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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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

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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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

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.

Molecular Biology 52

Molecular Biology Laboratories Engineering Hospitals 52

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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Vaccine Clinical Trials Virus Science 52

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. About Critical Path Institute.

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The Pharma Data

MARCH 11, 2021

EMPACTA (Evaluating Minority Patients with Actemra) is a phase III, randomised, double-blind, placebo-controlled multicentre study (EMPACTA, NCT04372186) which evaluated the efficacy and safety of Actemra/RoActemra in the treatment of hospitalised COVID-19 pneumonia among patients that are often underrepresented in clinical trials.

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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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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.

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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. 2005; 49(3):873-883. Find out more about HOOKIPA online at www.hookipapharma.com. __.

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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

JANUARY 6, 2021

Our proprietary recombinant human alkaline phosphatase has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. Nephron Clinical Practice, 2014; 127 (1-4): 30-34. Journal of the American Society of Nephrology, 2005; 16(11): 3365-3370.

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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. Lung Cancer.

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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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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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Alta Sciences

APRIL 17, 2024

Our experts align the appropriate bioanalytical approach with the goals of the oligonucleotide drug development program, based on its size/type, the sensitivity and specificity required, as well as throughput needed based on the preclinical or clinical phase of the drug in development.

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The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR and the PATHFINDER clinical trial program Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE. 4,5 The program includes additional planned mechanistic and long-term safety trials. 2005; 172; 149–60. J Intern Med 2012;272:121–32.

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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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Agency IQ

FEBRUARY 2, 2024

In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. Prognostic biomarkers enable patient selection that would have a better clinical outcome irrespective of treatment. This enables patient selection, stratification and other adjustment in clinical trial design planning.

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Agency IQ

APRIL 19, 2024

To this end, the IMWG added new response categories of minimal residual disease (MRD) negativity to add an additional layer of depth to outcomes reporting both within and outside of clinical trials. VOTING QUESTION: Does the evidence support the use of MRD as an accelerated approval endpoint in MM clinical trials?

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The Pharma Data

DECEMBER 21, 2020

PATHFINDER Clinical Trial Program Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, the registrational NAVIGATOR study and SOURCE. 12-15 The program includes additional planned mechanistic and long-term safety trials. 2005; 172: 149-160.

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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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Production Government Marketing Regulations 52

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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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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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). Since 2005, Janssen Vaccines & Prevention B.V.

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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.

Disease 40

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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. Journal of Obesity. 2011;2011:651936. DOI: 10.1155/2011/651936. . Daubenmier J, Moran PJ, Kristeller J, et al. Effects of a mindfulness?based Obesity (Silver Spring, Md). 2016;24(4):794-804. DOI: 10.1002/oby.21396.

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Alta Sciences

MARCH 4, 2025

We are the leading organization in conducting substance abuse clinical trials, with principal investigators who collectively bring over 50 years of experience in the field of substance abuse, and with a team of physicians who have extensive expertise in identifying participants for substance abuse studies.

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PPD

MARCH 26, 2025

In the summer of 2005, I got a phone call that changed my life forever. Being a clinical researcher, I appealed to my colleagues in neuroscience for their thoughts on my symptoms. Through strategically designed clinical trials, we are assessing the safety, efficacy and long-term potential of this therapy to alter disease progression.

Research 52

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New Drug Approvals

MARCH 31, 2025

1] [2] As of December 2024, it is in phase 2 clinical trials for Alzheimer’s disease and obesity. [1] In addition, evidence from animal and clinical trials suggests that MAO-B inhibitors have a brain protective effect, unlike other drugs. [5]The 1] [2] [3] [4] It is taken by mouth. [1]

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Drug Target Review

NOVEMBER 27, 2024

Since 2005, he has played a vital role in ensuring that laboratory data meets rigorous quality standards and complies with industry regulations. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. 2022 Mar 5;112(1):69–80. Chapman and Hall/CRC, 2019.

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Drug & Device Law

JANUARY 15, 2024

Indeed, in making [defendant’s] failure to conduct clinical trials or studies of the [product] a central theme of their case, plaintiffs “opened the door” to the admission of 510(k) evidence, notwithstanding the trial court’s exclusion. [We] Ethicon, Inc. , 3d 1245 (N.J. 2d at 1013-14. Similarly, in Forrest v. Beloit Corp. ,

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