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.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. ASH Clinical News takes it a step further. CEOs will be compensated for keeping costs low and a score on the organization’s innovation.

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Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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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. Wilkins, MD, MSCI) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

APRIL 27, 2023

MyTEMP was innovative and pragmatic, implemented as part of a learning healthcare system, with covariate constrained randomization, registry-based, and embedded in routine care delivered by more than 2,000 nurses at 84 centers. Dixon, PhD MSc) appeared first on Rethinking Clinical Trials. degrees Celsius.

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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.

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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 Vector production: Viral vectors used in some CGTs are expensive to produce due to complex manufacturing processes and limited yields.

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XTalks

JUNE 28, 2023

It said the clinical studies didn’t provide “unambiguous evidence” that the treatment is “likely beneficial” for the patient pool, which included older children such as those six and seven years of age. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

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The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” About Trimer-Tag© Technology. . CHENGDU, China , Feb.

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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.

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The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). CHENGDU, China.–(

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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.

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The Pharma Data

JANUARY 31, 2021

. The Coalition for Epidemic Preparedness Innovations (CEPI) continues to support Clover’s COVID-19 vaccine candidate and will fund its development through licensure. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

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pharmaphorum

JANUARY 11, 2022

“The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a diagnosis is promising for patients and addresses an unmet need,” said Areej El-Jawahri of Massachusetts General Hospital. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

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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.

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The Pharma Data

MARCH 16, 2022

using SNAP-tag) involves labeling cell proteins with a fluorescent dye, thereby enabling researchers to observe how proteins interact in the living cell and where in the cell they are located. With Spirochrome, he commercialized fluorescent probes for cell biology, while with Covalys, he marketed SNAP-tag and other protein labeling methods.

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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.

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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. Manufacturing : Improved operations, efficiency, and production costs.

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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 bluebird has opted to launch it at a cost of $2.8

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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.

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pharmaphorum

JUNE 2, 2021

million price tag make it is the most expensive treatment ever approved for NHS funding, as it provides “exceptional benefit” to babies with the disease. Spinraza was also rejected by NICE in the first instance, but was eventually recommended for SMA types 1, 2 and 3 after a confidential price discount from Biogen.

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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.

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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. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.

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Pharmaceutical Technology

JANUARY 27, 2023

Sanofi’s eligibility requirements follow a similar model to Pfizer’s previous programs, with refunds being dependent on lack of clinical outcome in patients. With these therapies, there is the possibility of there being no clinical benefit and an emergence of adverse events.

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XTalks

FEBRUARY 27, 2024

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. The FDA introduced its Orphan Drug Act in 1983.

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Rethinking Clinical Trials

FEBRUARY 22, 2023

The Heartline Trial has moved to a new form of information sharing, one that is open source, innovates from without, knowledge flows to and from all via the internet, people can share information, retaining credit for it but sharing it freely. There also is no need for an independent clinical event committee to adjudicate events.

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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 .

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pharmaphorum

NOVEMBER 16, 2022

Of the innovations that have happened recently in pharma drug development, it is cell and gene therapy that have received the most attention. However, with a price tag of €1.58 However, a recently released report from the organisation could blow the price tag of Zolgensma out of the water. How to navigate the new climate.

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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.

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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.

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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.

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The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. . SHANGHAI , Nov.

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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.

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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.

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Drug Discovery World

NOVEMBER 9, 2023

Innovative approaches to the challenges of solid tumours Following a chairperson’s remarks from Kerry Chester, PhD, Professor, Molecular Medicine, University College London, there will be three presentations before the plenary keynote session.

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Rethinking Clinical Trials

AUGUST 11, 2022

Platform Trial, Study Design, Pragmatic Clinical Trials. It’s an example of the kind of barriers there are to innovative approaches. The post Grand Rounds August 5, 2022: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc) appeared first on Rethinking Clinical Trials. Assistant Professor. McMaster University.

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Drug Discovery World

NOVEMBER 13, 2023

Yunying Chen, Vice President, Biologics Innovation & Discovery (BID), WuXi Biologics, on: ‘Targeting TAAs to fight cancers: Choice between TCE and ADC’. Nageatte Ibrahim, MD, Vice President, Oncology & Global Clinical Development, MSD, on: ‘The new age of immunotherapy: From checkpoint inhibitors to vaccines’.

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