Revolo advances plans to tackle eosinophilic esophagitis with orphan drug tag
Pharmaceutical Technology
JANUARY 31, 2024
The FDA has granted an orphan drug designation to Revolo’s ‘1104, with plans for a Phase IIb study later this year.
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STAT+: Lawmakers tell Pfizer CEO to ‘back off’ on planned price hike for Covid-19 vaccine
STAT News
DECEMBER 13, 2022
lawmakers wrote Pfizer chief executive officer Albert Bourla that he should “back off” from plans to charge Americans up to $130 for the company’s Covid-19 vaccine, a move they described as “pure and deadly greed.” argued the planned price tag is nearly four times the current $30 price paid by the U.S.
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STAT+: Pharmalittle: New York officials press pharmacy chains over abortion pill; Sanders pushes bill for $20 insulin cap
STAT News
MARCH 10, 2023
This is, you may recall, our treasured signal to daydream about weekend plans. On a lighter note, spring is edging closer, so this may be an opportunity to clean out the castle or look further afield and plan a summer getaway. Or you could simply plan the rest of your life. And so, another working week will soon draw to a close.
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Are You Ready for GA4? Enhancements for Measuring Engagement
Intouch Solutions
JUNE 27, 2023
Based on this new metric and way of reporting, it is vital to partner with a tagging solutions expert to successfully tag the site that follows the GA4 event structure model. Events – Event Name and Detail replaces Event Category, Action, and Label.
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Cartherics grants licence for CTH-004 to Shunxi
Pharmaceutical Technology
MAY 1, 2023
CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. In animal models of ovarian cancer, it demonstrated promising results.
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Chocolate Shortage Looms Ahead of Easter 2024
XTalks
MARCH 25, 2024
However, she emphasized, “Our strong marketing plans, innovation and brand investments will drive top-line growth and meet consumers’ evolving needs.” For consumers, the joy of indulging in Easter chocolates may come with a higher price tag, prompting a reflection on the sustainability and future of this beloved treat.
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Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)
Rethinking Clinical Trials
JULY 6, 2023
Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. The European Medicines Agency (EMA) released a separate guidance around DCTs in December 2022.
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Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)
Rethinking Clinical Trials
DECEMBER 20, 2023
. – What about women who are excluded because they are pregnant or planning to be pregnant? Tags #pctGR, @Collaboratory1 The post Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC) appeared first on Rethinking Clinical Trials. It is an excellent question.
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Risk-sharing agreements are growing at a rate of 24%
Pharmaceutical Technology
FEBRUARY 10, 2023
This is not the first treatment to come with a high price tag. Partly in response to such drugs, risk-sharing agreements (RSAs) have increased in popularity and aim to mitigate the risks of including high-cost drugs on reimbursement lists and healthcare plans.
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Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)
Rethinking Clinical Trials
JULY 22, 2022
The normal timeline for public-private partnerships is around 9 months of planning. Associate Vice President, Research Partnerships. Foundation for the NIH. ACTIV, COVID-19, FNIH. Key Points. There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical. . pctGR, @Collaboratory1.
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Grand Rounds October 7, 2022: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)
Rethinking Clinical Trials
OCTOBER 13, 2022
We planned this trial with three centers and then the third center did not get the approval by the ethics committee, so we had to include 12 centers. What I learned from designing this trial is that you can never plan that centers will recruit the same amount of patients as we would do in the initiating center. pctGR, @Collaboratory1.
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Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)
Rethinking Clinical Trials
NOVEMBER 6, 2023
Studies should probably plan how they are desired to be planned. When trials are being planned, we assume there will be some loss to follow up. For example, maybe you would expect to have one agent interact with the participants in a group.
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Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)
Rethinking Clinical Trials
DECEMBER 6, 2023
Tags #pctGR, @Collaboratory1 The post Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. For stepped-wedge trials there may be potential variation in treatment effect and variation in cluster means over time. There are other designs that work better in that instance, such as a parallel design.
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Grand Rounds March 1, 2024: Effect of an Intensive Food-As-Medicine Program on Health and Health Care Use: Evidence from a Randomized Clinical Trial (Joseph Doyle, PhD)
Rethinking Clinical Trials
MARCH 6, 2024
Additional data sources came from EHR data, health plan claims, and program participation data including food visits and education. There were also surveys to assess program education, diet, a self-efficacy questionnaire, and a self-assessed physical and mental health questionnaire at 0, 6, and 12 months.
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Cancer research drugs: Where is the innovation?
Drug Discovery World
OCTOBER 31, 2022
Click’ chemistry used to tag proteins made by cancer cells. Merck (MSD) and Moderna have revealed plans to work together on the development and commercialisation of an investigational personalised cancer vaccine. A team from the University of Geneva (UNIGE) has found a way to overcome chemotherapy resistance in colorectal cancer.
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Novo Nordisk’s Ozempic Shortage Spurs Demand for Eli Lilly’s Diabetes Injection Mounjaro
XTalks
NOVEMBER 3, 2022
Although the company is planning to double capacity through a new manufacturing expansion in North Carolina planned for the end of 2023, company executives are warning of supply challenges. Lilly plans to begin a rolling submission for Mounjaro in the obesity indication in 2022.
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Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)
Rethinking Clinical Trials
SEPTEMBER 28, 2023
Clinics and practices will need Medicaid state plan amendments that provide adequate funding for community health care workers in well child care and support for implementation. Evidence for PARENT, and other clinic-based interventions that utilize community health care workers in a team-based approach to early childhood well child care.
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7 Social Media Tactics to Increase Webinar Registrations
XTalks
FEBRUARY 17, 2023
6) Tagging Speakers and Partners It’s a great idea to tag your speakers and partners when promoting your webinar. With careful planning, data-driven decision making, and creative content, life science marketers can use social media to their advantage and drive more webinar registrations.
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Grand Rounds August 5, 2022: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc)
Rethinking Clinical Trials
AUGUST 11, 2022
In this design, we come up with how we are going to look at the data, how we plan to react to the data, with one or more rounds of internal evaluations or interim reviews where we make the adaptations to the trial design, if the data says we should. You can conduct platform trials using adaptive trial designs or fixed sample trial designs.
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Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)
Rethinking Clinical Trials
FEBRUARY 14, 2024
DCP planned to launch 5 sites in the first year starting with the Boston Healthcare System. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH) appeared first on Rethinking Clinical Trials.
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Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)
Rethinking Clinical Trials
JANUARY 19, 2023
Researchers seeking to enroll people living with dementia need a plan for assessing participants’ capacity to consent to research participation. You need to have a plan in place for assessing capacity and ability to consent. Going through this process helps researchers see where vulnerabilities might arise and how to address them.
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Medicare savings won’t make a dent in healthcare costs
World of DTC Marketing
SEPTEMBER 9, 2021
A study put a price tag on American’s bad eating habits: $50 billion a year in health care costs, attributable to cardiometabolic diseases such as heart disease, stroke, and type 2 diabetes. However, experiences among individual hospitals vary, and about one-quarter of both for-profit and not-for-profit hospitals lost money in 2016.
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Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)
Rethinking Clinical Trials
OCTOBER 2, 2023
Some of the discussion included insurance coverage where PRO monitoring is included with a prescribed treatment plan. -Can you elaborate on the incentives and marketing recommendation from the Underserved Advisory Group? There was discussion about paying patients and patient advocates for the time they spend advocating for PROs.
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Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)
Rethinking Clinical Trials
JULY 9, 2023
Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design.
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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
The correct STF file-tags are used for datasets and corresponding data definition files. The FDA also recommends including a Study Data Standardization Plan (SDSP) at the time of the IND filing, to document how data standards will be applied for a program’s completed and planned studies and updating it periodically. Code 1734.
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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet
The Pharma Data
JANUARY 31, 2021
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. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. CHENGDU, China , Feb.
Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)
Rethinking Clinical Trials
MAY 19, 2023
Vanderbilt has a plan for bridging this gap through care managers. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. At MU and OHSU we are at about 80-90%.
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Potential disease-modifying therapy for Parkinson’s disease
Drug Discovery World
NOVEMBER 28, 2023
Importance of healthy mitochondrial function Dysfunctional mitochondria are usually tagged for removal via mitophagy with a protein ‘flag’ called ubiquitin. Mission is planning to initiate a MTX325 Phase I trial in humans in early 2024.
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Insights from the 18th Annual Canadian Summit on Food Safety in 2024
XTalks
MAY 2, 2024
Thinking really critically about how AI is going to be placed into developing preventive control plans to strategies for managing pathogens is something that we’re keenly watching.” Sustainability in Food Safety JP Perreault, President of X-Ray Reclaim (a division of Plan Automation Inc.), Xtalks speaking with Jud Sinton.
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Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease
XTalks
DECEMBER 13, 2023
Morgan analysts were also hopeful about bluebird’s clearer commercialization plan for Lyfgenia and market readiness from Zynteglo. Vertex-CRISPR and bluebird plan to assess potential long-term safety risks through a 15-year follow-up study after approval. Vertex-CRISPR’s Casgevy has a US list price of $2.2
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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)
Rethinking Clinical Trials
OCTOBER 11, 2023
The group considered the project aims, study design, statistical analysis plan, and power analysis for each center until all aspects were aligned. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M.
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Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia
XTalks
AUGUST 19, 2022
Zynteglo’s hefty price tag of $2.8 Zynteglo’s weighty price tag posed to be an issue in Europe, with bluebird having to pull the drug shortly after it was approved in the EU due to both issues with securing reimbursement payment plans, and manufacturing problems.
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Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)
Rethinking Clinical Trials
DECEMBER 12, 2023
Tags #pctGR, @Collaboratory1 The post Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS) appeared first on Rethinking Clinical Trials.
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Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)
Rethinking Clinical Trials
MARCH 28, 2023
project has very robust approaches to engaging patients across the continuum of the research from the identification of research questions to the planning phase to the implementation phase to the analysis phase and out to the dissemination of results. connects you to thousands of clinicians and researchers who can support your effort.
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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years
Pharmaceutical Technology
JUNE 29, 2022
Most, if not all, of these therapies used the FDA’s Orphan Drug Designation to aid their development plans. For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications.
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bluebird bio to split into oncology and gene therapy specialists
pharmaphorum
JANUARY 11, 2021
US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. million price tag. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8
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60 Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)
Rethinking Clinical Trials
DECEMBER 6, 2022
Enrollment halted before planned sample size of 200 due to COVID-19. There were two exploratory endpoints: change in mean daily step counts from baseline to 6 months and change in metabolomic profiling from baseline to 3 months. The trial enrolled 187 patients, with 35% women, 47% African American, 10% Hispanic, age 59 years.
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130 Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)
Rethinking Clinical Trials
APRIL 27, 2023
Read about the MyTEMP statistical analysis plan. Tags #pctGR, @Collaboratory1 The post Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N.
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Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)
Rethinking Clinical Trials
AUGUST 28, 2023
The study team plans to enroll 1,800 adult patients with a primary complaint of LBP who contacted a participating primary care clinic to make an appointment with a primary care provider. We do have some sub-group analyses plans for the trial, not specific to imaging, but it is something we could consider.
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130 Grand Rounds August 12, 2022: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)
Rethinking Clinical Trials
AUGUST 18, 2022
The recruitment plan needs to include study materials that are tailored and accessible to the research population. The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. Passitonstudy.org/results. New Ideas study.
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130 Revolutionizing Medicine and Public Health: The Emergence of Big Data in Healthcare
Roots Analysis
JANUARY 28, 2024
Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.
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Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W. Semler, MD, MSc)
Rethinking Clinical Trials
MAY 5, 2023
All adults in the medical ICU or in the ED with planned medical ICU admission were eligible and enrolled at the time of the first receipt of invasive mechanical ventilation. Study sites were in the emergency department and medical intensive care unit at Vanderbilt University. For many patients, this did not happen.
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How COVID-19 Changed Food Sampling in Retail and At Home
XTalks
AUGUST 25, 2021
But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. . In May, Costco said in an investors call that it planned to bring back full sampling at most of its roughly 550 locations by the end of June. But not all businesses suffered without traditional sampling.
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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset
Delveinsight
FEBRUARY 23, 2021
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. It has already initiated production planning for potentially hundreds of millions of vaccine doses in 2021.
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