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BioWorld - Wednesday, February 25, 2026
Home » Topics » Clinical

Clinical
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Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 26, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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Landscape in follicular lymphoma changing, but don’t give up on PI3Ks just yet

July 25, 2022
By Randy Osborne
Ipsen SA’s $247 million buyout of Epizyme Inc., and the recent decision by Nordic Nanovector SA to dump its phase IIb program with CD-37-targeted Betalutin (177Lu lilotomab satetraxetan), served to highlight the hot space of relapsed/refractory follicular lymphoma, where bispecifics have been showing particular promise.
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Illustration of mitochondrion inside the cancer cell

Alpheus Medical wins orphan drug and fast track designations to fight deadliest form of brain cancer

July 22, 2022
By David Godkin
The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.
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Tense times: Vistagen phase III in social anxiety disorder misses primary endpoint

July 22, 2022
By Lee Landenberger
Top-line results from Vistagen Therapeutics Inc.’s Palisade-1 phase III study of PH-94B for treating social anxiety disorder showed the therapy fell shy of the primary endpoint. The South San Francisco-based company’s stock (NASDAQ:VTGN) fell dramatically on the results July 22 as shares closed 86% lower at 15 cents each.
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Horizon’s sBLA bolsters Krystexxa but Selecta, others marching forth

July 22, 2022
By Randy Osborne
With enrollment set to finish any day in Selecta Biosciences Inc.’s Dissolve II study testing SEL-212 in chronic refractory gout (CRG), investor appetite runs high in the space, as contenders line up to take on Horizon Therapeutics plc’s Krystexxa (pegloticase), the only product approved for CRG.
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Bladder

Nanostics trial to test Claritydx for bladder cancer

July 21, 2022
By Annette Boyle
Nanostics Inc. launched a new trial of its Claritydx Bladder with support from Alberta Innovates to the tune of C$600,000 (US$465,690). The test uses extracellular vesicle detection technology and artificial intelligence to identify bladder cancer and could provide a valuable alternative to cystoscopy for detection of bladder cancer at earlier stages.
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heart-cardio-data.png

Last gasp for Mesoblast’s rexlemestrocel-L in chronic heart failure?

July 21, 2022
By Tamra Sami
Stem cell therapy company Mesoblast Ltd. said that for patients with chronic heart failure with reduced ejection fraction, treatment with rexlemestrocel-L, its allogeneic product candidate, resulted in greater improvement in a prespecified analysis of left ventricular ejection fraction at 12 months relative to controls in the phase III DREAM-HF trial.
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Notal Vision - Home OCT Patient

Clinical studies support use of Notal Home OCT system for tracking ‘wet’ AMD

July 20, 2022
By David Godkin
Notal Vision Inc. released two clinical reports it said prove the feasibility and efficacy of its patient-operated, home-based optical coherence tomography (OCT) device for monitoring wet age-related macular degeneration (AMD). This comes in the wake of a 2021 report that concluded patient operation of the Notal Vision Home OCT (NVHO) and its machine learning algorithm were generally on par with human experts evaluating retinal fluid and fluid volume in patients with AMD.
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Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 20, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
Read More
Ovarian cancer illustration

VBL’s phase III of ofra-vec misses in ovarian cancer, dragging the stock with it

July 20, 2022
By Lee Landenberger
VBL Therapeutics Inc.’s phase III study of its gene therapy, ofranergene obadenovec, in treating ovarian cancer missed its primary endpoints, prompting the company to discontinue the trial and investors to pull way back. Shares of the Tel Aviv, Israel, and New York-based company’s stock (NASDAQ:VBLT) plunged 79% on July 20 to close at 43 cents per share. The $1.62 per share drop in value made it a penny stock. VBL shares hit their high on Nov. 8, closing at $2.53 each. Top-line data for ofra-vec, also known as VB-111, showed no statistically significant improvement in progression-free survival or overall survival.
Read More
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