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BioWorld - Friday, December 19, 2025
Home » Topics » Clinical

Clinical
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Daiichi Sankyo releases top-line phase III data for FLT3 inhibitor quizartinib

Nov. 23, 2021
By Gina Lee
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
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In the clinic for Nov. 23, 2021

Nov. 23, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Affimed, Akston, Amring, Amzell, Apollomics, Arctic Vision, Beigene, Catapult, Concentric, Daiichi, Day One, Diffusion, Exelixis, Imara, Innovent, Intellia, Lixte, Neoimmunetech, Noxxon, Pfizer, Pulmonem, Puma, Regeneron, Syneurx, Tennor, Zealand.
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Goats in a field

Goats seen as good candidate for animal studies of knee cartilage repair products

Nov. 22, 2021
By Mark McCarty
Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.
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3D heart in chest

Pulse’s quantitative flow ratio reduces risk in percutaneous coronary intervention

Nov. 22, 2021
By Doris Yu
Pulse Medical Imaging Technology Co. Ltd.’s latest trial showed its quantitative flow ratio (QFR) guidance provided a 35% risk reduction in the one-year rate of major adverse cardiac events, compared to standard angiography guidance. QFR, developed by Pulse, could be used to guide the strategy and optimization of percutaneous coronary intervention.
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Glucose monitoring

PK? OK! Provention moving ahead with teplizumab’s phase III

Nov. 22, 2021
By Lee Landenberger
The FDA has removed an obstacle to Provention Bio Inc.’s development of teplizumab in treating type 1 diabetes.
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In the clinic for Nov. 22, 2021

Nov. 22, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 60 Degrees, Arena, Ascendis, Chimerix, Connect, Dermata, Enanta, Immunic, Immutep, Ionis, Jaguar, Kancera, Oncolys, Plus, Rain, Scancell, Todos, UCB, Vaxart.
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Health professional pointing stethoscope at Clinical Trial words, icons

Clinical news slows, but still up 7% over last year

Nov. 19, 2021
By Karen Carey
Efforts to find new treatments for cancer and infectious diseases account for nearly half of the phase I, II and III clinical data recorded in 2021.
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Skin irritation on hands

Connect sees positive readout in phase IIb AD trial, but Dupixent comps a mystery for now

Nov. 19, 2021
By Michael Fitzhugh
A phase IIb trial of Connect Biopharma Holdings Ltd.'s CBP-201 in adults with moderate-to-severe atopic dermatitis (AD) showed all three doses tested reduced eczema severity vs. placebo by a statistically significant percentage at 16 weeks, meeting the trial's primary efficacy endpoint.
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In the clinic for Nov. 19, 2021

Nov. 19, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AL-S, Astrazeneca, Cassava Sciences, Daiichi Sankyo, Gannex, Imstem, Innovation, Kintara, Moderna, Ox2, Polypid, Tempest.
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Cardiovascular.png

Cardialen wins FDA IDE approval for low-energy pulse therapy

Nov. 18, 2021
By Catherine Longworth
The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).
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