Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Drug Discovery World

JANUARY 30, 2023

Dominic Elliston , Managing Director of Evoke Galliard and Evoke Incisive Health, shares his take on how effective clinical trial communications is the key to expediting the delivery of new and extraordinary treatments. What’s that got to do with clinical trials? Tell us about yourself, Dominic. Can you give us an example?

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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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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

SEPTEMBER 12, 2022

I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. Never before did we have families around the table asking, ‘Would I volunteer to be in a trial?’ As a result, it is critical to achieve adequate enrolment that sufficiently power your trials. .

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Drug Discovery World

JULY 19, 2023

Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals. “We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial.

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Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. In the U.S.,

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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Drug Discovery World

JANUARY 5, 2024

New UK authorisation policy draws on international drug approvals The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines.

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Drug Discovery World

JUNE 7, 2024

VCGs are an established practice in some clinical trials, however the application to preclinical research is new. Charles River is partnering with internal and external stakeholders, including regulators and leaders from the biopharmaceutical industry to advance this research.

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Drug Discovery World

JULY 30, 2024

Their findings, published in Annals of Internal Medicine , have raised interest about the drug’s potential benefit for tobacco use disorders (TUDs). The authors have called for clinical trials to evaluate semaglutide’s potential as a TUD treatment.

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The Pharma Data

OCTOBER 30, 2020

The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST). Health Measures in Relation to International Traffic 12.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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Drug Discovery World

MARCH 31, 2023

News round-up for 27-31 March by DDW Digital Content Editor Diana Spencer. As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Ongoing clinical trials.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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Drug Discovery World

JUNE 15, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. Regulation is necessary, but optimising timescales would be ideal.

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Drug Discovery World

OCTOBER 24, 2023

MP : I think industry and academia just now are starting to discover the potential that this technology has, as treatments for various diseases that use CRISPR are in clinical trials, but there are so many more applications that could be developed. Treating disease is great, but feeding people could be even greater.

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The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Drug Discovery World

NOVEMBER 14, 2023

A very rare, inherited blood clotting disorder, cTTP is caused by a disease-causing mutation in the ADAMTS13 gene, which is responsible for making an enzyme, also named ADAMTS13, that regulates blood clotting. A deficiency in this enzyme causes blood clots to form in the small blood vessels throughout the body.

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The Pharma Data

SEPTEMBER 14, 2020

After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing.

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Drug Discovery World

JANUARY 11, 2024

Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification. We aim to apply this approach to other inherited liver diseases and translate mRNA therapy to patients, especially in children.”

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

JANUARY 23, 2023

Additionally, the clinical trial period will be considerably shorter than that required for new drug development. As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. What is the regulatory landscape of medical cannabis? There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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Drug Discovery World

OCTOBER 31, 2023

It has been used experimentally in international trials 1 , but researchers are hopeful that further use and evaluation in the UK will accelerate drug development for hard-to-treat neurodegenerative diseases. Currently, 15 trials of the new potential therapies for ALS have included NfL as an endpoint 8.

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DrugBank

APRIL 25, 2024

Overcoming internal resistance to change is also part of the journey, requiring clear demonstration of AI's benefits and involving your team in the transition. This tech can speed up everything from drug design to clinical trials by processing complex datasets more efficiently. In the U.S.,

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. Communication in this area included on-line videos, webinars, summits, conferences, and international outreach.

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