BioWorld
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.@PalisadeBio backs away but others not ‘scarred’ of #FSCD bioworld.com/articles/734213 #biopharma #Crohns #IBD #gastrointestinal

Palisade backs away but others not ‘scarred’ of FSCD

Palisade Bio Inc.’s clearance from the U.S. FDA this summer to start a global phase II trial with PALI-2108 in ulcerative colitis (UC) called Ascentra UC – followed Sept. 23 by word from regulators...

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Another win in #IgAN as @Roche’s sefaxersen hits phase III goal (free w/one-time registration) bioworld.com/articles/734209 #biopharma #kidneydisease #clinic #nephrology @ionispharma

Another win in IgAN as Roche’s sefaxersen hits phase III goal

And the hits just keep on coming for the IgA nephropathy (IgAN) space, which until 2021, had no approved therapies for treating the progressive kidney disease. Five years later, there are six...

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Device sterilizer to pay $700K to settle emissions issue bioworld.com/articles/734309… #medtech @TheJusticeDept

Device sterilizer to pay $700K to settle emissions issue

Pending court approval, Steri-Tech Inc., a Puerto Rico-based contract medical device sterilizer, has agreed to pay $700,000 in civil penalties as part of a settlement resolving Clean Air Act violat...

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Anaconda snags $56M for work on tech platform for stroke bioworld.com/articles/734210 In this video Anaconda Biomed CEO Trent Reutiman talks about the company’s technology and its importance for stoke patients. He also discusses the IDE study and the financing. #medtech #financing #stroke #mechanicalthrombectomy
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.@HHSGov pondering reclassification of islet cells for T1 diabetes bioworld.com/articles/734308… #biopharma #diabetes @HRSAgov @US_FDA

HHS pondering reclassification of islet cells for T1 diabetes

Should unmodified islet cells from deceased donors be regulated as organs for transplant or as biological products? The U.S. Department of Health and Human Services (HHS) wants to know.

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Crispr on demand? Mutation-agnostic gene therapy trial nears clinic bioworld.com/articles/734211… #biopharma #science #Crispr #geneediting #raredisease #immune

Crispr on demand? Mutation-agnostic gene therapy trial nears clinic

Crispr genome editing could in theory be programmed to address any gene mutation, providing cures on demand for life-threatening inherited rare diseases in newborns. The challenge is to develop a...

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Otsuka, @ionispharma notch phase III win in FUS-ALS bioworld.com/articles/734212… #biopharma #ALS #PrecisionMedicine #neurology

Otsuka, Ionis notch phase III win in FUS-ALS

Otsuka Pharmaceutical Co. Ltd. and Ionis Pharmaceuticals Inc. reported positive phase III results from the Fusion study, showing statistically significant improvement in function and survival in...

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.@compassbio drops on FDA feedback for tovecimig in biliary cancer bioworld.com/articles/734261… #biopharma #biliarycancer

Compass drops on FDA feedback for tovecimig in biliary cancer

Shares of Compass Therapeutics Inc. (NASDAQ:CMPX) fell 27% as the company reported the U.S. FDA had recommended it conduct another trial before filing a regulatory submission for bispecific antibody...

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.@USGAO: @US_FDA coming up short on third-party review audits bioworld.com/articles/734260… #medtech #ThirdPartyReview

US GAO: FDA coming up short on third-party review audits

When it comes to auditing third-party organizations that review certain low- to moderate-risk medical devices, the U.S. FDA is coming up short. That’s according to a Government Accountability Office...

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Opposition growing to any new efforts to politicize @NIH grants bioworld.com/articles/734206… #biopharma #medtech #Congress #NIHgrants #OMB #TrumpAdministration @AppropsDems @ResearchAmerica @SenateApprops @SenatorCollins @UnitedforCures1 @WhiteHouse @WHOMB

Opposition growing to any new efforts to politicize NIH grants

U.S. congressional appropriators on both sides of the political divide are sending a strong message to the Trump administration: Keep politics out of the NIH grantmaking process.

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Lower-frequency signal: Viking conquest ahead in obesity? bioworld.com/articles/734202… #biopharma #obesity #GLP1 #GIP

Lower-frequency signal: Viking conquest ahead in obesity?

An expert with 35 years of experience in the obesity field called Viking Therapeutics Inc.’s prospect VK-2735 “among the best that we’ve seen,” and shares (NASDAQ:VKTX) reflected as much, closing...

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.@envisagenics, @Boehringer sign $1B #deal for RNA splicing platform (free w/one-time registration) bioworld.com/articles/734201… #biopharma #medtech #cancer #AI #deal #RNAsplicing #discovery

Envisagenics, Boehringer sign $1B deal for RNA splicing platform

A company that emerged with a new AI-powered platform nine years ago, and is focused on discovering drugs through alternative RNA splicing, has commanded a potential $1 billion or more from Boehrin...

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Dialybrid raises €15M for #Silkothane Arteriovenous Graft bioworld.com/articles/734205… #medtech #financing #kidneydisease

Dialybrid raises €15M for Silkothane Arteriovenous Graft

Dialybrid S.r.l. raised €15 million (US$17 million) in a series A funding round for its Silkothane Arteriovenous Graft, a hybrid vascular access graft for hemodialysis in patients with end-stage...

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Highlife secures $90M+ to advance its #TMVR system bioworld.com/articles/734204… #medtech #financing

Highlife secures $90M+ to advance its TMVR system

Highlife SAS raised €80 million (US$91.5 million) in a financing round for its transcatheter mitral valve replacement (TMVR) system. The funds will be used to accelerate commercial expansion of the...

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.@Novartis locks in preclinical RLT under $900M Boomray deal (free w/one-time registration) bioworld.com/articles/734203… #biopharma #deal #oncology #radiopharma #radioligand

Novartis locks in preclinical RLT under $900M Boomray deal

Novartis Pharma AG inked a potential $900 million deal to gain exclusive global rights to a preclinical radioligand therapy (RLT) from Boomray Pharmaceuticals Co. Ltd., as the Swiss big pharma staves...

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Uncertainty continues as @WuXi_AppTec haunted by listing bioworld.com/articles/734241 #biopharma @DeptofWar

Uncertainty continues as Wuxi Apptec haunted by listing

The U.S. legal saga continues for Wuxi Apptec. Rather than conceding after a federal district court granted the company a temporary reprieve in August from being designated as a “Chinese military...

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.@US_FDA briefing docs raise hopes for @GrailBio adcom bioworld.com/articles/734195 #medtech #adcom #cancer #diagnostic #Galleri

FDA briefing docs raise hopes for Grail adcom

Grail Inc. started the week on a high note with its stock (NASDAQ:GRAL) up as much as 38%, to a high of $111.49 on Sept. 21, from its Sept. 18 close of $80.77. Driving investors’ interest was the...

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.@US_FDA final rule provides flexibility for nonanimal testing bioworld.com/articles/734240 #biopharma #AnimalTesting #BiomedicalResearch #PreclinicalDevelopment @EMA_News @NIH

FDA final rule provides flexibility for nonanimal testing

Taking another step away from mandatory animal testing in preclinical drug development, the U.S. FDA is issuing a direct final rule updating its regulations to clarify that nonanimal methods can be...

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Field Medical reports positive data on fast #PFA catheter bioworld.com/articles/734194 #medtech #FieldForce #atrialfibulation

Field Medical reports positive data on fast PFA catheter

Field Medical Inc. reported positive 12-month results from the first-in-human Field Pulse trial of its Fieldforce pulsed field ablation (PFA) system in patients with atrial fibrillation. Data showed...

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