PPD

JUNE 7, 2023

The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

Drug Target Review

DECEMBER 13, 2024

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. These can include anti-tubulin compounds, potentially reducing side effects and improving quality of life.

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Therapies Treatment Clinical Trials Drugs 98

Codon

NOVEMBER 3, 2024

The experience showed me that new therapies are needed not only to meet the targets laid out by the End TB Strategy but also to prevent drug resistance from negating the effectiveness of current therapeutics. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent.

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Vaccine Trials Therapies Clinical Trials 92

PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

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Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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Trials Clinical Trials Compliance Treatment 81

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Bioethics 52

PPD

FEBRUARY 10, 2025

By harnessing the full range of innovative technologies and taking advantage of an FSP partners extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget even in the face of complicated global regulations and widely fluctuating workloads.

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Clinical Trials Trials Clinical Research Research 52

Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. Organoids will play increasingly crucial roles not only in research and diagnostics, but also in therapies to restore and enhance the human body.

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Treatment Disease Clinical Trials Molecular Biology 105

SCIENMAG: Medicine & Health

JUNE 15, 2023

A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options. Credit: Vanderbilt University Medical Center A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.

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Treatment Clinical Trials Therapies International 83

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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Trials Clinical Trials International Regulations 59

Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

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International Laboratories Drugs Pharmacokinetics 52

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% between 2020-2027.

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Therapies Research Clinical Trials Trials 52

Drug Patent Watch

DECEMBER 9, 2024

This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents.

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Drugs Drug Development Pharmaceuticals Production 97

The Pharma Data

DECEMBER 11, 2020

11, 2020 — Results from a long-term study of a gene therapy technique to prevent inherited mitochondrial disease show promise, researchers say. But they added a key caveat: The study found varying levels of mtDNA from the mother that replicated and built up within some internal organs. FRIDAY, Dec. in the small intestine.

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The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.

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International Disease Clinical Trials Trials 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. cell and gene therapies), with other therapeutic areas then pushing it further. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

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Trials Clinical Trials FDA Approval Therapies 52

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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Clinical Trials Trials Clinical Research Research 52

Drug Target Review

SEPTEMBER 6, 2024

What trends are driving the increased use of in vivo delivery methods in gene therapy? Finally, the market demand has increased as clinical trials are advancing towards more advanced phases and more vectors are being approved for commercial use. How are new therapeutic areas emerging as potential targets for in vivo gene therapy?

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Therapies Vaccine Marketing Disease 59

PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Clinical Development Clinical Trials Therapies Trials 98

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

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Clinical Trials Trials Clinical Development Clinical Research 52

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Additional trials (e.g.,

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Small Molecule Trials Therapies Disease 138

The Pharma Data

SEPTEMBER 6, 2021

The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. Currently, no treatment is approved for the therapy of RCC, and the medical need for new effective treatments is high. “The As a result, eliapixant may have the potential for safe and effective long-term use.

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Trials Clinical Trials Treatment International 52

The Pharma Data

AUGUST 30, 2021

.–(BUSINESS WIRE)– Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY ® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache Federation Joint Congress 2021. Teva Pharmaceuticals USA, Inc.,

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International Clinical Trials Treatment Trials 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection. Zhao et al.

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Clinical Research Therapies Research Vaccine 52

The Pharma Data

JANUARY 17, 2021

The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia. About Propanc Biopharma, Inc. Propanc Biopharma, Inc.

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Therapies Clinical Trials Trials Hospitals 52

The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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Trials Therapies Clinical Trials Disease 52

The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. With sites in the U.S.,

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Clinical Supply Therapies Clinical Trials Packaging 52

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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FDA Approval Therapies FDA Treatment 52

The Pharma Data

SEPTEMBER 9, 2021

This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy. 8-12, 2021. Please click here for full U.S.

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International Treatment Clinical Trials Trials 52

Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union. Molecular Therapy 20 , 1831-1832 (2012). Russell S, et al. Wang D, Tai PW, Gao G.

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Engineering Virus Therapies Immune Response 105

Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 4, 5 More recently, new combination regimens have emerged that incorporate targeted therapies to treat a variety of blood cancers, including multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and acute myelogenous leukaemia (AML).

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Small Molecule Therapies Treatment Disease 111

The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Hospitals Trials International Clinical Trials 52

Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Clinical Trials Trials Laboratories Research Laboratories 52

The Pharma Data

JANUARY 9, 2021

(NASDAQ: BMRN) today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. This is the largest global Phase 3 study to date for any gene therapy in any indication, with 134 participants.

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Therapies Trials Clinical Trials Treatment 52