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BioWorld - Sunday, March 29, 2026
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Woman in pain holding hand over heart

CSL’s phase III misses primary endpoint in reducing cardiac events

Feb. 20, 2024
By Tamra Sami
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack.
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Woman in pain holding hand over heart

CSL’s phase III misses primary endpoint in reducing cardiac events

Feb. 12, 2024
By Tamra Sami
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack.
Read More
Art concept for gene therapy research
Neurology/Psychiatric

Encoded Therapeutics’ gene therapy for SCN1A+ Dravet syndrome gets clinical green light in US and Australia

Feb. 6, 2024
Encoded Therapeutics Inc. is advancing its lead gene therapy candidate, ETX-101, for the treatment of SCN1A+ Dravet syndrome into the clinic.
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Sciwind moves to once-weekly dosing after oral GLP-1 delivers strong phase I obesity data

Jan. 30, 2024
By Tamra Sami
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
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Australia takes first steps toward meaningful reforms to health technology process

Jan. 30, 2024
By Tamra Sami
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
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3D illustration of ovarian cancer cells
Newco news

Cleo’s blood-based ovarian cancer test diagnoses deadly cancer earlier

Jan. 25, 2024
By Tamra Sami
Ovarian cancer diagnostics company, Cleo Diagnostics Ltd. has developed a blood-based diagnostic test for ovarian cancer based on the CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease.
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Sciwind moves to once-weekly dosing after oral GLP-1 delivers strong phase I obesity data

Jan. 24, 2024
By Tamra Sami
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
Read More
Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 23, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
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Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 22, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
Read More
Toll like receptor in cell membrane illustration
Newco news

Axelia Oncology takes its TLR2/6 agonist into the clinic to harness the innate immune system

Jan. 16, 2024
By Tamra Sami
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.
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