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BioWorld - Saturday, March 28, 2026
Home » Topics » Clinical

Clinical
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Not Accordion to plan, try in PD delivers Intec fizzle; phase III dosing too low?

July 23, 2019
By Randy Osborne
Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.
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Bioxcel sees support for pivotal trial in phase Ib agitation study

July 23, 2019
By Michael Fitzhugh
Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021.
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Kidney problems derail Polyphor's murepavadin trial

July 18, 2019
By Cormac Sheridan
DUBLIN – Shares in Polyphor AG dropped as much as 21% Wednesday as the company shut down two phase III trials of its lead drug candidate, murepavadin, a first-in-class intravenous antibiotic in development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
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Bionomics' BNC-210 fails in agitation; hope hangs on PTSD

July 10, 2019
By Tamra Sami
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
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Mixed clinical news for Intra-Cellular is bad news for stock

July 9, 2019
By Lee Landenberger
Positive data from one clinical trial evaluating lumateperone in patients with bipolar disorder wasn't enough to lift Intra-Cellular Therapies Inc.'s stock Monday as another trial's failure with the same drug severely dampened the price of shares, while analysts took the long, more optimistic view.
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Bionomics' BNC-210 fails in agitation, hope hangs on PTSD

July 8, 2019
By Tamra Sami
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
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Sernova takes aim at type 1 diabetes with Cell Pouch for islet implant

July 5, 2019
By Mark McCarty
The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control.
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Academics failing when it comes to reporting EU trial results

July 5, 2019
By Mari Serebrov
Academic sponsors of clinical trials in the EU are the worst offenders when it comes to not posting completed trial results in the EudraCT database.
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Boston Biomedical halts phase III pancreatic cancer trial testing napabucasin

July 3, 2019
By Lee Landenberger
Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer.
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Harbour boosts translational, clinic work via Erasmus pact

July 3, 2019
By Elise Mak
HONG KONG – Shanghai-based biopharma firm Harbour Biomed Therapeutics Ltd. has inked a 10-year pact with Erasmus MC from the University Medical Center Rotterdam to grow its footprint in Europe. Both sides will develop biotherapeutics to treat cancer and immunological diseases.
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