Rethinking Clinical Trials

FEBRUARY 28, 2024

Solutions include a bi-directional EDC (electronic data capture system), MyChart for research, and active notifications to study personnel based on entered data. Outcomes including patient reported outcomes, functional assessments including via digital technology, healthcare events or mortality may require identify verification.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Clinical Research 141

Rethinking Clinical Trials

JULY 19, 2023

About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. of the patients ended up being prescribed all 3 therapies, and 37.9% of patients were prescribed all 3 therapies across the intervention sites. In the usual care arm sites, 14.5%

Trials 130

Trials Cardiology Medicine Nurses 130

pharmaphorum

APRIL 20, 2021

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried. billion by 2028.

Sales 111

Sales Medicine Drugs Marketing 111

Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . The therapy was also recently approved by the FDA for patients in the US. . A one-time treatment with etranacogene dezaparvovec costs US$3.5

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

Rethinking Clinical Trials

MARCH 28, 2023

                                           Speakers Erin Holve, PhD, MPH, MPP Chief Research Infrastructure Officer, Patient-Centered Outcomes Research Institute (PCORI) Russell Rothman. Patients and caregivers are integrated into all phases of PCORnet®.-enabled enabled research.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Drug Discovery World

MARCH 2, 2023

The study shows that H3K4me3 ensures genes are transcribed and activated at the right time in a controlled manner, like a set of traffic lights regulating the flow of cars on a busy road. But, until now, scientists lacked an understanding of what the chemical tag does, despite many years of research.

Gene Expression 52

Gene Expression Gene DNA RNA 52

XTalks

DECEMBER 13, 2023

Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke. It can also make patients more susceptible to complications like anemia, jaundice, infections and gallstones. Vertex-CRISPR’s Casgevy has a US list price of $2.2

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

Rethinking Clinical Trials

JULY 6, 2023

For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice. DCTs can make things easier for patients and the research more efficient. While similar to the FDA draft guidance, the EMA guidance differs slightly in its emphasis and lack of certain topics.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Virtual connections. Engagement channels. Joanna Carlish.

Regulation 97

Regulation Marketing Sales Branding 97

Roots Analysis

MARCH 1, 2024

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. Such technologies have been shown to have highly secured features.

Packaging 52

Packaging Packaging Production Manufacturing 52

pharmaphorum

MARCH 23, 2022

Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab). in the IV arm.

Antibody 52

Antibody Sales FDA Approval Trials 52

XTalks

OCTOBER 26, 2021

The Phase III trial results show that Givlaari offers sustainable benefit to AIP patients and confirm its favorable safety profile. The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year. This is a huge development for patients.”. AHP affects 1 in 100,000 people in Europe.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Of these patients, seven have been treated at the recommended phase II dose (RP2D) and regimen.

Development 52

Development Drugs Clinical Development Antibody 52

Intouch Solutions

APRIL 11, 2024

Commercial : Improved experience and communication between patients and doctors. In the pharma industry, precision engagement can be used to present patients, healthcare professionals (HCPs), and other stakeholders with relevant information and support at the right time. It uses customer insights to deliver personalized experiences.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. Jeremy Richter, Tag. We’re all trying to find ways to automate. About the interviewees.

Branding 130

Branding Marketing Pharma Companies Life Science 130

pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52

Drug Discovery World

MAY 22, 2023

But are these price tags a barrier to access? Its subsequent success with approval in the US shows us that some drugs will be unavailable to some markets and patients for now. The fact remains that the science behind the drugs is sound, there is direct patient need, and the medical benefits are pertinent. million per dose.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

pharmaphorum

JANUARY 31, 2023

This lack of trust in such a crucial industry can lead to decreased compliance, poor treatment adherence, and negative health outcomes for patients. Additionally, when patients are prescribed medication, they are often unaware of the mechanism of action, potential side effects, interactions, and contraindications.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Vaccination 52

XTalks

FEBRUARY 27, 2024

Since the activity of TILs can be suppressed by tumor cells, TIL therapies are designed to bolster the number of TILs. Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.” percent) patients with a partial response.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

World of DTC Marketing

DECEMBER 13, 2021

OPENING: American cancer patients spent more than $21 billion on their care in 2019. billion and patient time costs of $4.87 As cancer survival rates rise, so do the price tags of life-saving treatments. Some cancer patients may face out-of-pocket costs of nearly $12,000 a year for one drug.

Drugs 55

Drugs FDA Approval Medicine Containment 55

The Pharma Data

MARCH 23, 2022

Unfortunately, in a Phase 3 clinical trial, treatment with remdesivir did not make a difference in mortality for Ebola virus disease patients. This special enzyme, once fused to Ebola virus polymerase, enables the polymerase to add a molecular tag to any other protein it interacts with.

Protein 52

Protein Genome Genomics Research 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

OCTOBER 12, 2022

Currently, MRI-based perfusion imaging is also being applied to measure changes in inflammation in patients with rheumatoid arthritis and osteoarthritis. Representative images collected by DCE-MRI of a patient with adenoid cystic carcinoma that show a decrease in tumor perfusion after exposure to AG-013736, an oral angiogenesis inhibitor.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

XTalks

AUGUST 17, 2020

However, issues of off-target effects and toxicities associated with cytokine release syndrome (the excessive or overproduction of cytokines from activated immune cells) have presented to be challenges for the therapies. By doing so, you maintain selectivity for the disease and the indication, but you also don’t breach patient safety.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Delveinsight

FEBRUARY 25, 2021

Quest runs 2,200 patient service centers and recruits 5,000 mobile phlebotomists who have experience and expertise in offering phlebotomy services for at-home visits. Working with Quest will help them support convenient access to blood collection for patients and healthcare providers.

DNA 52

DNA In-Vivo Genetics Medicine 52

Delveinsight

JULY 22, 2020

Today the tech-based healthcare industry is providing many unique solutions to the patient’s care which are more efficient and effective than the traditional services. IoT relies on the data collected from devices and provides valuable insights that help in providing the best possible healthcare solution to the patient.

Doctors 59

Doctors Doctor Marketing Production 59

pharmaphorum

NOVEMBER 27, 2022

In recent years, the UK pharmaceutical industry has relied heavily on China and India as providers of active pharmaceutical ingredients. Here’s how applying automaton in pharmaceutical labs can help address these. Reducing capacity issues. End-to-end monitoring for maximum security.

Production 105

Production Manufacturing Drugs Marketing 105

pharmaphorum

JUNE 2, 2022

While in 2021, orphan drugs made up over half of all the US FDA’s approvals, with the figures in European being similarly high – 19 out of 54 approved new active substances. By 2026, the report predicts that each of the top 10 selling orphan drugs will earn between $3 billion and $13 billion.

Drugs 52

Drugs Sales Marketing Development 52

XTalks

AUGUST 23, 2021

Dr. Weninger’s fellow panel members echoed that sentiment and sought to address some of the most pressing concerns around trial design, patient safety and data integrity in trials in this post-approval period for aducanumab. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Intouch Solutions

AUGUST 25, 2021

In this POV, we evaluate the potential impact to the email channel and opportunities to continue to deliver ethical, quality email experiences and personalization for pharma customers, including healthcare providers (HCPs) and patients. which means that 96% of iPhone users do not allow apps to track their activity. The result?

Marketing 52

Marketing Regulation Engineer Branding 52

Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

XTalks

SEPTEMBER 27, 2022

It is specifically indicated to slow the progression of neurologic dysfunction in boys four to 17 years of age with early, active CALD. About half of patients who do not receive any treatment die within five years of symptom onset. 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

Rethinking Clinical Trials

APRIL 13, 2023

The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. – Behavioral science tools, such as these EHR-integrated nudges, must be modified to fit within different settings and EHR systems, but they often provide a strong foundation for other contexts.

Medicine 100

Medicine Trials Cardiology Development 100

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.

Gene Therapy 111

Gene Therapy Gene Antibody Marketing 111

XTalks

NOVEMBER 24, 2022

Hemgenix is approved for patients who currently use factor IX prophylaxis therapy or have serious hemorrhage or spontaneous bleeding episodes. The prevalence of Hemophilia B in the population is around one in 40,000 and 15 percent of patients with hemophilia have the B type. Hemophilia B primarily affects men.

Gene Therapy 52

Gene Therapy Gene FDA Approval Genetics 52

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. A new economic reality is challenging profitability .

Clinical Trials 90

Clinical Trials Clinical Trials Development Marketing 90

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52