Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Broad Institute

AUGUST 19, 2024

A common fatty acid may help restore healthy vaginal bacteria after infection By Ari Navetta August 19, 2024 Breadcrumb Home A common fatty acid may help restore healthy vaginal bacteria after infection Treatments using oleic acid, a naturally occurring oil used in cells, could improve treatment of recurrent bacterial vaginosis infections.

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The Pharma Data

NOVEMBER 30, 2020

The UK-based RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients. They said it is likely to be several months before colchicine’s efficacy is known. Source link.

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Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.

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PPD

OCTOBER 17, 2024

In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market.

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Drug Target Review

DECEMBER 16, 2024

Despite challenges as a woman in the field, Dr Hingorani built a career focused on advancing treatments for pediatric and adult cancers. This field allowed me the privilege of tending to children in the hospital and building long-term relationships with them and their families.

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KIF1A

MAY 29, 2024

Fortunately, Sloane does not currently have epilepsy, and Megan hopes this treatment will prevent it’s onset as her disease progresses. On the day of the treatment, they checked into the hospital where Sloane was administered sedation medication. The post Sloane’s 1st ASO treatment appeared first on KIF1A.

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The Pharma Data

JANUARY 26, 2021

Zydus Cadila Healthcare’s Desidustat has demonstrated efficacy in a phase 2b clinical trial in Mexico for COVID-19 patients hospitalized with hypoxia. Zydus has two ongoing phase 3 trials evaluating Desidustat for treatment of anemia linked to chronic kidney disease and chemotherapies. Source link.

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The Pharma Data

JANUARY 14, 2021

UK drugmaker Synairgen has dosed the first patient in a global phase 3 trial evaluating an inhaled formulation of interferon beta-1a, SNG001, for treating hospitalized COVID-19 patients who require supplemental oxygen. Source link.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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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.

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Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.

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The Pharma Data

NOVEMBER 25, 2020

The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. Background Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. Researchers evaluated the clinical status of subjects on Day 11.

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The Pharma Data

OCTOBER 15, 2020

In just six months, the world’s largest randomized control trial on COVID-19 therapeutics has generated conclusive evidence on the effectiveness of repurposed drugs for the treatment of COVID-19. Newer antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies are now being considered for evaluation. .

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On Medicine

MAY 17, 2023

When health research is published, we tend to focus our minds on the findings and consider the implications for future treatments. Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part.

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The Pharma Data

SEPTEMBER 1, 2020

. Sanofi and Regeneron’s rheumatoid arthritis drug Kevzara (sarilumab) has failed to hit targets in a late-stage trial involving patients hospitalised with COVID-19, signalling the end of its development in this area. Source link.

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Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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The Pharma Data

DECEMBER 20, 2020

Followed by Russia , Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy on Friday, December 18, 2020. Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.

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The Pharma Data

SEPTEMBER 30, 2020

image copyright Leicester’s Hospitals Trust. A baby who was suffering with breathing difficulties following birth was able to go home a week later after taking part in a new hospital trial. The next morning she could breathe unaided, the hospital trust said. Latest news and stories from the East Midlands.

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Drug Target Review

JANUARY 12, 2024

How does the integration of Real-World Data (RWD) with genomic biomarker data contribute to a more comprehensive understanding of disease progression and treatment response? Biomarker information is also useful for tracking progression of the disease and treatment response. This can lead to a new treatment being offered to the patient.

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Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. Q: What was your cancer diagnosis and was treatment options were you given?

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The Pharma Data

OCTOBER 27, 2020

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. Professional. TUESDAY, Oct.

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The Pharma Data

NOVEMBER 23, 2020

FDA Authorizes Use of Monoclonal Antibody Treatment for COVID-19. 23, 2020 — A combination of two monoclonal antibodies was granted emergency use authorization (EUA) for the treatment of mild-to-moderate COVID-19, the U.S. Professional. MONDAY, Nov. Food and Drug Administration announced Saturday. said in a statement.

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Olympian Clinical Research

OCTOBER 14, 2021

If you’re thinking about joining a clinical trial, there are many benefits you could look forward to. But how can you tell if clinical trials are right for you? We’ve outlined five reasons why joining a clinical trial might be in your best interest. You’ll Get Access to New, Cutting-Edge Treatments.

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The Pharma Data

MARCH 8, 2021

Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. This press release features multimedia. This multi-center U.S.

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The Pharma Data

JANUARY 17, 2021

Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.” Once complete, Lonza will deliver cGMP material supply for the pivotal clinical trial.

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

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The Pharma Data

OCTOBER 23, 2020

A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners.

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The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

JANUARY 21, 2021

Marilyn Glassberg Csete, the Principle Investigator of this BUMCP IIT trial. “We were encouraged by the quick recovery (discharged from hospital in 5 days) [1] of the first hospitalized patient with severe COVID-19 who received Silmitasertib under an emergency IND with Dr. . FDA for the treatment of Cholangiocarcinoma.

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Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.

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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 Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. Both of the ICR’s research laboratory sites in Sutton and in Chelsea are in close proximity to the Royal Marsden Hospital sites.

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The Pharma Data

JANUARY 7, 2021

The new manufacturing facility will handle cGMP production of CA002, the Company’s proprietary peanut allergy treatment, for planned pivotal clinical trials. We are excited to progress this treatment to market so that the millions of children suffering with peanut allergy will have the choice of a safe and tolerable immunotherapy.”.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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