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Lilly’s new obesity pill passes heart safety test in diabetes

The findings, which come amid FDA scrutiny of Foundayo’s safety, will enable Lilly to seek a new clearance in diabetes.

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The findings, which come amid FDA scrutiny of Foundayo’s safety, will enable Lilly to seek a new clearance in diabetes.

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#AAN26: Roche’s multiple sclerosis pill delays relapse, but liver toxicity could need monitoring

#AAN26: Roche’s multiple sclerosis pill delays relapse, but liver toxicity could need monitoring

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Roche’s multiple sclerosis pill more than doubled patients’ relapse-free interval compared with Sanofi’s marketed MS pill Aubagio, according to data presented late on Tuesday.

The drug, a BTK inhibitor called fenebrutinib, demonstrated “the lowest relapse …​ ​Read More

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STAT+: With successful trials, Roche takes its MS drug to regulators, but safety questions loom

The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  

Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.

While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  

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The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  

Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.

While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  

Continue to STAT+ to read the full story…

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STAT+: From Revolution Medicines, more strong data on KRAS drug and a glimpse of a ‘novel class’ beyond it

SAN DIEGO — Revolution Medicines is already cooking up the next iteration of RAS inhibiting drugs.

At the American Association of Cancer Research annual meeting here, the company is the talk of the town for the clinical trial success of daraxonrasib, their next generation targeted therapy, in advanced pancreatic cancer. And while the company presented more data on that drug on Tuesday, showing promising first line and combination data on daraxonrasib, scientists also showed in another session intriguing preclinical data on a completely new compound that may represent what comes after their current lineup.

That drug, currently called RM-055, is what RevMed’s CEO Mark Goldsmith is calling an entirely “novel class of catalytic inhibitors.” These are targeted therapies that not only block the RAS signaling that drives cancer, but molecularly turn the cancer protein off.  

Continue to STAT+ to read the full story…

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SAN DIEGO — Revolution Medicines is already cooking up the next iteration of RAS inhibiting drugs.

At the American Association of Cancer Research annual meeting here, the company is the talk of the town for the clinical trial success of daraxonrasib, their next generation targeted therapy, in advanced pancreatic cancer. And while the company presented more data on that drug on Tuesday, showing promising first line and combination data on daraxonrasib, scientists also showed in another session intriguing preclinical data on a completely new compound that may represent what comes after their current lineup.

That drug, currently called RM-055, is what RevMed’s CEO Mark Goldsmith is calling an entirely “novel class of catalytic inhibitors.” These are targeted therapies that not only block the RAS signaling that drives cancer, but molecularly turn the cancer protein off.  

Continue to STAT+ to read the full story…

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