Clinical Trials Data

Enrollment Grows as Clinical Trials Become More Innovative During Pandemic | BioSpace | 10/29/2020

… trials. The majority of study enrollments had been paused or delayed when the pandemic hit. Of the 150+ sponsors and CROs Greenphire surveyed, 71% paused enrollment and 58% delayed new study starts . Considering the clinical trials data base currently shows 136,159 studies open , that is a whole lot of people affected. In a world of mobile connectivity, most clinical trials were stuck in their analog process of the past, requiring frequent …

Is Amgen Stock A Buy With No Recent Updates On Its Dual Approach To Targeting Coronavirus? | 10/20/2020

… Novartis ( NVS ) and in June settled a patent challenge with Alexion Pharmaceuticals ( ALXN ) over its rare-disease drug, Soliris. Now, Amgen can launch a biosimilar in 2025. In August, the company released some positive clinical trials data for its drug Repatha in treating high-risk cardiovascular disease patients. But in early October, it and partner Cytokinetics ( CYTK ) released disappointing results for a final-phase clinical trial for a heart treatment …

DULOXETINE capsule, delayed release [REMEDYREPACK INC.] | National Institutes of Health | 10/15/2020

… When duloxetine and ethanol were administered several hours apart so that peak concentrations of each would coincide, duloxetine did not increase the impairment of mental and motor skills caused by alcohol. In the duloxetine clinical trials data base, three duloxetine-treated patients had liver injury as manifested by ALT and total bilirubin elevations, with evidence of obstruction. Substantial intercurrent ethanol use was present in each of these cases, and this may …

From the ER to the High School Football Field, People Want the Response to Covid-19 To Be Evidence-based, Not Political | 9/18/2020

… Clinical trials say otherwise Fauci’s dismissive comments were somewhat surprising, given that the doctor’s agency, the National Institutes of Health (NIH), currently lists 26 studies involving zinc and 7 studies involving budesonide in its clinical trials data base. Patented in 1973, budesonide was commercialized for asthma in the early 1980s and has been used uncontroversially and worldwide ever since. The World Health Organization (WHO) includes budesonide on its List of Essential …

A Virtual Feast: A Preview of Bio-IT World Conference & Expo 2020 | PRWeb | 9/16/2020

… predictive biomarkers, and identify possible avenues of therapeutic intervention, he argues. Wednesday, October 7 Alexander Sherman, Massachusetts General Hospital, will describe how MGH is pursuing patient centricity to bring such information together and bridge clinical trials data with RWD, such as data from EHRs, DNA sequences, image banks, biobanks, -omics, etc. We are introducing patient-centric approaches with a unique secure patient identification and aligning incentives for all players in …

DCGI gives Nod for Restricted Emergency Use to Itolizumab for moderate to severe COVID-19 patients | 7/12/2020

Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data . M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. This indigenous drug has now been …

DCGI gives nod for restricted emergency use for Itolizumab in COVID-19 treatment | 7/11/2020

Comments  Listen to this Article India’s drug regulator has approved Itolizumab, a medicine used to cure severe plaque psoriasis for “restricted emergency use” to treat COVID-19 patients with moderate to severe acute respiratory distress. The approval was given based on clinical trials data , an official communique said. According to a press release M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with …

DCGI gives nod for ‘restricted emergency use’ of Itolizumab for moderate to severe COVID-19 patients | 7/11/2020

Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted ‘restricted emergency use’ authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data .This indigenous drug has now been repurposed for COVID-19. Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name …

Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients | 7/11/2020

Home COVID19 Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients Last Updated on July 11, 2020 at 2:23 pm New Delhi, July 11: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate …

Drug Regulator Okays Psoriasis Injection For Restricted Emergency Use in Treating COVID-19 Patients | 7/11/2020

The use of the medicine is subject to some conditions including requirement of informed consent of patients, a risk management plan and usage only in hospital setup. Published: July 11, 2020 2:51 PM IST By PTI (Picture Courtesy: IANS) New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe …

DGCI approves Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

DGCI approves Itolizumab drug for restricted emergency use on COVID patients July 11, 2020 New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

DCGI gives nod for restricted emergency use of Itolizumab injection on COVID-19 patients | Tumblr | 7/11/2020

… of Itolizumab injection on moderate to severe COVID-19 patients amid the rising number of cases across India. The DCGI gave approval to the use of this injection on COVID-19 patient based on clinical trials data . Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved… College Football Season Teeters on the Brink The idea of playing college sports this fall has felt iffy all along, like …

DGCI okays Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing the drug. Representational image. New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

DGCI okays Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing the drug. Representational image. New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

DGCI okays Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing the drug. Representational image. New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

Personalizing the Power of Clinical Trial Analysis and Data Visualization | 7/2/2020

TOPICS: Clinical Trials Data Analytics July 2, 2020 CluePoints has launch a new business intelligence platform, BEYOND, designed to encompass more than just early risk detection, this extended visualization solution allows Sponsor and CRO users to explore areas of interest in one integrated business intelligence system. CluePoints is a provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. The new, powerful, analytics tool allows users to confidently …

Real-world characterization of blood glucose control and insulin use in the intensive care unit | 7/1/2020

… strategies. However, patient sub-phenotypes have now been identified by clinical and biomolecular profiles within syndromes such as sepsis and acute respiratory distress syndrome (ARDS) 1 , 2 . When these phenotypes are examined in prior clinical trials data , they exhibit strikingly different prognoses and responses to treatment 1 , 3 , 4 . Unpacking this heterogeneity may inform future trials and the provision of individualised treatment approaches. Hyperglycemia remains a commonly encountered complication in …

iBio to be Added to the Russell 2000® and Russell 3000® Indexes NYSE:IBIO | Globe Newswire | 6/26/2020

… two novel vaccines against SARS-CoV-2. Shortly thereafter, we demonstrated manufacturability of both platforms, signed key partnerships with providers of preclinical testing services and adjuvant technologies, and gained support from industry leaders in clinical trials data management. With preclinical immunization data for our IBIO-200 and IBIO-201 COVID-19 vaccine candidates expected in Q3-2020, we see potential additional value-creating milestones in the near term.” FTSE Russell is …

iBio to be Added to the Russell 2000® and Russell 3000® Indexes | Globe Newswire | 6/26/2020

… two novel vaccines against SARS-CoV-2. Shortly thereafter, we demonstrated manufacturability of both platforms, signed key partnerships with providers of preclinical testing services and adjuvant technologies, and gained support from industry leaders in clinical trials data management. With preclinical immunization data for our IBIO-200 and IBIO-201 COVID-19 vaccine candidates expected in Q3-2020, we see potential additional value-creating milestones in the near term.” FTSE Russell is …

Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again? | STAT | 6/18/2020

… analysis. Specifically, two-thirds of the 118 Covid-19 trials analyzed are currently run by universities and companies that have no record of uploading clinical study results to the European Union Drug Regulating Authorities Clinical Trials Data base, or EudraCT , which trial sponsors are required to do so under EU rules. Of these, 39 trials are being run by sponsors that, in the past, violated requirements to upload results. Of the …

Are We Ready to Adopt a New Approach to Run Clinical Trials? | 6/16/2020

COVID-19 has put a spotlight on how the industry runs clinical trials, with the pandemic forcing “hundreds of clinical trials to grind to a halt” per an NPR analysis of federal clinical trials data . 1 Since many new and existing studies are not actively enrolling subjects, and monitors are unable to conduct onsite monitoring visits, the industry has the opportunity in the upcoming months to design more efficient ways …

Calculating change from baseline in R | 6/11/2020

As a statistical programmer working on clinical trials data I frequently have to calculate change from baseline. In clinical trials baseline is typically defined as the last measurement prior to a clinical trial subject receiving any study drug. Change from baseline is frequently calculated for laboratory measurements, e.g. hemoglobin concentration in blood. SAS is still the standard used to program datasets in the pharmaceutical industry but R is catching up …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | PR Newswire | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | Business Wire | 6/9/2020

Read what people are saying about working here. Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | Business Wire | 6/9/2020

Bristol- Purpose: As part of Biometrics & Data Sciences (BDS), the biostatistician is a member of cross-functional development teams, who contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with study team stakeholders within and outside of BDS. Primary Responsibilities: Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the …