Drug Target Review

MARCH 3, 2025

This approach has the potential to revolutionise clinical trial design and lead to more effective, personalised treatments. Meet Professor Jens Christian Schwamborn In 2002, Jens obtained a diploma in Biochemistry from the University of Witten/Herdecke in Germany and in 2005 a PhD in Biology from the University of Muenster in Germany.

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The Pharma Data

SEPTEMBER 23, 2020

It will ask manufacturers who seek an emergency authorisation to follow participants in late-stage clinical trials for a median of at least two months, beginning when they received a second vaccine shot, according to two people who spoke to The Post anonymously. . The FDA has only granted Emergency Use Authorization for a vaccine once before.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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Vial

MAY 8, 2024

The widespread adoption of EDC technology has revolutionized clinical operations , offering benefits such as improved data management, reduced trial timelines, remote monitoring capabilities, and enhanced data security. Vial seeks to transform clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes.

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The Pharma Data

MARCH 5, 2021

The FDA approval is based on data from the focuSSced trial, a Phase III randomised, double-blind, placebo-controlled clinical trial of 212 adults with systemic sclerosis. Supportive information was also used from the faSScinate trial, a Phase II/III, randomised, double-blind, placebo-controlled study in patients with SSc.

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The Pharma Data

FEBRUARY 22, 2022

He is co-founder and non-executive board member of the Hartwig Medical Foundation (large scale DNA analyses) and is a board member of the Center for Personalized Cancer Treatment and leads several innovative precision oncology clinical trials. Emile Voest obtained a PhD in medicine from the University of Utrecht.

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Drug Target Review

SEPTEMBER 20, 2023

How AI/ML technology has accelerated drug discovery Although AI for drug discovery (AIDD) can be viewed as being in the initial phases of development and acceptance, compounds discovered using AIDD platforms are already entering clinical trials.

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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. Chem Immunol Allergy 86:151-183 (2005). Human γδ TCR repertoires in health and disease.

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Drug Target Review

DECEMBER 15, 2023

Once it has learnt to do the task reliably, the researchers could observe which nodes are used at different moments in the trial, as one cluster of nodes may encode available routes. 2005 March 7 [2023 November 22]; 158(1):175-82. Real human brains and the system use the same tricks when required to perform the task.

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Alta Sciences

OCTOBER 9, 2024

Since 2005, the PharmaVoice 100 has become one of the publication’s most anticipated features. Each winner represents the transformative impact of the pharmaceutical industry in their own unique way. We are excited to recognize their contributions through this annual list,” said Meagan Parrish, Lead Editor, PharmaVoice.

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The Pharma Data

NOVEMBER 22, 2021

Since 2005, AstraZeneca has achieved an nearlysix-fold enhancement in the proportion of its channel motes that have advanced from preclinical disquisition to completion of Phase III clinical trials – from 4 to 23. This enhancement moves AstraZeneca well above the current assiduity average success rate of 14 in the 2018-2020 timeframe.4.

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The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec. About Critical Path Institute.

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Alta Sciences

APRIL 17, 2024

Fifteen oligonucleotides have so far received market authorization in different countries, and several others are being test in clinical Phase I to III trials. The first GLP-1RA for the treatment of Type 2 Diabetes (T2D) was approved in 2005 , supported by data that showed GLP-1 stimulated insulin secretion.

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The Pharma Data

MARCH 17, 2022

Since 2005, AstraZeneca has achieved an almost six-fold improvement in the proportion of its pipeline molecules that have advanced from preclinical investigation to completion of Phase III clinical trials – from 4% to 23%.

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New Drug Approvals

DECEMBER 3, 2022

1] [6] Navitoclax entered clinical trials , [1] [6] and showed promise in haematologic cancers , but was stalled when it was found to cause thrombocytopenia (severe loss of platelets ), which was discovered to be caused by the platelets’ requirement for Bcl-xL for survival. [1] nM, and 197.8 nM, respectively. .; Reed, John C.;

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Broad Institute

JANUARY 30, 2024

In 2005, Bhattacharyya completed PhD studies at the University of California, San Francisco, in biochemistry and molecular biology, followed by two years of medical training. Bhattacharyya is currently running a trial at MGH to test GoPhAST-R on patients’ blood samples as they are undergoing care, and the results look promising.

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The Pharma Data

JUNE 25, 2021

The FDA’s Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 Eisai serves as the lead in the co-development of lecanemab.

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The Pharma Data

JULY 29, 2021

Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

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SugarCone Biotech

MAY 28, 2019

A study, published in 2005, suggested that chloroquine could prevent SARS (the older virus) from infecting cells kept in culture. [2] 4] , [5] The drug was approved despite inconsistent Phase 3 clinical trial results, and despite the use of post-hoc analysis to identify potentially responding patients.

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Agency IQ

APRIL 19, 2024

Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials. The analysis included 20 trials for 12,926 patients with IPD.

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The Pharma Data

DECEMBER 14, 2020

Oncocyte has also launched DetermaIO , a gene expression test that identifies patients more likely to respond to checkpoint inhibitor immunotherapies, for research and pharma clinical trial use. 2 Woodard et al., 2020 North America International Association for the Study of Lung Cancer Conference Poster. 3 Shi JF et al.,

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Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. Generally, centralized testing is recommended for pivotal clinical trials.

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PLOS: DNA Science

JUNE 22, 2023

I recalled Heather’s early mastery of mitosis last week when the news reported promising clinical trial results for a cancer drug for brain tumors that targets a protein, called survivin , that controls the cell cycle. She chronicled her journey in Glamour and in My So-Called Normal Life, a book published in 2005. Blood cancer.

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The Pharma Data

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

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The Pharma Data

JANUARY 19, 2021

to continue to build its preclinical research and development platform on retinopathies and for other new and on-going research and development activities, working capital and other general corporate purposes. The securities referred to in this press release will be offered only by means of a prospectus filed with the SEC.

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DrugBank

JUNE 27, 2023

Modern advances in “omics,” as well as biomarker development, clinical trial design, and mathematical modelling (including artificial intelligence) have revolutionized our ability to precisely define or “stratify” patient populations, splitting them into groups based on their characteristics.

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Agency IQ

NOVEMBER 20, 2023

Later, in 2005, the FDA first cleared a blood irradiator for two indications: to reduce the risk of graft-versus-host disease (GVHD) in transfusion scenarios and for the prevention of metastasis. I can’t imagine that someone is going to design a trial that is going to look at these things in such a small-use patient population.”

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The Pharma Data

AUGUST 13, 2020

We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

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The Pharma Data

AUGUST 13, 2020

We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

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Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. For clarity, the current alpha-numeric system is used here.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. In these situations, as the drug product is still under development, manufacturing processes may still be changing, and stability testing may be only in the early stages.

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Codon

APRIL 9, 2024

After confirming they experienced no side effects, Tu and her colleagues carried out the first clinical trial on human patients in Hainan between August and October 1972, which continued to demonstrate qinghao extract’s high efficacy. It was only in 2005, after the emergence of widespread resistance of P.

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The Pharma Data

AUGUST 31, 2021

Johnson & Johnson (NYSE: JNJ), together with a consortium of global partners, today announced results from the primary analysis of a Phase 2b HIV vaccine clinical trial known as the Imbokodo study (also known as HVTN 705/HPX2008). 1] The study took place at 23 trial sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe.

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The Pharma Data

FEBRUARY 1, 2021

For example, a 2005 review published in The Lancet Neurology about clinical trials in postmenopausal women 65 or older showed women who received hormone therapy, including estrogen, had an increased risk for dementia and other types of cognitive decline.

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The Pharma Data

MAY 13, 2021

based weight loss intervention in adults with obesity: A randomized clinical trial. 2005 Dec;25(12):2451-62. Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial. DOI: 10.1155/2011/651936. . 2016;24(4):794-804.

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National Institute on Drug Abuse: Nora's Blog

MAY 31, 2023

In 2021, just 12% of people were current smokers, down from 21% in 2005. In the United States, smoking continues to decline in most groups. But with one in five deaths each year attributable to smoking, we still have a long way to go.

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