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BioWorld - Sunday, April 19, 2026
Home » Topics » Clinical

Clinical
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Loooong-acting islatravir shines in HIV prevention and treatment studies

July 25, 2019
By Anette Breindl
MEXICO CITY – Merck Sharp & Dohme's MK-8591, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), impressed in both treatment and prevention studies at the 2019 International AIDS Society (IAS) Conference on HIV Science.
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I-Mab's antibody cleared for trials in advanced tumors

July 24, 2019
By Elise Mak
HONG KONG – China has approved the fourth homegrown CD47 antibody to start clinical trials, intensifying the local CD47 race. Chinese biologics developer I-Mab Biopharma (Shanghai) Co. Ltd. said it received the go-ahead for the clinical study of TJC-4, its differentiated fully human CD47 monoclonal antibody for treating advanced malignant tumors.
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O captain, Mycapssa! Bid by Chiasma nails phase III, oral acromegaly prize won

July 24, 2019
By Randy Osborne
Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.
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Study finds startup Paige's cancer pathology algorithms have clinical-grade accuracy

July 23, 2019
By Stacy Lawrence
Deep learning algorithms developed at the Memorial Sloan Kettering Cancer Center (MSK) were able to distinguish prostate, skin and breast cancer with nearly perfect accuracy in a recent clinical trial. The technology has already been licensed exclusively by New York-based startup Paige.AI, which snapped up a $25 million series A early last year to continue to advance it.
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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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