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292,732 Results for "transperfect trial interactive".
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Business
Gedeon Richter Selects Trial Interactive for Clinical Trial Management
TransPerfect Life Sciences, a leading global provider of solutions for product development and launch for the biopharmaceutical industry, announced that Gedeon Richter selected Trial Interactive’s award-winning eTMF platform and TI Collaborate eClinical solution for its upcoming clinical trials.
March 25, 2024
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3 min read
Pharm Country
TransPerfect Life Sciences and Innovaderm Research Expand Trial Interactive Partnership
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Innovaderm will scale their implementation of Trial Interactive to further enable and optimize remote clinical operations.
February 15, 2022
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4 min read
FDA
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.
January 7, 2025
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3 min read
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Heather McKenzie
Business
Trials and Capital: Women’s Health and APAC’s Healthcare Revolution
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
January 2, 2025
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1 min read
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Lori Ellis
ALS
HEALEY ALS Trial Serves Up More Disappointment as Denali, AbbVie/Calico Fail
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in ALS overall.
January 10, 2025
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5 min read
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Heather McKenzie
Clinical research
Insilico Aces Second Mid-Stage IPF Trial in a Row
In a small Phase IIa trial, Insilico’s generative AI-designed idiopathic pulmonary fibrosis drug improved lung function and was well-tolerated across all dosing groups.
November 12, 2024
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2 min read
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Heather McKenzie
Gene therapy
Patient Death in Rett Syndrome Trial Forces Neurogene to Drop High-Dose Arm
Despite the death, the FDA has allowed Neurogene to forge ahead with the Phase I/II Rett syndrome trial, but using only the lower 1E15 vg dose of its investigational gene therapy NGN-401.
November 22, 2024
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2 min read
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Tristan Manalac
Biotech Beach
ACTG Announces Launch of Clinical Trial Evaluating Drug-Drug Interaction in Shortened Tuberculosis Regimen Among People Living with HIV
ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of study A5406 (Pharmacokinetics and Safety of Double-dose Dolutegravir When Used with Rifapentine for HIV-associated Tuberculosis).
February 14, 2024
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3 min read
Layoffs
Compass Delays Pivotal Trial Readouts for Psilocybin in Depression, Lays Off 30% of Staff
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression.
October 31, 2024
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2 min read
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Heather McKenzie
Bladder Cancer
Gilead Withdraws ADC Trodelvy in Bladder Cancer After Trial Failure
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.
October 18, 2024
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2 min read
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Annalee Armstrong
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