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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.
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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#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
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+: 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.
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.
WASHINGTON — Both Democratic and Republican Senators who oversee federal spending seemed skeptical of proposed cuts to health research and public health in the White House’s budget, potentially teeing up a congressional package that ignores many of the administration’s most dramatic proposals for a second year.
During a Senate appropriations health subcommittee hearing Tuesday, lawmakers questioned health secretary Robert F. Kennedy Jr. on how his department could tackle chronic disease, smoking cessation, and cancer research with a proposed 2027 fiscal budget that would cut the department by 12%.
The request, which is broadly similar to what was proposed last year, includes deep cuts to the National Institutes of Health, the elimination of a health research agency, and the creation of a new agency devoted to chronic diseases called the Administration for a Healthy America.
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#AAN26: Roche’s multiple sclerosis pill delays relapse, but liver toxicity could need monitoring
STAT+: With successful trials, Roche takes its MS drug to regulators, but safety questions loom
STAT+: From Revolution Medicines, more strong data on KRAS drug and a glimpse of a ‘novel class’ beyond it
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Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
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Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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