Rethinking Clinical Trials

DECEMBER 20, 2023

Globally cardiovascular disease (CVD) prevalence had decreased between 1990 and 2010, but it has slightly increased since 2010. First, increasing diversity among trial participants must be a top priority in order to address health disparities and allow for optimal diagnosis and management of CVD in all. years for males and 5.5

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pharmaphorum

JANUARY 9, 2023

First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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Gene Therapy Genetics Gene Clinical Trials 119

The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Severity of disease : It is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including Delta. Studies underway.

Vaccination 52

Vaccination Vaccine Genome Genomics 52

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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Rethinking Clinical Trials

OCTOBER 26, 2023

show that a cure is not sufficient to guarantee disease elimination. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. The current trends of Hepatitis C epidemiology in the U.S.

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Clinical Research Clinical Trials Clinical Trials Research 141

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. Joanna Carlish, managing director, financial services, Tag Americas.

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XTalks

JUNE 28, 2023

Options for managing the symptoms of DMD have been limited. In its approval, the FDA said it considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children and the urgent unmet medical need. million price tag of Elevidys, a one-time gene therapy.

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

DECEMBER 23, 2022

But along with strong efficacy come some considerable risks and costs: cytokine release syndrome (CRS), where a patient’s immune system becomes dangerously over-stimulated, and neurotoxicity are potential side effects that need to be managed. Side effects and cost implications. CellCentric, a U.K-based About the author.

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Development Drugs Clinical Development Antibody 52

Intouch Solutions

APRIL 11, 2024

Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. This can make a difference in all cases, but particularly with rare diseases. In this highly regulated Industry, it has become necessary to address and manage issues related to Data Quality: quality and integrity are crucial for compliance.

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Compliance Marketing Drugs Pharma Companies 52

Drug Discovery World

JANUARY 30, 2024

Dr Naldini open new doors for cures for otherwise untreatable genetic diseases with the full impact of his work still untapped”, she said. Joel Eichmann, Co-Founder and Managing Director, Green Elephant Biotech, agrees that prices need to come down significantly for CGT to be widely available.

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Gene Therapy Manufacturing Gene Clinical Trials 71

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. . EMERYVILLE, Calif.

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Vaccination Vaccine Trials Protein 52

XTalks

JUNE 8, 2021

In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease. Prior to Zolgensma, treatments could only help manage symptoms and attempt to improve quality of life. With a price tag of over $2.5 Why is Zolgensma So Expensive?

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Gene Therapy Gene Protein Trials 110

pharmaphorum

JUNE 2, 2022

R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. As covered in a previous article , the importance of R&D to develop treatments for rare diseases is high. of the global population are affected by a rare disease.

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Drugs Sales Marketing Development 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. “We His latest work on the development of biosensors has huge potential to benefit patients with certain metabolic diseases.”.

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Protein Scientist Gene Development 52

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies.

Antibody 52

Antibody In-Vitro Trials Development 52

pharmaphorum

JANUARY 21, 2022

Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade. “It This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”.

Medicine 52

Medicine Marketing Manufacturing Production 52

Delveinsight

FEBRUARY 9, 2021

Deerfield Management has entered into a research agreement with Dana-Farber Cancer Institute to fuel the development of therapeutics and diagnostics for cancer. The move came not long after healthcare investor giant Deerfield Management has forged a partnership to create the Center for Protein Degradation, investing worth USD 80 million.

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FDA Approval Marketing Research Protein 52

pharmaphorum

JANUARY 31, 2023

Given the high price tags placed on many medications, it’s easy to understand why patients often feel that they are being taken advantage of. As pharmaceutical companies embrace digital solutions that engage patients, we expect to see a boom in patients becoming more empowered partners in managing their conditions (Participatory Health).

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Clinical Trials Clinical Trials Trials Vaccination 52

XTalks

OCTOBER 12, 2022

Features of blood perfusion in the brain detected by MRI now have clinical applications in central nervous system (CNS) cancers, neurodegenerative disease, cerebrovascular disease and demyelinating disease. An overview of the ASL MR perfusion technique to obtain cerebral blood flow (CBF) values.

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Clinical Trials Clinical Trials Trials Drugs 93

Delveinsight

JULY 22, 2020

The overall focus of IoT is to prevent disease rather than curing it. One simple example is that with the help of IoT physicians can track the impact of drug uptake on disease progression on a real-time basis. CVD & Heart Related Diseases. This helps in analysis and diagnosis of health conditions like cardiovascular disease.

Doctors 59

Doctors Doctor Marketing Production 59

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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Drugs Marketing FDA Approval Trials 98

XTalks

AUGUST 23, 2021

It’s useful to look to other disease fields to understand the impact of drug approval on future clinical trials. As diagnostic methods for MS improved, patients in earlier stages of the disease with milder symptoms became the primary population enrolled in studies. Knopman, MD, a clinical neurologist at the Mayo Clinic.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

FDA Law Blog

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., Duchenne, Friederichs’s Ataxia, Sickle Cell Disease, Chagas, ALS). Dormer Jeffrey N. Gibbs Paul M.

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Life Science FDA Approval Drugs Development 81

pharmaphorum

NOVEMBER 28, 2022

Innovation thrives in collaboration, not in isolation – and the open sourcing of Substra is a landmark moment in the use of collaborative AI in medical research,” Ibrahim Haddad, general manager of the LF AI & Data Foundation, said in a statement.

Pharma Companies 72

Pharma Companies Life Science Research Development 72

XTalks

APRIL 29, 2022

Obesity is a chronic disease that requires effective treatment options, and Lilly is working relentlessly to support people with obesity and modernize how this disease is approached. Novo introduced a higher-dose version of Saxenda called Wegovy, which won FDA approval in 2021 for chronic weight management.

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Trials Drugs FDA Approval Clinical Trials 98

pharmaphorum

FEBRUARY 16, 2021

In this first draft guidance NICE raised a series of issues with Zynteglo, which bluebird has already agreed to supply at a confidential discount from its hefty price tag, which is around €1.57 The thing that baffled me most was the lack of understanding of this disease upon the people living with it.”. million in Europe.

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Gene Therapy Gene Medicine Development 93

pharmaphorum

FEBRUARY 26, 2021

Some of the most well-known Janssen products include diarrhoea treatment, Immodium (loperamide), antipsychotic Risperdal (risperidone) and Alzheimer’s disease drug, Reminyl (galantamine). During this tenure, J&J entered into the areas of vision care, mechanical wound closure and diabetes management. billion in cash.

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Sales Production Pharma Companies Marketing 126

Drug Discovery World

NOVEMBER 13, 2023

Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET, on: ‘The singular immune response to dengue and machine learning identification of antibodies in high-throughput sequences’.

Protein 59

Protein Antibody Engineer Scientist 59

Intouch Solutions

JULY 27, 2021

We can also expect other health plans and pharmacy benefit managers (PBMs) to make this approach part of their own toolkits if it proves to be successful. The majority of new products coming to market are specialty drugs targeting rare diseases and new breakthrough approaches to cancer treatment – but innovation comes with large price tags.

Drugs 52

Drugs Marketing Vaccination Vaccine 52

pharmaphorum

OCTOBER 4, 2022

However, one of the early challenges that faced the Biobank on being set up was the difficulty in managing the volume of data that would be produced. The biospecimens and associated health data will then be made available to cancer scientists, potentially offering the opportunity to discover new treatments.

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Drug Discovery World

NOVEMBER 9, 2023

This session will conclude with a plenary keynote session, introduced by Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET. Filip Borgions, Ph.D,

Engineer 52

Engineer Antibody Protein In-Vivo 52

Delveinsight

DECEMBER 3, 2020

Janssen buys a new gene therapy aimed at reversing a severe disease, from Hemera Biosciences. The team said that if further studies turn out to be satisfactory, they could develop therapies, which employ the same method for repairing damage in other organs and probably treat age-related diseases in humans too.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. References The Green Journal. Radiotherapy and Oncology.

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DNA Radiology FDA Approval Development 66

XTalks

MARCH 22, 2023

The years that followed have seen a rise in large pharma companies acquiring much smaller biopharmas with a narrow focus on rare disease therapeutic development. The proton-pump inhibitor is designed to reduce stomach acid levels, thereby treating digestive conditions like gastroesophageal reflux disease (GERD).

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Life Science Drugs FDA Approval Vaccination 97

Drug Discovery World

OCTOBER 21, 2022

As we gain deeper understanding of normal biological processes as well as diseases, researchers and clinicians are increasingly seeking to analyse as many cellular parameters as possible to unravel their complexity. Take, for example, its use for CD4 T cell counting to facilitate HIV monitoring. Kenta Yamamoto received his Ph.D.

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Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 15, 2021

Based on research of the Blue Zones and traditional cultures with the lowest rates for obesity and disease in the world, “247 Leangevity Secrets” shows you the simple lifestyle tweaks you can make today to lose weight, keep it off and improve your vitality well into your 100s.

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Production Containment Medicine Vaccination 52

The Pharma Data

MAY 4, 2021

Additionally, Pfizer published this morning on its website the first-quarter 2021 earnings presentation and accompanying prepared remarks from management. Rare Disease. The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% Total Revenue.

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Vaccination Vaccine Production Sales 40