Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In addition to granting new drug approvals, the FDA is also the gatekeeper for whether a sponsor can conduct the clinical investigations necessary to gather the data required for drug approval. The IND goes into effect; and .

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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

SEPTEMBER 15, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. This enables regulatory reviewers to evaluate and process clinical trials more effectively. full traceability throughout the research process. increased data quality.

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WCG Clinical

NOVEMBER 20, 2023

Why Was My Research Submission/Protocol Deferred? Research submission/protocols are deferred when the Board is unable to determine that the regulatory criteria for approval are met ( 21 CFR§56.111 and 45 CFR§46.111 ). If FDA determines that the research does not need an IND, FDA will issue a statement to that effect.

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Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. Applications for the Conduct of Clinical Studies: INDs vs CTAs.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Rethinking Clinical Trials

SEPTEMBER 13, 2023

The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. The trial operated under an IRB waiver of informed consent with a patient information sheet. For the RSI trial the FDA regulations had not been updated yet.

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The Pharma Data

JANUARY 17, 2021

. The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan.

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pharmaphorum

JANUARY 27, 2021

In medical research, trust has traditionally been hard-fought for. Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. Stop hiding from the mistakes of the past.

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Research Clinical Trials Clinical Trials Vaccination 52

Drug Discovery World

SEPTEMBER 28, 2023

Though the vaginal and endometrial bacterial profiles vary widely between ethnicities and even individuals, research suggests that select microbiome species are linked to specific disease states in all populations. This article will focus on one such area of great unmet need and promise: women’s health.

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Clinical Trials Clinical Trials Regulation Bacteria 64

Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review.

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Clinical Trials Clinical Trials Regulation Research 52

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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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. Reference: Chung DC, et al.

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pharmaphorum

AUGUST 31, 2021

For the healthcare ecosystem to drive research and care, clarity is needed about the opportunities and challenges of ECAs and their value in bringing therapies to patients faster, say COTA Viraj Narayanan and Karla Feghali from ConvergeHEALTH by Deloitte. Myth 2: Implementing an ECA requires too much money, time and resource.

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Clinical Trials Clinical Trials Life Science Trials 89

pharmaphorum

OCTOBER 6, 2021

Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. Think of an Adverse Events dataset and the variables it contains.

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Clinical Trials Clinical Trials Trials Regulation 52

XTalks

FEBRUARY 4, 2021

Data generated through high-throughput omics approaches paired with clinical patient records can give rise to remarkably robust datasets to inform and guide disease insights and development of targeted therapeutics. Generation of strong research dataset cohorts must begin with high-quality clinical samples.

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pharmaphorum

DECEMBER 13, 2022

BYOD in clinical trials. If researchers leverage these and other wearable devices for BYOD eCOA data collection, it makes the process simpler, smoother, and more cost-effective. Historically, equivalency presented a primary hurdle in the adoption of eCOA BYOD for clinical trials. Statistics show there are 6.5

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Clinical Trials Clinical Trials Compliance Trials 59

XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows).

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Advarra

SEPTEMBER 29, 2022

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

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Regulation Research Genetics Compliance 52

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. He said: “But for this market to become a reality, we need much more research into cannabis products and potential indications.

Medicine 52

Medicine Scientist Production Regulation 52

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Regulatory Considerations for Biologics. BLA process (CBER).

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FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. If FDA wanted to create that impression, it likely succeeded.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. It’s an exciting area,” he told The Guardian.

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Clinical Trials Clinical Trials Trials Drugs 52

XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. Timely intervention is imperative to contain and mitigate potential impact.

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Compliance Clinical Development Development Clinical Trials 52

XTalks

DECEMBER 2, 2022

“As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER).

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The Pharma Data

MARCH 23, 2022

To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase. Now scientists at La Jolla Institute for Immunology (LJI) and Scripps Research have found a promising strategy for stopping Ebola virus polymerase. The problems with Ebola polymerase. Many viruses encode their own polymerase.

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Protein Genome Genomics Research 52

XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

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The Pharma Data

NOVEMBER 10, 2020

This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”. billion by 2025, according to Grand View Research 1. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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Life Science Clinical Trials Clinical Trials Trials 40

Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. The product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.

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The Pharma Data

AUGUST 31, 2020

The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, Planning is underway for the Phase 3 program, which is subject to interim data of the Phase 1/2a trials and approval of regulators. S, is underway in healthy volunteers in the United States and Belgium.

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XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.

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Gene Therapy Gene Protein FDA Approval 98

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

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Packaging Packaging Drugs Containment 52

Drug Discovery World

DECEMBER 6, 2022

1 Vaccine development was conducted at great pace and within a year of the first infection being reported, the first Covid-19 vaccine to report phase III clinical trial data demonstrated unexpectedly high efficacy and cleared regulatory efficacy criteria with ease. Indeed, few randomised trials of NPIs have been undertaken.

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