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.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Drug Discovery World

SEPTEMBER 4, 2023

In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. In this study, researchers discovered how EGCG breaks apart tangles of the protein tau, a ‘hallmark’ of Alzheimer’s disease.

Medicine 59

Medicine Protein Containment Drugs 59

Drug Discovery World

FEBRUARY 12, 2024

Why has there been so little progress in medicine? After all, these failures come on top of decades and decades of research into these diseases. Animal research Unfortunately, most of the research into these diseases has been conducted on animals. Why has it been so unproductive?

Medicine 59

Medicine Genome Genomics Drugs 59

pharmaphorum

JANUARY 18, 2023

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. The idea of ‘genetic superheroes’ and precision medicine is captivating for researchers, but the concept can be abstract and distant for participants. Why should research be any different? with their priorities.

Genetic Disease 95

Genetic Disease Genetics Research Genome 95

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. 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.

Medicine 52

Medicine Scientist Production Regulation 52

WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

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. Learn more Read more in the New England Journal of Medicine. in the direct laryngoscope group.

Trials 141

Trials Clinical Trials Clinical Trials Medicine 141

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. Vaccine manufacturers have previously studied some variant vaccine candidates and are currently conducting clinical trials of Omicron-specific vaccines. Nadine Rouphael, M.D.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

The Pharma Data

JANUARY 17, 2021

The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. . It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. Following successful engraftment of modified HSCs in the bone marrow, these cells start to produce daughter blood cells which contain the IDS gene and enzyme which are distributed throughout the body, including the brain.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

Trials 130

Trials Medicine Clinical Trials Clinical Trials 130

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. I’m not an anti-vaxxer, but….”

Research 52

Research Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

pharmaphorum

JANUARY 27, 2023

Developing medicines – for people living with disease Dr Mullen’s current role involves providing medical monitoring support, as well as safety, pharmacovigilance, scientific, and medical advice across a range of client projects, including advanced therapies and orphan drugs.

Clinical Trials 108

Clinical Trials Clinical Trials Trials Development 108

pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. The impact of burnout on clinical trials Each staff member involved in a clinical trial is essential to its success.

Clinical Trials 109

Clinical Trials Clinical Trials Trials Clinical Research 109

Delveinsight

AUGUST 17, 2021

The efficacy and safety results were produced from a broad research study, multicenter, open-label, randomized phase 3 trial data from the Keynote-581 trial of the first-line therapy indicated to the patients that resulted in an extension of their survival.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

Advarra

MARCH 10, 2023

Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Doctors 98

The Pharma Data

MAY 8, 2021

MYLIGHT is part of a comprehensive biosimilar development program including analytical, preclinical and clinical data. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Disclaimer. About Sandoz.

Clinical Development 52

Clinical Development Medicine Development Containment 52

The Pharma Data

AUGUST 7, 2020

Researchers at the University of Oxford have said that hydroxychloroquine could be beneficial to COVID-19 patients, despite a general lack of evidence for its effectiveness. . The Oxford researchers and the Wellcome supported Mahidol Oxford Tropical Medicine Research Unit (MORU) are leading the COPCOV study.

Research 52

Research Trials Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 3, 2020

Researchers have discovered that an aggressive form of pancreatic cancer ‘hijacks’ the immune system’s response and therefore is more likely to respond to treatment with immunotherapy, raising hopes for new targets in the fight against the disease. Source link.

Research 52

Research Genetic Analysis Gene Scientist 52

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. All study subjects will receive the same Ampligen treatments.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Pharma in Brief

MAY 29, 2023

Background A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. A CSP is intended to partly compensate innovators for time spent on research and on obtaining marketing authorization.

Regulation 59

Regulation Sales Clinical Trials Clinical Trials 59

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.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . This is because they did not have access to essential medicines needed for treatment.

Medicine 52

Medicine Containment Production Development 52

Drug Discovery World

APRIL 13, 2023

I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children. This followed 2021 results from the Phase-IIb trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

Pfizer

AUGUST 3, 2022

We thank the patients, families, investigators and members of the advocacy community who contributed to this research,” said Chris Boshoff, M.D., Under their investigator’s guidance, patients enrolled in the Phase 3 trial will stop study medication and complete any necessary follow-up evaluations. About REALM-DCM. Disclosure Notice.

Development 101

Development Vaccination Vaccine Production 101

XTalks

SEPTEMBER 28, 2023

XTALKS WEBINAR: A Step-by-Step Approach to eSource in Clinical Trials Live and On-Demand: Thursday, October 26, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to adopt an incremental approach to eSource (EHR to EDC integration) across multiple trial scenarios to overcome real and perceived challenges.

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

Clinical Development 40

Clinical Development Medicine Development Production 40

Drug Discovery World

JULY 20, 2023

The Drug Repurposing symposium at WCP 2023 was chaired by Oscar Della Pasqua, Chair Clinical Pharmacology & Therapeutics, University College London, London, UK, and Dr Viviana Giannuzzi, Head of Research Department, Fondazione per la Ricerca, Farmacologica, Gianni Benzi Onlus, Italy.

Drugs 40

Drugs Clinical Trials Clinical Trials Trials 40

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.

Clinical Trials 64

Clinical Trials Clinical Trials Regulation Bacteria 64

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130