SCIENMAG: Medicine & Health

JUNE 8, 2023

Researchers from Edith Cowan University (ECU) are leading ground-breaking global trials which could save lives by changing how we treat cancer in the near future.

Treatment 90

Treatment Vaccine Trials Research 90

PLOS: DNA Science

MARCH 28, 2024

FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis.

FDA Approval 93

FDA Approval Treatment FDA DNA 93

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

SCIENMAG: Medicine & Health

MARCH 20, 2024

Milan, Italy: Using a combined scanning technique on patients with early-stage breast cancer improved treatment in almost three out of ten cases in a trial presented at the 14th European Breast Cancer Conference today (Thursday). [1]

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Treatment Doctors Trials 68

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Clinical Development Production Clinical Trials Treatment 69

The Pharma Data

JUNE 2, 2023

Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023 Teva Pharmaceuticals, a U.S. NYSE and TASE: TEVA),today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.

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Treatment Clinical Trials Trials Pharmaceuticals 52

Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). How does the DCI mechanism compare to the design of other drugs for cancer treatment?

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Biochemical Assays Treatment Bioinformatics Disease 98

The Pharma Data

MAY 22, 2023

Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. once-monthly dosing) and 2.7

FDA Approval 52

FDA Approval Pharmaceuticals Treatment FDA 52

PPD

OCTOBER 17, 2024

In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market.

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Therapies Clinical Trials Clinical Research Trials 96

Quanticate

APRIL 5, 2024

Clinical trial professionals are well aware of the unique challenges presented by oncology, a therapeutic area dedicated to the prevention, diagnosis, and treatment of cancers. In this article, we delve into key CRF design considerations for oncology clinical trials.

Trials 52

Trials Clinical Trials Treatment 52

Conversations in Drug Development Trends

NOVEMBER 21, 2023

Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. There are so many patients suffering from diseases that have no treatments. We are committed to supporting reimbursement and exploring ways to increase patient access to treatments. “We

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Disease Treatment Clinical Trials Clinical Development 78

PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Diversity in Dermatologic Disease Prevalence, Presentation and Outcomes Skin conditions affect all skin types and all racial and ethnic groups.

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Clinical Trials Trials Clinical Research Disease 59

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. But a new path for bringing treatments to patients is starting to emerge. We all recognize the vast, unmet medical need.

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Drug Development Clinical Trials Drugs Disease 130

Chemical Biology and Drug Design

MAY 11, 2023

Abstract Parkinson's disease is among the most common forms of neurodegenerative illness, with present treatment being primarily symptomatic and frequently coming with substantial adverse effects. The figure depicts the neuroprotective role of crocin in Parkinson's disease.

Disease 100

Disease Research Clinical Trials Treatment 100

SCIENMAG: Medicine & Health

OCTOBER 4, 2023

Type of work: peer-reviewed/clinical trial/people Credit: Eurostat Type of work: peer-reviewed/clinical trial/people A major clinical trial shows that the drug, esketamine, one of the two main forms of ketamine, outperforms one of the standard treatments for treatment-resistant major depression.

Treatment 52

Treatment Clinical Trials Drugs Trials 52

Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

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Clinical Trials Trials Treatment Therapies 52

The Pharma Data

JUNE 6, 2022

(NYSE: PFE) today announced new data from a planned interim analysis of the Phase 2 MagnetisMM-3 registration-enabling trial of elranatamab in people with relapsed/refractory multiple myeloma (RRMM) whose disease is refractory to at least one agent in each of three major classes of medications approved for the disease.

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Trials Treatment Therapies Disease 52

PPD

SEPTEMBER 7, 2023

For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. Though there has been considerable progress in treatment options, 39 million people across the globe are infected with HIV, with an estimated 1.3 million new infections in 2022.

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Clinical Trials Trials Clinical Research Drug Development 52

PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials.

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Clinical Research Clinical Trials Research Trials 98

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. His mother had a presentation of the disease that suggested her immune system was already on the job.

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Research Immune Response Clinical Trials Therapies 137

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Therapies FDA FDA Approval Treatment 119

Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? From a regulatory standpoint, agencies like the U.S. These aspects influence a patient’s perceived health-related quality of life (QoL).

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Clinical Trials Trials FDA Clinical Research 52

Drug Target Review

DECEMBER 23, 2024

While these therapies hold great promise for improving cancer treatment outcomes, their development presents significant challenges, especially in achieving the optimal balance between efficacy and safety. Properly managing these toxicities is crucial to enhancing the safety and therapeutic effectiveness of ADC treatments.

Research 52

Research Treatment Therapies Drug Development 52

Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.

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Therapies Drug Development Disease Clinical Development 104

Broad Institute

AUGUST 19, 2024

A common fatty acid may help restore healthy vaginal bacteria after infection By Ari Navetta August 19, 2024 Breadcrumb Home A common fatty acid may help restore healthy vaginal bacteria after infection Treatments using oleic acid, a naturally occurring oil used in cells, could improve treatment of recurrent bacterial vaginosis infections.

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Hospitals Treatment Medical Schools Science 121

Drug Hunter

APRIL 20, 2023

The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: LP0200 has completed a Ph.

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Small Molecule Clinical Trials Trials Licensing 130

Eye on FDA

JANUARY 22, 2024

This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional content regarding the cancer treatment KISQALI(r) (ribociclib). ” The claim was accompanied by a cited reference describing a clinical trial where QoL was included as a secondary endpoint.

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Clinical Trials FDA Drugs Trials 86

The Pharma Data

MAY 22, 2023

DUPIXENT® (DUPILUMAB) LATE-BREAKING PHASE 3 COPD RESULTS PRESENTED AT ATS AND SIMULTANEOUSLY PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE Regeneron Pharmaceuticals, Inc. The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA.

Trials 52

Trials Disease Clinical Trials Therapies 52

Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.

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Therapies Cell Biology Clinical Trials Trials 118

PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs 1.

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Clinical Trials Trials Drug Development Treatment 52

PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Conversations in Drug Development Trends

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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Clinical Trials Trials Disease Drug Development 52

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

Trials 52

Trials Clinical Trials Therapies Treatment 52

Drug Target Review

JANUARY 12, 2024

How does the integration of Real-World Data (RWD) with genomic biomarker data contribute to a more comprehensive understanding of disease progression and treatment response? Biomarker information is also useful for tracking progression of the disease and treatment response. This can lead to a new treatment being offered to the patient.

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Doctors Clinical Trials Treatment Therapies 111

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