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

Pharmaceutical Technology

SEPTEMBER 12, 2022

The approval is based on data from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials. These 52-week trials assessed the safety and efficacy of a 6mg once daily dose of Sotyktu versus placebo and Otezla (apremilast) in a total of 1,684 subjects aged 18 years and above.

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FDA Approval Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

JUNE 24, 2022

The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA. This data comprises two Phase III clinical trials: PREVENT-19, which enrolled nearly 30,000 adult subjects in the US and Mexico as well as a UK-based trial with 15,000 adults.

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Vaccination Vaccine Clinical Trials Clinical Trials 263

ECRG Media's Clinical Research Podcast

SEPTEMBER 24, 2018

In this episode we talk about how to handle feeling overwhelmed at work in the clinical trial space. Clinical Research can go from 0-100 real quick and it can be very overwhelming from time to time. Clinical Research can go from 0-100 real quick and it can be very overwhelming from time to time.

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Clinical Trials Clinical Trials Trials Clinical Research 52

ECRG Media's Clinical Research Podcast

SEPTEMBER 24, 2018

In this episode we talk about how to handle feeling overwhelmed at work in the clinical trial space. Clinical Research can go from 0-100 real quick and it can be very overwhelming from time to time. Clinical Research can go from 0-100 real quick and it can be very overwhelming from time to time.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 52 weeks), Investigator’s Global Assessment (IGA)c 0/1 (64.3%

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Trials Dermatology Clinical Trials Clinical Trials 52

Scienmag

JUNE 15, 2022

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease.

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Drug Trials Trials Drugs Clinical Trials 59

STAT News

MARCH 22, 2023

By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.

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Drugs Clinical Trials Clinical Trials Genetics 111

pharmaphorum

AUGUST 10, 2020

The new “biosimulation” tool is designed to make it easier for vaccine candidates across multiple patient populations through the use of virtual patients and trials, providing insights before any real-life studies have to be carried out. The post Certara adds to its COVID-19 toolkit with virtual trials module appeared first on.

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Trials Clinical Trials Clinical Trials Vaccination 105

Rethinking Clinical Trials

SEPTEMBER 28, 2023

The Parent-Focused Redesign for Encounters, Newborns to Toddlers (PARENT) study was a randomized controlled trial of PARENT verses usual care for parents with infants 12 months and younger over a 12-month study period. The first year was spent allowing the clinics to make the project their own, with input from parents and clinicians.

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Trials Clinical Trials Clinical Trials Research 271

Pharmaceutical Technology

JUNE 22, 2022

The latest approval is based on findings from an international, placebo-controlled, randomised, double-blind Phase III clinical trial assessing the efficacy and safety of Voxzogo. Data from the Phase III trial showed that treatment with Voxzogo offered transient declines in blood pressure.

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Regulation Trials Clinical Trials Clinical Trials 162

ECRG Media's Clinical Research Podcast

NOVEMBER 6, 2018

In this episode we talk about the phases of a clinical research study. All the way from Phase 0 to Phase 4 of a clinical research study is in this episode. All the way from Phase 0 to Phase 4 of a clinical research study is in this episode. Enjoy :) Don't forget to Subscribe for new content!

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Clinical Trials Clinical Trials Clinical Research Trials 52

ECRG Media's Clinical Research Podcast

NOVEMBER 6, 2018

In this episode we talk about the phases of a clinical research study. All the way from Phase 0 to Phase 4 of a clinical research study is in this episode. We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

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Clinical Trials Clinical Trials Clinical Research Trials 52

The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). An illustration of a completed Detour Procedure (Graphic: Business Wire).

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Clinical Trials Clinical Trials Trials Cardiology 52

Pharmaceutical Technology

NOVEMBER 3, 2022

The latest approval is backed by 24-week findings from a Phase II clinical trial (Trial 1092) that analysed 25mg Vemlidy versus placebo in 70 paediatric patients who are treatment-naïve and treatment-experienced.

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DNA FDA Approval Clinical Trials Clinical Trials 130

pharmaphorum

FEBRUARY 24, 2022

Hong Kong-based Insilico Medicine has begun a Phase 1 trial of its AI-discovered and AI-designed anti-fibrotic small molecule inhibitor. . The drug entered Phase 0 human trials in late November, an exploratory microdose trial of eight individuals in Australia.

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Trials Drugs Clinical Trials Clinical Trials 40

XTalks

APRIL 17, 2023

A Potential New Treatment for Atopic Dermatitis Biopharma company Almirall recently announced the publication of positive Phase III data from two clinical studies, ADvocate1 and ADvocate2 , that evaluated lebrikizumab as a monotherapy in adult and adolescent patients with atopic dermatitis. percent on placebo, and EASI-75 responses were 58.8

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Dermatology Antibody Clinical Trials Clinical Trials 97

Pharmaceutical Technology

AUGUST 19, 2022

Based on the complete development programme data, including findings from the Phase III ADVOCATE clinical trial that enrolled 331 AAV (GPA/MPA) patients in 20 countries, the NICE recommended the treatment. The controlled, randomised trial assessed oral 30mg twice-a-day doses of Tavneos versus oral prednisolone on a tapering regimen.

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Clinical Trials Clinical Trials Trials Medicine 130

pharmaphorum

NOVEMBER 7, 2022

The conference will explore advancements in ophthalmic treatments and variety of novel drugs, which are showing great clinical trial data. Further key areas will be gene therapy and Artificial Intelligence with developments on the latest drug pipelines and clinical trials. The conference is co-chaired by Mitchell A.

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Drugs Clinical Trials Clinical Trials Gene Therapy 52

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.

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Vaccination Vaccine Trials Clinical Trials 52

STAT News

MARCH 23, 2023

The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.

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Drugs Clinical Trials Clinical Trials Genetics 98

pharmaphorum

AUGUST 5, 2020

Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Benefits of attending: Identifying unmet clinical needs favouring DD technology. For exclusive tailored sponsorship packages contact: Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.uk. or call +44 (0)20 7827 6088.

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Drug Delivery Trials Development Drugs 52

Advarra

MARCH 10, 2023

To add even more complexity to this rare disease, there are different types : Hemoglobin SS Hemoglobin SC Hemoglobin SB+(beta) thalassemia Hemoglobin SB 0 (Beta-zero) thalassemia Currently, the only cure for SCD is accomplished through a bone marrow transplant. It’s not just a lack of specialists in the U.S.

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Clinical Trials Clinical Trials Trials Doctors 98

XTalks

OCTOBER 5, 2022

Relyvrio, formerly known as AMX0035 in the US, showed in clinical trials that it significantly slowed the loss of physical function in those with ALS. XTALKS WEBINAR: How Sponsors are Accelerating Clinical Trials with Automatic EHR Integration. Investigation of Relyvrio in the CENTAUR Clinical Trial.

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FDA Approval Clinical Trials Clinical Trials Trials 98

pharmaphorum

SEPTEMBER 7, 2020

PRISYM ID makes new senior appointment to drive further growth in clinical trials arena. Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America.

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Clinical Trials Clinical Trials Sales Compliance 52

The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. Clinical Data Expected by End of Year. The clinical data from this trial is expected to available by the end of this year. +44 (0)20 7495 2379. .

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Clinical Trials Clinical Trials Antibody Life Science 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

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Vaccination Vaccine Trials Bacteria 52

pharmaphorum

JULY 15, 2022

SAE Media Group’s 5th Annual Ophthalmic Drugs Conference will explore advancements in ophthalmic treatments and variety of novel drugs, which are showing good clinical trial data. Further key areas will be gene therapy and Artificial Intelligence with developments on the latest drug pipelines and clinical trials.

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Gene Therapy Drugs Drug Delivery Clinical Trials 52

Drug Discovery World

FEBRUARY 21, 2024

Iloprost’s efficacy in treating severe frostbite was established in an open-label, controlled trial that randomised 47 adults with severe frostbite. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

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Drugs Cardiology FDA Approval Trials 52

The Pharma Data

MARCH 23, 2021

Data presented at ENDO 2021 demonstrate clinically relevant weight loss, without weight regain, in people treated with semaglutide 2.4 Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinical trial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4

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Trials Hormones Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. andrew@teamdistil.com , +44 (0) 7775 715775. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations. andrew@teamdistil.com +44 (0) 7775 715775?? . For more information:?? .

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Clinical Trials Clinical Trials Compliance Trials 52

The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. +44 (0)20 7495 2379. +44 (0)20 7213 0880. and Europe.

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Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

JANUARY 3, 2021

The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. +44 (0)20 7495 2379.

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Life Science Clinical Trials Clinical Trials Antibody 40

pharmaphorum

DECEMBER 9, 2020

Pfizer and BioNTech are asking for an Emergency Use Authorization of their vaccine based on phase 3 data, which can be converted into a full licence at a later date once further trial information is published. of participants. of participants.

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Vaccination Vaccine Regulation Clinical Trials 111

Camargo

MAY 10, 2021

The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. 8 Yes, 0 No. The meeting was prompted by a publication by Richard Pazdur, M.D., Drug Product. Indication.

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Development Clinical Trials Clinical Trials Trials 185

pharmaphorum

OCTOBER 5, 2020

In his new role, Amresh will be responsible for overseeing and coordinating the people, resources and processes required to deliver new solutions and upgrade existing products, primarily around the PRISYM 360 regulated labeling platform for clinical trials supplies and medical device manufacturers. www.prisymid.com.

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Life Science Clinical Trials Clinical Trials Compliance 52