Pharmaceutical Technology

NOVEMBER 9, 2022

million price tag. The value calculation behind Roctavian’s suggested price relies on the current expenses that haemophilia A patients face in the US. The post Can gene therapies for haemophilia defend their high price tags? After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8

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Gene Therapy Gene FDA Approval Medicine 278

Rethinking Clinical Trials

NOVEMBER 1, 2022

Participant feedback revealed that shorter more targeted surveys focusing on the most high-value information may have been less burdensome for participants. pctGR, @Collaboratory1.

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Trials Clinical Research Vaccination Vaccine 130

XTalks

MAY 1, 2024

Related: New Snacks of 2024: Discover What’s Coming to the Snack Aisle Walmart’s Legacy of Successful Private Labels Walmart is no stranger to the private label sector, with established brands like Great Value that have consistently delivered quality at low prices.

Branding 52

Branding Production Sales Marketing 52

Rethinking Clinical Trials

JULY 14, 2023

The study found that virtual parenting support coincided with the COVID-19 and helped families deal with the impact of the pandemic; GGC was delivered with high fidelity across cohorts, sessions, and sites; parents were satisfied with virtual GGC, with parents valuing the flexibility, connection and community.

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Clinical Trials Clinical Trials Trials Research 130

pharmaphorum

OCTOBER 3, 2022

Currently, the ALS drug is priced about five times higher than the top of a value-based range. Following news of Relyvrio’s $158,000 annual price tag, both ALS advocates and outside observers have voiced outrage at the cost. The post Amylyx ALS drug draws criticism over $158,000 price tag appeared first on.

Drugs 52

Drugs Generic Drugs FDA Approval Trials 52

Rethinking Clinical Trials

MAY 5, 2023

There is an approach that targets values in the low end of the range commonly seen in critical care (about 88-92% range of SpO2 values), an approach that targets a middle range (92-96% SpO2), or an approach that targets values at the higher end of the range (96-100% SpO2). For many patients, this did not happen.

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Trials Clinical Trials Clinical Trials Development 130

Rethinking Clinical Trials

SEPTEMBER 16, 2022

Academic medical systems place a high value on faculty autonomy, where individual investigators determine the focus of their research. They place a high value on external funding that their faculty bring into the institution. We should all think about how our organizations can move in this direction. Learn more. More info: [link].

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Clinical Trials Clinical Trials Trials Research 100

Rethinking Clinical Trials

FEBRUARY 22, 2023

To what extent were you observing the methods for providing value to the patients through the app actually changing the observed function? They liked being kept up to date about general medicine and this provided value to them. The engagement with the original Apple health study was not good, about 30-40%.

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Clinical Trials Clinical Trials Trials Nurses 130

Rethinking Clinical Trials

JUNE 7, 2023

Since you demonstrated that a couple sites were able to care for subjects in any location, would you say more about the value that the additional separate clinical sites provided? A lot of this has to do with the infrastructure, PROACT tapped into a unique device infrastructure. There were sites that did no remote consent or enrollment.

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Clinical Trials Clinical Trials Trials Cardiology 130

Rethinking Clinical Trials

JULY 13, 2023

Would this provide incremental value? Tags #pctGR, @Collaboratory1 The post Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. Salem Hospital is affiliated with the health care system but is a community-based hospital. What is going on at Mass General?

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Clinical Trials Clinical Trials Scientist Research 130

Rethinking Clinical Trials

JULY 9, 2023

Another crucial element of the health equity–focused model is ensuring that the question at the heart of the research is of value to the clinics and their leadership. For every trial, one of the first important tasks is to reach out to the community health center leadership and see if they are interested.

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Clinical Trials Clinical Trials Trials Research 130

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.

Drugs 147

Drugs Medicine Marketing Development 147

Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. ICER uses quality-adjusted life year (QALY), a cost effectiveness metric to measure the value of a healthcare intervention.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

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.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

XTalks

OCTOBER 28, 2021

No one should have to compromise their values to indulge in a delicious treat.”. According to a report from Grand View Research, the global vegan baking ingredients market size was valued at $1.1 Related: Better Bagel: The Low-Carb, High-Protein Bagel That’s “Changing the Grain”. percent from 2019 to 2025.

Protein 98

Protein Packaging Packaging DNA 98

Rethinking Clinical Trials

AUGUST 30, 2023

. – For an intervention that did not have demonstrable effect but did have qualitative patient value, how do you think about continuing the dashboard verses de-implementing it or do you think over time it will become more useful in more ways? I am still optimistic that we will see some improvements in the outcomes we specified.

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Trials Clinical Research Coordinator Medicine Clinical Trials 143

pharmaphorum

NOVEMBER 16, 2021

. “We look forward to the full technology appraisal guidance (TAG) which is due to be published in early December 2021,” he added. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

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Drugs Medicine Clinical Trials Clinical Trials 94

Rethinking Clinical Trials

AUGUST 11, 2022

At the individual level there is interest and commitment, and we see the value in this but there are barriers that do get in the way. It’s an example of the kind of barriers there are to innovative approaches. How can we chip away at the barriers? Calling them out is step one. Read the full study. pctGR, @Collaboratory1.

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Trials Clinical Trials Clinical Trials Research 130

XTalks

OCTOBER 19, 2023

In August, Campbell Soup acquired Rao’s sauce owner Sovos Brands for $23 per share, reflecting a total value of a staggering $2.7 Despite the premium price tag, the brand has gained a cult following thanks to its inclusion of high quality ingredients and successful word-of-mouth marketing.

Branding 59

Branding Packaging Packaging Production 59

pharmaphorum

JUNE 12, 2022

Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 million price tag, saying its ability to help patients reach sustained transfusion independence justified its high price. In April, influential US cost-effectiveness watchdog ICER endorsed beti-cel’s proposed $2.1

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

The Pharma Data

JANUARY 31, 2021

Ralf Clemens , Chairman of the Scientific Advisory Board for Clover’s COVID-19 Vaccine Program said, “This phase 1 dose-finding and adjuvant justification study demonstrated the potential of Clover’s adjuvanted vaccine candidates to bring added value to the global portfolio of COVID-19 vaccines. About Trimer-Tag© Technology.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Rethinking Clinical Trials

NOVEMBER 9, 2022

The success of the podcast shows the need and value for asynchronous training. CardioNerds started as an educational podcast, which in the first month had 5,000 downloads and now has had more than 3 million downloads in 192 countries. The mission and the people involved with CardioNerds are the key ingredients for its success.

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Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

NOVEMBER 6, 2023

Expressions for ICC are more complicated with multiple membership structures, since the value of each ICC depends on the agent weights for ICCs found for pairs of agents. In multiple membership structures, random effects for agents are weighted, which reflects the proportion of treatment a participant receives from an agent.

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Trials Clinical Trials Clinical Trials Contamination 130

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.

Life Science 105

Life Science Marketing Branding Drugs 105

pharmaphorum

APRIL 14, 2022

million price tag. ICER’s report notes that beti-cel meets its value threshold as a treatment for transfusion-dependent thalassaemia (TDT) “at a cumulative price of $2.1 The gene therapy has already been approved for marketing in the EU and UK, where it was launched at a cost of around $1.7

Gene Therapy 64

Gene Therapy Gene Marketing Clinical Trials 64

XTalks

MAY 2, 2024

Day 1 Highlights Pamela MacDonald from the Canadian Food Inspection Agency (CFIA) kicked off the conference with insights into future trends in food inspections and the value of collaborative efforts with inspectors. Read on to gain valuable insights from top industry leaders and learn more about the exciting innovations in food safety.

Compliance 110

Compliance Regulation Production Containment 110

XTalks

DECEMBER 13, 2023

Related: Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod Casgevy and Lyfgenia Pricing and Warnings The price tags of both gene therapies are steep, given the complexity of developing gene therapies and as therapies meant to be one-time treatments. Vertex-CRISPR’s Casgevy has a US list price of $2.2

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Gene Therapy FDA Approval Gene In-Vivo 98

The Pharma Data

DECEMBER 3, 2020

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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Delveinsight

FEBRUARY 9, 2021

Breyanzi will come with a price tag of USD 410,300 wholesale price, said the company, justifying it after taking into consideration several factors including medical and clinical value, patient value, and societal value. TG Therapeutics Wins FDA Nod for Ukoniq for Marginal Zone Lymphoma and Follicular Lymphoma.

FDA Approval 52

FDA Approval Marketing Research Protein 52

XTalks

JULY 12, 2021

On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug. This despite the drugmaker stating that its pricing principles are based on accessibility and bringing value to patients, and remaining “flexible to enable affordability for patients across economic circumstances.”.

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Drugs Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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Production Pharma Production Pharma Companies Drugs 264

XTalks

NOVEMBER 24, 2022

While the price tag of Hemgenix is quite steep, CSL Behring told Fierce Pharma that the cost of treating patients with moderate to severe hemophilia to healthcare systems is more than $20 million over their lifetimes.

Gene Therapy 52

Gene Therapy Gene FDA Approval Genetics 52

Drug Discovery World

JANUARY 30, 2024

He said: “The industry, as a whole, needs to carefully consider the true value of curing lifelong genetic or degenerative diseases, particularly when evaluating novel therapeutics that present unique treatment opportunities.” Developing value-based payment models that consider long-term benefits could improve access.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

XTalks

SEPTEMBER 27, 2022

The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. The price tag reflects “the clinical benefit [it] provides as an urgently needed treatment option to slow the progression of neurologic dysfunction in children impacted by progressive, irreversible and fatal rare disease,” Obenshain added.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

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.

Protein 52

Protein Scientist Gene Development 52

XTalks

FEBRUARY 27, 2024

Vogt said Iovance set Amtagvi’s price based on its value as the first drug approved in the post-PD-1 melanoma setting, and the company’s analysis of relevant benchmarks. Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.”

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

OCTOBER 12, 2022

For ASL MR perfusion, water molecules in arterial blood from a feeder artery are magnetically tagged and tracked until they reach the region of interest. Then, the signal difference in the region of interest between the tagged images and control images can be computed to obtain cerebral blood flow (CBF) values ( Figure 3 ).

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Clinical Trials Clinical Trials Trials Drugs 93