Rethinking Clinical Trials

FEBRUARY 28, 2024

Outcomes including patient reported outcomes, functional assessments including via digital technology, healthcare events or mortality may require identify verification. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J.

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Rethinking Clinical Trials

JULY 6, 2023

-What is your response to questions surrounding the issue of adverse event reporting issue ? A lot of questions on this topic have to do with the role of the health care provider as it relates to event reporting.

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Rethinking Clinical Trials

JANUARY 23, 2024

What are appropriate endpoints for imaging RCTs and what events are we trying to avoid? Tags #pctGR, @Collaboratory1 The post Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Coronary CT angiography (CTA) may be the preferred test. Angina may not effectively discriminate between strategies. They are pretty good.

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Rethinking Clinical Trials

FEBRUARY 22, 2023

There also is no need for an independent clinical event committee to adjudicate events. In the new model we are using ICD-10 codes, not specific to the trial, to find events and lead to lower specificity, more events. The family can be notified if the patient goes into Afib. Consent is one that should be done virtually.

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Rethinking Clinical Trials

MAY 19, 2023

The data visualization started with a basic list of information needed, including systolic and diastolic data; clinic and home data; raw data numbers, effect of medications on blood pressure; goal ranges; out of range values; customizable goal ranges; patient burden of entry; data variability relative to control, and contextual life event data.

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Rethinking Clinical Trials

MARCH 21, 2023

Learn more Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Discussion Themes – How have clinician views changed in terms of patient-reported symptoms verses clinician understanding of symptoms? You will want a dedicated tool for adverse events.

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Clinical Trials Clinical Trials Trials Research 130

Drug Discovery World

AUGUST 15, 2022

The event will take place on 4-5 Oct, London Excel, UK and topics will include: . Kanza also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data. Click here to register.

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Drugs Research 52

Rethinking Clinical Trials

MAY 25, 2023

Secondary safety outcomes were bleeding events, wound complications, and surgical site infections. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD) appeared first on Rethinking Clinical Trials.

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XTalks

DECEMBER 13, 2023

The sickled red blood cells obstruct flow in blood vessels, limiting oxygen delivery to tissues in the body, which leads to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events, or crises, can lead to life-threatening disabilities and/or early death.

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Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

MAY 2, 2024

The event spanned two days packed with keynote speeches, panel discussions and networking opportunities aimed at enhancing food safety practices across the country. During the event, Xtalks interviewed several sponsors as well as the event’s Chair, Glenford Jameson.

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Pharmaceutical Technology

JULY 14, 2022

Due to the high price tags associated with these speciality medicines, innovators have naturally favoured big markets with high GDP such as the US and EU-5 (Germany, France, Spain, Italy, and the UK). “The Go-to-market strategies. The choice of where to launch an orphan drug is an important and difficult decision.

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Intouch Solutions

JULY 27, 2021

Americans exist in a state of healthcare disparity, and four recent events illustrate just how volatile and pressured the healthcare system is right now. The first recent event was covered in our May article “ $ To Switch ,” where we explained how Cigna was offering patients $500 incentives to switch medications. What’s happening?

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The Pharma Data

JANUARY 31, 2021

No serious adverse events related to the vaccine candidates studied were reported. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. The candidate vaccines were given in two doses, three weeks apart.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

JUNE 29, 2022

This year has already been eventful when it comes to the development of therapies for rare diseases. 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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Rethinking Clinical Trials

NOVEMBER 9, 2022

Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays. If a patient is approached by a fellow, the perspective of the fellow is to prioritize patient care, so there is a built-in level of trust that may come with that and is something we want to explore more. pctGR, @Collaboratory1.

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Rethinking Clinical Trials

APRIL 27, 2023

There is a high risk of these events in the hemodialysis population with a cumulative instance at 30% at 4 years. The mean temperature for the standard group was 36.4 degrees C, and the mean temperature for cooler group was 35.8 The primary composite outcome was cardiovascular mortality or hospital admission with MI, stroke, or heart failure.

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The Pharma Data

DECEMBER 3, 2020

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag © Technology.

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pharmaphorum

DECEMBER 12, 2022

Adverse events such as bruising, headaches, and blood in urine occurred at roughly the same frequency in both groups of patients in ADVANCE IV, and while serious side effects were seen in 8% of the Vyvgart group, that was lower than the 16% reported with placebo.

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Sales Trials Drugs Antibody 52

Rethinking Clinical Trials

FEBRUARY 9, 2023

More analysis is needed to confirm that hypothesis Tags #pctGR, @Collaboratory1 The post Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Thirty-day mortality was higher in the intervention hospital group.

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Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

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Sales Doctors Doctor Gene Therapy 121

XTalks

FEBRUARY 8, 2024

Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla. However, that could be changing.

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XTalks

JUNE 28, 2023

The therapy’s strong clinical safety data helped Sarepta secure the approval, as among 85 patients, only 13 serious side effects and no deaths or discontinuations due to adverse events were reported. million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

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FDA Law Blog

JULY 20, 2021

We previously reported on events that resulted in this rule. The new rule applies not only to product labeling, but to any “mail order catalog” or “mail order promotional material” that includes a seal, mark, tag, or stamp that labels a product as having been made in the United States. The final rule was published on July 14, 2021.

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The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

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Vaccination Vaccine Trials Protein 52

pharmaphorum

JANUARY 21, 2022

The Oslo Medicines Initiative (OMI), which held its first public webinar event last week, was conceived before the pandemic, but it has gained new relevance as it seeks to address this disparity in Europe, a union of countries with hugely varying income levels.

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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. . Instead of pop-up events like in-store booths, it distributed many of the more than one million bags to consumers who ordered online or picked up grocery orders in-store.

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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. If I had to pick one [event], I think that would be the one that we can really celebrate as scientists and as patient advocates.

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XTalks

APRIL 29, 2022

The most common adverse events were gastrointestinal side effects such as nausea, vomiting and diarrhea, which are known complications of GLP-1 drugs, including tirzepatide. Wegovy had a price tag of $1,297 a month when it was first launched. percent reductions of those that took placebo.

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pharmaphorum

AUGUST 18, 2022

million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 They should also be monitored for low platelet counts and bleeding episodes, as these are some of the common adverse events seen with Zynteglo therapy. bluebird has opted to launch it at a cost of $2.8

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Gene Therapy FDA Approval Gene Clinical Trials 52

XTalks

FEBRUARY 14, 2022

The kits include skewers, festive wax paper, a burlap wrap and an original Maine Lobster Valentine tag. But as the Omicron surge continues, White Castle announced last month that it won’t be running the event at all this year. Meanwhile, Lucky Catch Lobster is selling its bouquet kits starting at $89. White Castle.

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Packaging Packaging Branding Marketing 98

pharmaphorum

AUGUST 28, 2020

There’s an opportunity to tap into these non-traditional sources to get early insights on a disease event”. If you start tapping into that data, you not only get insights for individuals, but if you start aggregating it at scale, you get some amazing insights about population-level events.”. Global data mining.

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Medicine Research 67

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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Big Data Medicine Marketing Clinical Trials 40

pharmaphorum

NOVEMBER 27, 2022

This increase in complexity has left the industry wide open to supply chain shocks from events such as the pandemic, regional conflict, trade disputes, and cyber-attacks. For some products, this results in supply chains that are so complex that they start in Asia and circumnavigate the globe twice, before reaching the final destination.

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Production Manufacturing Drugs Marketing 105

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

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Life Science Drugs FDA Approval Vaccination 97

XTalks

APRIL 6, 2021

Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. The pandemic helped them focus on what needs to change to build a sustainably resilient food supply chain — something we may need sooner than later as climate change intensifies extreme weather events, such as droughts and floods.

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Drug Discovery World

OCTOBER 3, 2022

She also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data, which she has continued as part of the Physical Sciences Data Infrastructure (PSDI) Project.

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Drugs Scientist Bioinformatics Medicine 52