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BioWorld - Monday, March 8, 2021
Home » Topics » Clinical

Clinical
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CTAD 2019

Worth the wait, Acadia’s Nuplazid looks good in dementia-related psychosis

Dec. 5, 2019
By Brian Orelli
No Comments
SAN DIEGO – Three months ago, Acadia Pharmaceuticals Inc. said Nuplazid (pimavanserin), its serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor, met the primary endpoint during an interim look at the phase III Harmony study in patients with dementia-related psychosis (DRP).
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Boston Sci’s Watchman scores well at 50 months for hemorrhagic stroke

Dec. 5, 2019
By Mark McCarty
No Comments
The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device.
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Man running up rising arrows

Borealis keys to palace: Aurinia’s Aurora phase III bid with voclosporin lights up LN

Dec. 5, 2019
By Randy Osborne
No Comments
In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study. 
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Cancer stem cells

Omeros touts pivotal data on HSCT-TMA candidate, shielding details

Dec. 4, 2019
By Michael Fitzhugh
No Comments
A pivotal trial of Omeros Corp.'s narsoplimab, an investigational therapy for an occasional but serious complication of hematopoietic stem cell transplant (HSCT), found that just one dose was enough to deliver a beneficial effect in more than half the study's high-risk participants, meeting the study's primary endpoint.
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Ardelyx's tenapanor hits pivotal phase III endpoint in phosphate-lowering study

Dec. 3, 2019
By Michael Fitzhugh
No Comments
New top-line results from a phase III study of Ardelyx Inc.'s tenapanor – recently approved in irritable bowel syndrome – confirmed the drug can also help dialysis-dependent chronic kidney disease patients with hyperphosphatemia achieve reduced serum phosphorus levels vs. placebo.
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Holding out for a hero: Protagonist takes a market hit

Dec. 3, 2019
By Lee Landenberger
No Comments
Protagonist Therapeutics Inc. stock (NASDAQ:PTGX) nosedived 47% on Tuesday after the company released preliminary results from its phase II open-label study of PTG-300, an injectable hepcidin mimetic to treat patients with transfusion-dependent beta-thalassemia.  
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Artery and plaque

Study bolsters case for stenting over bypass in long femoropopliteal lesions

Nov. 27, 2019
By Mark McCarty
No Comments
The recent controversy over the use of paclitaxel in the peripheral vasculature has clouded the larger debate over whether bypass is superior to endovascular therapies for the lower limbs. However, a new study suggests that nitinol stents provide a feasible alternative to bypass even for lesions of the femoropopliteal artery that are 30 cm in length.
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High adherence seen with Digimeds in difficult to treat HCV patients

Nov. 27, 2019
By Annette Boyle
No Comments
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
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High adherence seen with Digimeds in difficult to treat HCV patients

Nov. 27, 2019
By Annette Boyle
No Comments
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
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Up arrow breaking through wall

Treble in mind: Chemocentryx’s successful phase III vaults shares nearly threefold

Nov. 26, 2019
By Lee Landenberger
No Comments
Positive phase III data from the Advocate trial by Chemocentryx Inc. and Vifor Fresenius Medical Care Renal Pharma caused Chemocentryx’s stock (NASDAQ:CCXI) to dramatically rise 281% on Tuesday, clearing the way to an NDA filing for the star small-molecule attraction, avacopan, an oral, selective complement 5a receptor inhibitor.
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