Clinical

Kaleido Reports Results of KB295 in Clinical and Preclinical Studies for the Treatment of Mild-to-Moderate Ulcerative Colitis

Shots: The non-IND/CTA study evaluates KB295 in patients with UC. The study evaluates other exploratory assessments including changes in microbiome composition, SCFA levels & biomarkers of inflammation The clinical study met its 1EP i.e., patients achieved a reduction in 3 biomarkers includes a reduction in median FCP levels (69%), patients identified as responders (74%), reduction …

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Health2047’s new company plans to use AI, research access to improve clinical decision making

Called RecoverX, the company will leverage AI to mine evidence-based research, medical charts, patient conversations and test results and provide clinical insights for clinicians in real time.

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has …

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Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Shots: The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy Celltrion has submitted the IND application for the clinical …

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Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Shots: The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer The 1st study involves assessing of sintilimab + bevacizumab biosimilar vs sorafenib as 1L treatment for aHCC while the 2nd study includes assessing of sintilimab + anlotinib as 1L therapy …

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020 Read More »

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission The …

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Thermo Fisher Expands its Direct-to-Patient Service Offerings

Shots: The company has expanded its Direct-to-Patient service offerings for supporting decentralized clinical trials to lessen clinical trial lengths and costs while increasing patient enrollment and participation rates The company’s expanded Direct-to-Patient services build on its global Clinical Site-to-Patient program that launched in early 2020 to ensure that clinical trial patients have uninterrupted access to …

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GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults …

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Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients …

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Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Shots:  The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the …

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PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions     Wokingham, United Kingdom — 30 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Amresh Bangalore as Software Delivery Manager. In his new role, Amresh will be responsible for overseeing and coordinating the people, resources and processes required to deliver new solutions and upgrade existing products, primarily around the …

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Terminology standards bridging gaps between health systems during COVID-19

The clinical manifestations of COVID-19 are varied, and patients are known to have rapidly changing signs and symptoms that must be tracked with laboratory testing. A patient may start his treatment journey with his primary care physician and will include lab centers, diagnostic centers, inpatient, and home quarantine centers.