AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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XTalks

DECEMBER 19, 2024

Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. Finally, psychiatry clinical trials must also address the variability in treatment responses.

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XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Worldwide Clinical Trials

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

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Clinical Trials Clinical Trials Trials Research 237

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 18, 2024

People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants. Unlike reptiles and fish, which usually replace their fangs on a regular basis, it is widely accepted that humans and most other mammals only grow two sets […]

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Clinical Trials Clinical Trials Drugs Trials 243

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.

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Clinical Trials Clinical Trials Drugs Trials 242

Bio Pharma Dive

JULY 1, 2024

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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Clinical Trials Clinical Trials Trials Drugs 333

Bio Pharma Dive

JUNE 21, 2021

The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. This, in turn, could lead to lower drug prices for patients, making medications more […]

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Clinical Trials Clinical Trials Trials Drugs 186

Bio Pharma Dive

NOVEMBER 29, 2022

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

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Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

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FDA Approval Clinical Trials Clinical Trials Drugs 339

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

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Bio Pharma Dive

JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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Drugs Clinical Trials Clinical Trials Trials 309

ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. Pharma is a conservative industry and will rightly approach something as powerful as AI cautiously.

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Clinical Trials Clinical Trials Trials Life Science 69

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Clinical Trials Clinical Trials Drugs Regulation 243

Worldwide Clinical Trials

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

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Bio Pharma Dive

MAY 17, 2023

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

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Bio Pharma Dive

OCTOBER 19, 2022

Acrivon Therapeutics is looking to fund a development approach it claims could improve the prospects of a cancer drug Lilly scrapped after testing it in clinical trials.

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Clinical Trials Clinical Trials Drugs Trials 294

Bio Pharma Dive

NOVEMBER 28, 2022

Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.

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Bio Pharma Dive

MAY 23, 2024

Clinical trial abstracts posted by ASCO Thursday give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus Biosciences.

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Clinical Trials Clinical Trials Drugs Trials 311

Bio Pharma Dive

APRIL 7, 2022

Treatment with Aduhelm would only be covered for patients enrolled in a clinical trial under the policy, which largely follows a draft proposal released in January.

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Clinical Trials Clinical Trials Drugs Trials 335

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 29, 2024

The Union health ministry has issued final notification defining the clinical research organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September […]

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Clinical Trials Clinical Trials Clinical Research Trials 246

Velocity Clinical Research

JANUARY 30, 2025

Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.

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Clinical Trials Clinical Trials Trials Clinical Research 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 17, 2023

American pharmaceutical company Eli Lilly announced last week that it had seen encouraging clinical trial results of its new Alzheimer’s medication. According to the company, their experimental drug, donanemab, was shown in a late-stage trial to slow cognitive decline by 35 percent.

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Bio Pharma Dive

FEBRUARY 28, 2023

The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run.

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Clinical Trials Clinical Trials Drugs Trials 305

Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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Clinical Trials Clinical Trials Trials Genetics 130

Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.

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Clinical Trials Clinical Trials Drugs Trials 195

XTalks

MARCH 14, 2025

Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. mg and semaglutide 2.4

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Bio Pharma Dive

JANUARY 23, 2023

The results are from a small and short clinical trial, however. A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers.

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Clinical Trials Clinical Trials Medicine Drugs 314

Bio Pharma Dive

OCTOBER 31, 2022

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

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Bio Pharma Dive

JANUARY 24, 2023

The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.

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