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. “As

Vaccination 263

Vaccination Vaccine Clinical Trials Clinical Trials 263

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

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

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

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.

Drugs 111

Drugs Clinical Trials Clinical Trials Genetics 111

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!

Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Research 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.

Drug Trials 59

Drug Trials Trials Drugs Clinical Trials 59

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.

Regulation 162

Regulation Trials Clinical Trials Clinical Trials 162

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

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

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.

DNA 130

DNA FDA Approval Clinical Trials Clinical Trials 130

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.

Drugs 98

Drugs Clinical Trials Clinical Trials Genetics 98

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.

Drugs 52

Drugs Clinical Trials Clinical Trials Gene Therapy 52

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

The Pharma Data

NOVEMBER 12, 2020

The data were released as one of the “10 Highly Anticipated Late-Breaking Clinical Trial Releases” during the VIVA 2020 Virtual Conference. We continue to be encouraged by the high-quality data and impressive results coming from the DETOUR1 Clinical Study,” says Heather Simonsen, President of PQ Bypass.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Cardiology 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%

Trials 52

Trials Dermatology Clinical Trials Clinical Trials 52

Rethinking Clinical Trials

SEPTEMBER 28, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA) appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials Research 278

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

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.

Gene Therapy 52

Gene Therapy Drugs Drug Delivery Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Sales Compliance 52

Drug Discovery World

FEBRUARY 21, 2024

On day seven, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (three of 16) patients in Group 2 and 60% (nine of 15) patients in Group 3. The primary measure of efficacy was a bone scan obtained seven days after initial frostbite.

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Drugs Cardiology FDA Approval Trials 52

The Pharma Data

NOVEMBER 1, 2020

This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year. +44 (0)20 7495 2379. .

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Life Science 52

pharmaphorum

AUGUST 10, 2020

The new module is part of Certara’s Quantitative Systems Pharmacology (QSP) platform, which has been developed in an attempt to reduce attrition in clinical trials, with around 80% of drugs that move into phase 2 failing due to safety or efficacy issues.

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Trials Clinical Trials Clinical Trials Vaccination 104

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Doctors 98

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

FEBRUARY 24, 2022

It gives me great pleasure to announce that we have completed our first human in Phase 0 clinical trial and entered the full Phase I clinical trial with a once-a-day oral dose of our ISM001-055 anti-fibrotic where the target was identified using AI and the molecule was designed using AI, meaning it is AI-discovered and AI-designed.”.

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Trials Drugs Clinical Trials Clinical Trials 40

pharmaphorum

OCTOBER 12, 2022

Regulation of transdermal delivery systems will be another key theme addressed, in combination with clinical trial optimization. Please direct delegate enquiries to: Contact Oliver Kaye , on +44 (0) 20 7827 6017 or email okaye@smi-online.co.uk. The post Transdermal and Microneedle Drug Delivery 2023 appeared first on.

Drug Delivery 40

Drug Delivery Drugs Packaging Packaging 40

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:?? .

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

The Pharma Data

DECEMBER 8, 2020

SE-223 70 Lund or telephone: +46 (0)46-46 286 85 50 no later than February 28, 2021. Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. 46 (0)46 286 85 50. Phone: +46 (0)46 286 85 50. About BioInvent. The company’s validated, proprietary F.I.R.S.T

Antibody 40

Antibody Clinical Trials Clinical Trials Licensing 40

The Pharma Data

NOVEMBER 10, 2020

+44 (0)20 7495 2379. +44 (0)20 7213 0880. + 44 (0)20 3981 4173. For further enquiries: United Kingdom Investors: Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder. . . . .

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

JUNE 28, 2022

Listen to case studies presenting on pre-clinical and clinical research in areas such as oncology and what can be learned for future clinical trials. For sponsorship enquiries contact Luke Teachen on +44 (0) 20 7827 6002 or email: lteachen@smi-online.co.uk. View the agenda and speaker line – up at [link].

RNA 52

RNA Engineer Development Clinical Trials 52

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

The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 9, 2020

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

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Vaccination Vaccine Regulation Clinical Trials 109

The Pharma Data

JANUARY 3, 2021

Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. +44 (0)20 7495 2379. United States: Investors: Dave Gentry, CEO RedChip Companies Inc.

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

pharmaphorum

APRIL 14, 2022

The two-day conference will bring you high-quality insights and industry connections on the latest clinical trial candidates and a platform for exchanging ideas for tackling the biggest challenge: DELIVERY. Additional Contact Info: T: +44 (0)20 7827 6154. Jimmy Weterings, Principal Scientist, AstraZeneca. EARLY-BIRD RATES: ?BOOK

RNA 52

RNA Clinical Trials Clinical Trials Life Science 52