Drug Discovery World

FEBRUARY 8, 2023

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. It also showed that GSK trial enrolment for each condition differed by race and ethnicity.

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The Pharma Data

MAY 27, 2022

billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8

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Creative Biolabs

JANUARY 15, 2020

By understanding the mechanism of new product development, product screening and production processes, as well as the diseases and symptoms that drugs need to treat, CDER provides scientific and regulatory advices for products that are about to be brought to market.

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The Pharma Data

MAY 31, 2022

the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of of BRT-DA01 in patients with Parkinson’s disease.?. preliminary?efficacy?of

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PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” The issue of including diverse populations that represent disease prevalence and country and regional demographics is not new to industry.

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BioPharma Drive: Drug Pricing

AUGUST 28, 2023

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

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Drug Discovery World

JANUARY 2, 2024

A promising treatment option, JAK inhibitors act by blocking the JAK family kinases and inhibiting the inflammatory pathways involved in AD and other inflammatory diseases. They reviewed the available safety data and analysed the risk of 11 adverse events from 14 RCTs published between 2019 and 2022.

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Drug Discovery World

JANUARY 19, 2023

A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint. million related deaths globally. “The trial shows promising positive results across a variety of primary and secondary endpoints.

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Drug Discovery World

FEBRUARY 12, 2024

There was great fanfare recently for a new Alzheimer’s drug, lecanemab (brand name Leqembi), which was shown in a trial to reduce the rate of cognitive decline in people with mild impairment. After all, these failures come on top of decades and decades of research into these diseases. Why has there been so little progress in medicine?

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Drug Discovery World

JANUARY 8, 2024

The first clinical-trial results for the compound are expected this year. 1 The second molecule, murepavadin, also targets Gram-negative pathogens through lipopolysaccharide transport (Lpt) proteins, though it yet to enter human trial. Government incentives provide one solution.

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Drug Discovery World

OCTOBER 18, 2023

Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas. 4 Unfortunately, many AAV-based gene therapies fail during clinical trials, despite them appearing safe and efficacious in preclinical studies.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

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Drug Discovery World

APRIL 11, 2023

12 The trial Tezepelumab was well tolerated in patients with severe asthma and resulted in clinically meaningful reductions in asthma exacerbations in NAVIAGTOR & SOURCE clinical trials and no clinically meaningful differences in safety results between the tezepelumab and placebo groups. 2019 May 23;380(21):2082].

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Drug Discovery World

NOVEMBER 1, 2022

Its snapshot report aimed to provide both an overview of the sector in Australia to determine how the sector has changed since this data was collected in 2017 and 2019 2. . The number of employees behind our biotech companies has also expanded, increasing 21% compared with 2019 from approximately 87,397 people in 2019 to 105,569 in 2022.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. In my case, my daughter Iris has GM1 gangliosidosis.

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Drug Discovery World

FEBRUARY 8, 2023

Dengue is the fastest spreading mosquito-borne virus and was recognised by the World Health Organization (WHO) in 2019 as one of the top ten threats to global health. An estimated 3.9

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Drug Discovery World

SEPTEMBER 27, 2023

Seven years of trial data DLd is licensed and has been available for use in Europe since 2019. The positive Final Draft Guidance (FDG) follows a positive acceptance from the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland this month.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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Drug Discovery World

SEPTEMBER 26, 2022

The approval by the European Commission was based on results from the Pathfinder clinical trial programme, which included the pivotal Navigator Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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Drug Discovery World

APRIL 23, 2024

Over the past 20 years research has increasingly linked concussions to neurogenerative conditions, including dementia, Alzheimer’s disease and CTE, a degenerative brain disease. More than 413,000 service members were diagnosed with a TBI between 2000 and Q3 of 2019. Over 80% of these were concussions.

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. Here at FAB our proprietary approach aims to overcome this fundamental challenge to human health as we work to discover and develop new drugs for age-associated diseases.”

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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. Mediators of Inflammation. 2017;2017:1–15.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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Drug Discovery World

JULY 1, 2024

Following a trip to Copenhagen, Denmark, DDW’s Megan Thomas reflects on the Novo Nordisk Foundation’s efforts to tackle cardiometabolic diseases. The World Health Organization (WHO) reports that cardiovascular diseases (CVDs) are the leading cause of death globally, stating that an estimated 17.9 million ($3.4 million ($3.4

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Drug Discovery World

NOVEMBER 24, 2022

Despite the importance of the pharmaceutical industry to national economies and population health, the report paints a picture of falling competitiveness, with the global share of R&D investment, clinical trials and manufacturing output all decreasing. . Overall clinical trial activity in the region is also on the decline.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. Amsterdam: The centre of European life sciences As a result of the UK withdrawing from the EU, in 2019 the EMA headquarters was moved from London to Amsterdam.

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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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Drug Discovery World

NOVEMBER 7, 2022

EP : The Psychiatry Consortium, launched in 2019, is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. . Why do you think that is? .

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . adults have been diagnosed with dry eye disease, a chronic, episodic, multifactorial disease. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

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The Pharma Data

JULY 22, 2021

NOTE: ADUHELM TM (aducanumab-avwa)injection 100 mg/mL solutionis indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Biogen Inc.

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Quanticate

JUNE 16, 2020

The leading cause of death in patients with coronavirus disease 2019 (COVID-19), caused by the virus ‘severe acute respiratory syndrome coronavirus 2’ (SARS‑CoV‑2), is respiratory failure from acute respiratory distress syndrome. [1]

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The Pharma Data

NOVEMBER 10, 2020

P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. Crohn’s Disease Therapeutics Market Size $4.7 The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Billion by 2025. NEW YORK and LONDON, Nov.

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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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Drug Discovery World

SEPTEMBER 7, 2022

From research to clinical trials, FDA assessment and monitoring beyond, the process is by no means quick; anything that helps expediate the route for getting a drug to market is desirable. According to MarketsandMarkets the global AI in drug discovery market is projected to reach $1,434 million by 2024 from $259 million in 2019.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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