintain visual gains in the indication with a dosing duration stretched for some patients to as long as once every four months
 
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Resources

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Biology Informatics Solutions Brochure

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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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