XTalks

SEPTEMBER 30, 2024

Leading these efforts is Karen Ho, PhD, MSc, Vice President of Translational Medicine at Clene Nanomedicine. The Story Behind the Speed of ALS Dr. Ho’s dedication to ALS research is as much about compassion as it is about science. Ho shares her insights into the challenges and advancements in the field of neurodegenerative diseases.

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Research Clinical Trials Clinical Trials Drugs 59

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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Clinical Trials Clinical Trials Medicine Trials 52

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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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.

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Genetic Disease Genetics Research Genome 97

Pharmaceutical Technology

APRIL 14, 2023

R21 contains Matrix-M, a saponin-based adjuvant from Novavax which makes the vaccine more potent and durable by enhancing immune system response. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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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.

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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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Gene Therapy Gene Trials Clinical Trials 78

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. About Avoca Avoca, a WCG company, has been dedicated to improving quality and compliance in the clinical trial execution process.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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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Clinical Trials Clinical Trials Vaccination Vaccine 76

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. How many people participated in a trial?

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Research Clinical Trials Clinical Trials Vaccination 52

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.

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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.

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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. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. 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?

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Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Jansen, Ph.D.,

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

MAY 8, 2021

The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. Disclaimer. About Sandoz.

Clinical Development 52

Clinical Development Medicine Development Containment 52

Pfizer

SEPTEMBER 25, 2022

Pfizer and Sangamo Therapeutics Announce Phase 3 Trial of Investigational Gene Therapy for Hemophilia A Has Re-Opened Recruitment. Medicines, Research. Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates.

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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. cfDNA Isolation Techniques.

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Clinical Trials Clinical Trials Trials FDA Approval 96

Pfizer

AUGUST 3, 2022

Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. Wednesday, August 03, 2022 - 05:00pm. NEW YORK, AUGUST 3, 2022 – Pfizer Inc. About REALM-DCM.

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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.

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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.

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Research Genetic Analysis Gene Scientist 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 Antibody 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

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

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52

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.

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Clinical Trials Clinical Trials Trials Clinical Research 111

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. 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.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Trials Cardiology Containment Development 52

The Pharma Data

NOVEMBER 16, 2020

has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. Alexander, MD, DMD, FICS.

Trials 52

Trials Clinical Trials Clinical Trials Dermatology 52

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.

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Clinical Trials Clinical Trials Trials Doctor 98

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Trials 52

Trials Production Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 22, 2021

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.

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Trials Vaccination Vaccine Radiology 52

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. NEW YORK , Jan. About MindMed.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 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.

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Regulation Sales Drugs Clinical Trials 59

The Pharma Data

APRIL 27, 2023

The positive opinion is supported by data from the pivotal AReSVi-006 ( A dult R espiratory S yncytial V irus) phase III vaccine efficacy trial. In the trial, the vaccine candidate showed 82.6% (96.95% CI, 57.9–94.1, Across multiple trials, the vaccine candidate was generally well tolerated with an acceptable safety profile.

Vaccination 40

Vaccination Vaccine Trials Containment 40

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 111

Clinical Trials Clinical Trials Trials Development 111

Pfizer

SEPTEMBER 27, 2022

Pfizer is focused on increasing treatment options for patients through research and development as well as innovative, technically advanced manufacturing practices. We’re proud to be strengthening our capacity to develop and produce more advanced medicines that can help improve the lives of patients. Medicines, Research.

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