VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. To learn more, visit [link].

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Outsourcing Pharma

MARCH 11, 2024

On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.

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Pharmaceutical Technology

AUGUST 11, 2022

Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US.

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Drug Discovery World

SEPTEMBER 4, 2023

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

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VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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Clinical Trials Clinical Trials Trials Antibody 40

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

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Outsourcing Pharma

NOVEMBER 29, 2023

Professor Deborah Ashby, interim Dean of the Faculty of Medicine, Imperial College, delivered this yearâs Sally Hollis Memorial Lecture.

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Outsourcing Pharma

MAY 13, 2024

PrecisionLife, an innovative precision medicine company, and Metrodora Institute, a leading US multi-specialty healthcare center, have joined forces.

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XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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Outsourcing Pharma

SEPTEMBER 28, 2022

Outsourcing-Pharma caught up with Esther Mahillo, VP of Operational Strategy and Feasibility, Precision for Medicine to talk about advancements in patient enrollment in oncology and rare disease clinical trials.

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XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. I’m interested to learn more about the history of rare disease trials as it relates to the patient voice. And the idea of personalized medicine was starting to take off.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. CRYOPDP’s global teams are acutely aware of the seismic shift in focusing on cell and gene therapy drug development, and we are dedicated to supporting this emerging wave of new cell and gene therapies,” says Rossi.

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Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Rezvilutamide overview Rezvilutamide is an antineoplastic agent.

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Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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pharmaphorum

JUNE 27, 2022

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. Figure 1: Ethnic composition of cancer clinical trial cohorts in the USA.

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Drug Discovery World

JULY 12, 2024

Covid-19 is no longer in the top five most studied indications, replaced by type 2 diabetes, according to Phesi’s mid-year analysis of clinical trials. The analysis of 66,935 clinical trials reveals that the top five most studied diseases are now breast cancer, solid tumours, stroke, prostate cancer and type 2 diabetes.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. All key questions to consider and address before the therapy even leaves the lab.

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XTalks

NOVEMBER 15, 2023

Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP). There are currently no approved medicines to treat PSP.

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Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical will combine their resources and knowledge to develop NurrOn’s ATH-399A and other compounds targeting Nurr1 [nuclear receptor-related 1 protein] to treat neurodegenerative disorders. They will help to progress ATH-399A towards a Phase I trial.

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XTalks

NOVEMBER 14, 2023

Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals. In trial data shared by Novo in August, Wegovy (2.4 The SELECT trial began in 2018 and is Novo’s largest trial to date.

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Scienmag

JUNE 22, 2021

Credit: Insilco June 22, 2021, New York / Hong Kong — Insilico Medicine, a global leader in end-to-end artificial intelligence for target discovery, small molecule chemistry, and clinical development, announced that it has closed a $255 million from biotechnology experts to progress Insilico Medicine’s current therapeutic programs into (..)

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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Drug Discovery World

JULY 12, 2024

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Asklepios BioPharmaceutical’s (AskBio) AB-1005 which is being developed for moderate Parkinson’s disease. AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy.

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XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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pharmaphorum

MARCH 2, 2021

With COVID-19 forcing a shift towards decentralised trials, two digital health firms – Medable and Seqster – have teamed up to offer ways to also incorporate real-world data into remote study designs. . Patients want clinical trials to fit into their real-world experience, not the other way around,” according to Longmire.

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Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. The integration of trial planning and execution data will be a key win for clinical development.

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pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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