Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. He is a researcher at University of Oldenburg, Germany. Frontiers in Medicine.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 3D rendering of Antibody Drug Conjugate Molecules.

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November. billion euros.

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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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The Pharma Data

SEPTEMBER 2, 2021

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. The results of the study enabled Pfizer to proceed to Phase 3.

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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. FDA also directed manufacturers to produce detailed marketing plans.

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LifeSciVC

JANUARY 16, 2024

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinical trials in these areas (below).

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Drug Target Review

OCTOBER 5, 2023

This study sought to shed light on the safety and effectiveness of aHSCT in routine healthcare settings, moving beyond the confines of clinical trials. The research team identified 231 individuals diagnosed with relapsing-remitting MS, with 174 of them having undergone aHSCT treatment before the year 2020.

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The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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The Pharma Data

OCTOBER 25, 2021

First immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting. 4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.

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The Pharma Data

FEBRUARY 21, 2022

All patients in the trial received a HER2 test, and the results were centrally confirmed. The trial met the key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer regardless of HR status (HR-positive or HR-negative). For more information about the trial, visit ClinicalTrials.gov.

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The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

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Drug Target Review

JULY 6, 2023

million scientific procedures involving live animals were carried out in 2020. 1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5%

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The Pharma Data

APRIL 8, 2022

NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.

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New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). This trial involves 93 sites in the U.S.

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Broad Institute

OCTOBER 4, 2023

A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy. AbbVie and Calico are currently testing the molecule and another related molecule , also developed by AbbVie and Calico, in phase 1 clinical trials. We were really impressed by that.”

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DrugBank

JULY 20, 2023

We are excited to bring FDA Orphan data into DrugBank because we know that at the earliest stages of drug discovery, curating reliable scientific data, identifying relevant previous trials, and designing protocols for success are all important, challenging, and time-consuming tasks. of trials stopped due to recruitment issues.

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Drug Target Review

FEBRUARY 2, 2024

Also, adoption of 3D human tissue models will help reduce the number of failed clinical trials because ineffective drugs are weeded out pre-clinically. Lastly, by using 3D human tissue models, patients in clinical trials will be exposed to fewer ineffective drugs, reducing their risk of side effects without any benefit.

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The Pharma Data

NOVEMBER 8, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ In financial 2020, the Group employed around people and had deals of41.4 The Bayer brand stands for trust, trustability and quality throughout the world.

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The Pharma Data

JULY 8, 2021

When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. ” The EMPEROR-Preserved trial investigated Jardiance 10 mg compared with placebo. vice president, Product Development, Lilly.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. MDCG 2020-10 provides guidance on safety reporting during clinical investigations.

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Vial

APRIL 10, 2024

With over 1,100 CROs worldwide as of 2020, choosing the appropriate partner often requires evaluating the advantages and disadvantages of large global CROs versus mid/small ones. Still in its early stages, Vial was established in 2020 and has quickly emerged as a leading CRO. Vial stands out from IQVIA in several key aspects.

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Drug Target Review

SEPTEMBER 21, 2023

Debrah, AY et al (2015) ‘Doxycycline Leads to Sterility and Enhanced Killing of Female Onchocerca volvulus Worms in an Area with Persistent Microfilaridermia after Repeated Ivermectin Treatment: A Randomized, Placebo-Controlled, Double-Blind Trial’, Clinical Infectious Diseases, 61(4), pp. 1–13, 2020, [Online]. 30, 2020).

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Drug Target Review

MAY 7, 2024

AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. By leveraging AI technologies, we could create a more accessible and equitable approach to clinical trials, breaking down barriers to participation and ensuring diverse representation among participants.

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Disease Clinical Trials Clinical Pharmacology Trials 59

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. She previously served as the VP and AVP of Operations and Innovation since August 2020.

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Perficient: Drug Development

JANUARY 9, 2024

From algorithms that can quickly surface patterns in clinical trials that can be further investigated by data managers to the consumer care staff member who can quickly access the right information at the right moment. Consumers’ willingness to provide their health data to organizations outside of their health system has declined since 2020.

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PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Vial

MAY 22, 2024

Introduction Veeva Systems and Vial CRO ( contract research organization ) represent stakeholders in the clinical research landscape, which play integral roles in the successful execution of clinical trials. Overview of Veeva Systems Veeva Systems Inc. In 2021, Gassner transformed Veeva into a public benefit corporation (PBC).

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Drug Target Review

OCTOBER 26, 2023

Nature 578 , 229-236 (2020). Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial. Nature Reviews Genetics 21 , 255-272 (2020). References Doudna JA. The promise and challenge of therapeutic genome editing.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. Inspections went down—way down—during the pandemic.

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