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BioWorld - Friday, December 26, 2025
Home » Topics » Clinical

Clinical
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IMV’s phase II ovarian cancer data trend positive while the stock reverses

Feb. 25, 2020
By Lee Landenberger
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
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CRT20

Data underscores benefits of Biotronik’s ultrathin strut Orsiro DES

Feb. 25, 2020
By Meg Bryant
NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up.
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CRT20

Cardiovalve wins FDA breakthrough nod for tricuspid valve replacement technique

Feb. 24, 2020
By Meg Bryant
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
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NGM studios’ top-line phase II NASH premiere whets appetite for Alpine 2/3 sequel

Feb. 24, 2020
By Randy Osborne
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
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Trisalus initiates study for delivery tech to help patients with pancreatic tumors

Feb. 20, 2020
By Liz Hollis
Trisalus Life Sciences Inc., of Westminster, Colo., reported the start of a clinical trial assessing a treatment that combines its intravascular, tumor-directed proprietary Pressure-Enabled Drug Delivery (PEDD) approach with standard-of-care systemic chemotherapy.
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VMAT2 carry-through brings Waterloo for Austedo TS bid by Teva

Feb. 20, 2020
By Randy Osborne
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
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Zelira’s medicinal cannabis therapy meets primary endpoints in phase I/II insomnia trial

Feb. 20, 2020
By Tamra Sami
PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
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Bionano Genomics sees encouraging results from study of Saphyr

Feb. 19, 2020
By Liz Hollis
The results from a study comparing San Diego-based Bionano Genomics Inc.’s Saphyr to traditional cytogenetic methods for the clinical analysis of leukemia genomes revealed that the system was 100% concordant with the standard of care for the detection of somatic chromosomal abnormalities.
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Newco news

Reinvented Coimmune has a new IND and two clinical trials

Feb. 19, 2020
By Lee Landenberger
It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
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Coronavirus and DNA

Coronavirus waylays China trials, may delay regulatory approvals too

Feb. 18, 2020
By Elise Mak
BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians.
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