Rethinking Clinical Trials

APRIL 27, 2023

The MyTEMP trial is a pragmatic, cluster randomized controlled trial in Ontario, Canada, to determine if adopting a default center-wide policy of personalized cooler dialysate is superior to a standard temperature dialysate of 36.5 Cluster randomized trials of hemodialysis center-wide policies raise complex ethical issues.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

AUGUST 18, 2022

The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. Learn more: Improving Representation in Clinical Trials and Research. Passitonstudy.org/results. New Ideas study.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Insulin 130

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

Rethinking Clinical Trials

OCTOBER 26, 2023

There are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research. PCORnet is engaging with sites to support the ITAP clinical study for de novo clearance of a qualitative POC HCV test-to-treat platform. A manuscript is under development.

Clinical Research 147

Clinical Research Clinical Trials Clinical Trials Research 147

Rethinking Clinical Trials

SEPTEMBER 16, 2022

One challenge is that academic medical institutions traditionally have multiple missions, including research, patient care, and education, and systemically integrating learning into clinical operations is novel addition to the traditional missions. Steven Joffe, MD, MPH) appeared first on Rethinking Clinical Trials. Learn more.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

Drug Discovery World

JANUARY 30, 2024

Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Streamlining trial designs and regulatory pathways can help. Optimising these processes and exploring alternative delivery methods can bring down costs.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

World of DTC Marketing

SEPTEMBER 9, 2021

The drug industry is trying to convince voters that government negotiations with drug companies will lead to less innovation. New technologies are being developed that allow for virtual clinical trials and other cost-lowering development costs. The problem is that voters don’t believe that pitch.

Drugs 222

Drugs Pharmacy Clinical Trials Clinical Trials 222

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Rethinking Clinical Trials

AUGUST 3, 2023

We can innovate and change our norms and institutions to tackle problems. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? Bergstrom, PhD) appeared first on Rethinking Clinical Trials. Learn more Read Misinformation in and about science.

Medicine 130

Medicine Research Vaccination Vaccine 130

pharmaphorum

JUNE 8, 2021

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” — Dr. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

Drugs 98

Drugs Marketing FDA Approval Trials 98

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

Intouch Solutions

APRIL 11, 2024

The pharmaceutical industry is no stranger to innovation. Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

AUGUST 18, 2022

” In clinical trials of the gene therapy, 89% of 41 patients remained free of the need for blood transfusions after a median of 42 months’ follow-up. million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 million, which compares to the $1.7

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Delveinsight

FEBRUARY 23, 2021

Clover Biopharmaceuticals is a clinical-stage biotechnology company based in China. The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

Delveinsight

FEBRUARY 9, 2021

In the pharmaceutical and healthcare domain, where discoveries take ample time, and success rates are unpredictable, translational research helps in ensuring better and innovative discoveries that act as the fuel for revolutionizing breakthroughs in the domain. Ukoniq’s approval was backed by Phase 2 UNITY-NHL Trial (NCT02793583).

FDA Approval 52

FDA Approval Marketing Research Protein 52

Rethinking Clinical Trials

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

XTalks

FEBRUARY 27, 2024

Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial. Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

DECEMBER 2, 2020

As a consequence of Pfizer’s innovation, the price of citric acid tumbled over the succeeding decades, with the value of the chemical falling by 5/6ths in 20 years. Likewise, tanezumab, an anti-osteoarthritic, failed in trials. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

Sales 127

Sales Production Drugs Marketing 127

XTalks

AUGUST 17, 2020

To learn more about innovations in the field, Xtalks spoke to Anish Suri, PhD, president and chief scientific officer of Cue Biopharma about the company’s initiatives in the development of immune-based biological compounds for the treatment of cancers and autoimmune diseases. Promising Clinical Results.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Decentralized and Virtual Clinical Trials. The pandemic necessitated a shift to off-site, remote and virtual clinical trial options.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

JUNE 15, 2021

The pandemic’s disruption galvanised the biopharma industry into unprecedented action, demonstrating what’s possible when the global scientific community collaborates in exceptional ways and public-private partnerships drive innovation to address a common need. A new economic reality is challenging profitability .

Clinical Trials 89

Clinical Trials Clinical Trials Development Marketing 89

Rethinking Clinical Trials

AUGUST 28, 2023

The IMPACt-LBP study design is a pragmatic, multi-site, two-arm cluster-randomized trial with randomization at the primary care provider (PCP) clinic level. It includes 22 family medicine, primary care and general internal medicine clinics affiliated with Duke University, the University of Iowa or Dartmouth-Hitchcock health systems.

Trials 130

Trials Research Medicine Doctors 130

XTalks

AUGUST 19, 2022

XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research. Register for this free webinar to learn why the agile clinical trial model is a great fit for many rare disease categories, how to navigate the regulatory landscape for agile clinical trials in rare diseases, how to design studies and more.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. Wegovy had a price tag of $1,297 a month when it was first launched. percent and 22.5

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. With promising preliminary safety and immunogenicity results from the Phase 1 clinical study, Clover aims to quickly expand its current 2 x 2000L capacity of the Cytiva FlexFactory, which went into service in January 2020.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Rethinking Clinical Trials

AUGUST 11, 2022

Platform Trial, Study Design, Pragmatic Clinical Trials. Adaptive trial design is an overarching terminology for trials that use accumulating data in a formal way. The most common types of adaptive trial design are sequential design and response adaptive randomization. Faculty of Health Sciences. Key Points.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Delveinsight

DECEMBER 3, 2020

It has been speculated that modifications to the epigenome drive cell ageing, especially a process known as DNA methylation, by which methyl groups are tagged onto DNA. A phase 3 trial of Ovid Therapeutics’ OV101 in Angelman syndrome has flunked its primary endpoint. Merck chooses TriNKET cancer immunotherapy program.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

MARCH 22, 2023

However, this consolidation of power hasn’t been isolated to the drug companies themselves; contract research organizations (CROs) have also been coming together to form clinical trial powerhouses over the last decade. In 2015, LabCorp acquired Covance , and Quintiles and IMS Health formed a joint venture in 2016, dubbed IQVIA.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

Rethinking Clinical Trials

OCTOBER 31, 2023

PaxLC brings together many innovations including online screening, digital medical record review, e-consent, home-delivery of medications, local clinical blood draws, home-based biospecimen collection, online diaries and surveys, digital medical record outcomes, and participant-centricity, and return of results.

Trials 230

Trials Medicine Research Clinical Trials 230

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. Clinical and Research Developments. Indicates calculation not meaningful. and South African variants.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

NOVEMBER 30, 2022

“Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5% One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. billion in 2022 alone to expand capacity.

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

“Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5% One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. billion in 2022 alone to expand capacity.

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246