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.

Drugs 246

Drugs FDA Approval Marketing Development 246

Rethinking Clinical Trials

FEBRUARY 14, 2024

It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico. Among study locations were sites in all 50 states including Alaska, Hawaii and Puerto Rico.

Clinical Trials 152

Clinical Trials Clinical Trials Cardiology Trials 152

Pharmaceutical Technology

MAY 2, 2023

All currently approved CAR-Ts are autologous, with the patient’s T-cells being genetically engineered to target antigens expressed by the cancerous cells. Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category. Cost-related unmet needs also scored highly.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

SEPTEMBER 16, 2022

It is incumbent on all of us, and it should be a central part of the goal for all of us to deliver care to patients and families. We should all think about how our organizations can move in this direction. Learn more. More info: [link]. Additional reading: [link]. pctGR, @Collaboratory1.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

World of DTC Marketing

NOVEMBER 3, 2020

Cardiovascular disease deaths in the US have increased by nearly 17% since 2010, and are among the reasons that life expectancy in the U.S. Obesity, lack of exercise, and too much salt are all contributing to a myriad of health issues that are going to drive up healthcare costs. is lower than in other high-income countries.

Pharma Companies 190

Pharma Companies Scientist Medicine Research 190

Drug Discovery World

DECEMBER 20, 2022

The therapy was also recently approved by the FDA for patients in the US. . Thank you to all for the role you have played in helping us reach this regulatory milestone in Europe.” . A one-time treatment with etranacogene dezaparvovec costs US$3.5 World’s most expensive drug.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

Rethinking Clinical Trials

OCTOBER 2, 2023

In almost all cases, the options are not mutually exclusive, and it is advisable to adopt multiple approaches. It collates and synthesizes foundational resources to create a unified, comprehensive resource. For each consideration, the Guide provides a range of options rather than one “right” way. We are pursuing funding.

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Clinical Trials Clinical Trials Research Trials 152

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.

Life Science 105

Life Science Marketing Branding Drugs 105

pharmaphorum

NOVEMBER 16, 2021

Focal onset seizure is a type of epilepsy in which seizures start in one side of the brain, acconting for around 60% of all epilepsy cases. “We look forward to the full technology appraisal guidance (TAG) which is due to be published in early December 2021,” he added.

Drugs 98

Drugs Medicine Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 17, 2020

TikTok itself meanwhile says it has taken steps to make sure its users have access to reliable information about the pandemic, which will be stepped up as immunisation programmes start in the UK, US and elsewhere.

Scientist 97

Scientist Vaccination Vaccine Medicine 97

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. All patients in the ED and ICU were assigned together to an SpO2 target. Discussion Themes -What was the experience doing these repeated crossovers?

Trials 130

Trials Clinical Trials Clinical Trials Development 130

Roots Analysis

MARCH 1, 2024

Such disadvantages of overt security technologies can be overcome using certain covert security features. The examples of unique codes used for such purposes include linear or 2-dimensional barcodes, human- readable combinations of letters / numbers or unique serialized codes that can be written onto an RFID tag or label.

Packaging 52

Packaging Packaging Production Manufacturing 52

Rethinking Clinical Trials

MARCH 28, 2023

Patients and caregivers are integrated into all phases of PCORnet®.-enabled across all therapeutic areas. We have tried to build engagement that helps us work with the CRNs and health systems to engage a broad array of stakeholders for each project we are doing. has 8 clinical research networks across the country.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

JUNE 7, 2023

The drugs were administered open label and all patients were given a low dose of aspirin. The study used remote enrollment, and there was also a centralized outreach to patients with On-X AVR by mail to all U.S. Tracy Wang: It is safe to say that none of us predicted COVID, and it hit pretty soon after we started enrollment.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Cardiology 130

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. All of this for a drug that has shown questionable clinical benefits, critics say.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 25, 2021

Much like all things pre-pandemic, food sampling took a hit throughout most of 2020 and into 2021. But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. . But not all businesses suffered without traditional sampling. Without it, small businesses took a hit.

Branding 98

Branding Marketing Nurses Production 98

XTalks

JULY 16, 2021

There are several factors to consider, and understanding them will help us to answer the ultimate question: will plant-based meat ever be cheaper, or at least on par, with real meat? But yet, the price tag is still higher than real meat. A pound of Beyond Meat’s Beef burgers carries a price tag of $6.25, Vox reported.

Protein 105

Protein Production Manufacturing Branding 105

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. We’re all trying to find ways to automate. Jeremy Richter, Tag. Build on the rapid responses to COVID-19.

Branding 128

Branding Marketing Pharma Companies Life Science 128

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. The European population is meanwhile estimated at several thousand patients, across all stages, according to registry data.

Protein 52

Protein Sales Drugs Trials 52

XTalks

FEBRUARY 14, 2023

The 2023 Farm Bill is the comprehensive package that US Congress uses to set national agriculture, conservation, nutrition and forestry policy. Spending on the nutrition title alone is expected to push the price tag for the next Farm Bill to more than $1 trillion over the next ten years.

Packaging 98

Packaging Packaging Production Marketing 98

XTalks

MAY 2, 2024

The day concluded with insights from the US Food and Drug Administration’s (FDA) Peter Koufopoulos and a panel on innovative training techniques led by Gwynne Sitsker of Embassy Ingredients and Lennie Ouimette of Kawartha Dairy. As someone who loves tech, I’m interested to see where we go from here.”

Compliance 110

Compliance Regulation Production Containment 110

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. I wish that those of us involved had enough bandwidth to get involved with every major initiative that NHLBI launches, but that’s unfortunately not possible.

Clinical Trials 152

Clinical Trials Clinical Trials Trials Research 152

pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. That’s obviously a challenge that’s relevant to all industries. “As Virtual connections.

Regulation 97

Regulation Marketing Sales Branding 97

pharmaphorum

JUNE 2, 2022

In 1983, the US Congress passed the Orphan Drug Act to encourage more pharmaceutical companies to engage in R&D to develop treatments for rare diseases through the offering of financial incentives. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. It is estimated that between 3.5

Drugs 52

Drugs Sales Marketing Development 52

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. The new way is more collaborative and global. But for outcomes and others you can do virtually.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

Rethinking Clinical Trials

SEPTEMBER 21, 2023

The results showed that about 20% of the cart total was spent on fruits and vegetables across all cases. It was also easier because we used a survey research firm, although I will say we are progressively considering and have started recruiting people through alternate methods.

Clinical Trials 130

Clinical Trials Clinical Trials Sales Trials 130

XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Zynteglo’s hefty price tag of $2.8

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

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. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

Production 264

Production Pharma Production Pharma Companies Drugs 264

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Rethinking Clinical Trials

AUGUST 28, 2023

The field will also need to collaborate on implementation and capacity building, develop responsive and accessible training and avoid all-or-nothing approaches on design and technologies. COVID-19 made us think about things differently, because one couldn’t apply rules, one had to apply principles.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

The field will also need to collaborate on implementation and capacity building, develop responsive and accessible training and avoid all-or-nothing approaches on design and technologies. COVID-19 made us think about things differently, because one couldn’t apply rules, one had to apply principles.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 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.” Broad label questioned. billion in 2027.

Drugs 98

Drugs Marketing FDA Approval Trials 98

Camargo

AUGUST 22, 2021

The correct STF file-tags are used for datasets and corresponding data definition files. For all Module 4 and Module 5 sections (except sections 4.3, Our deep expertise with electronic submissions can help ensure that your submissions are compliant with all FDA eCTD specifications – contact us to find out how.

Containment 190

Containment Bioavailability Cosmetics Packaging 190

XTalks

MARCH 22, 2023

Our webinars have become a key vendor-selection tool for decision-makers across the drug development pipeline — from discovery to commercialization — which is why all ten of the top ten contract research organizations (CROs) have worked with Xtalks. Just shy of 400 million doses have been administered in the US alone.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

Rethinking Clinical Trials

AUGUST 28, 2023

There is also a longitudinal cohort of EHR data for all patients at participating PCP clinics to assess utilization and other broad outcomes. Additionally, the study team noted that patients do not all enter the health system the same way, which is an ongoing challenge.

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Trials Research Medicine Doctors 130