Category: Clinical

  • The 3rd Annual RNAi – Based Therapeutics Summit Returns!

    Welcome to the 3rd Annual RNAi – Based Therapeutics Summit: Overcoming Barriers for Targeted siRNA Therapeutics Built with biopharmaceutical industry insights, this in person conference will bring together key opinion leaders to delve deep into the key remaining challenges associated with targeted delivery, translation, CMC and clinical development of targeted siRNA therapeutics for modular, reproducible and effective gene silencing […]

  • Next Generation Kinase Inhibitors Summit

    Turbocharge the Development of the Best-In-Class Kinase Inhibitor Products, to Enhance Specificity, Overcome Resistance to Deliver Safe & Durable Clinical Responses Celebrating 20 years of FDA approval and high efficacy profiles, kinase inhibitors have changed the face of oncology treatment. However, increasing resistance and safety issues limit the success of existing kinase inhibitor classes. The […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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.