The Pharma Data

MARCH 22, 2021

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.

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Trials Vaccination Vaccine Radiology 52

pharmaphorum

DECEMBER 15, 2022

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

Radiology 59

Radiology FDA Approval Licensing Licensing 59

Pharmaceutical Technology

NOVEMBER 30, 2022

Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m Additionally, the funds are intended to advance the vaccines to successful conclusion of Phase I clinical trials. in milestone payments.

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The Pharma Data

FEBRUARY 21, 2022

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

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The Pharma Data

DECEMBER 14, 2020

The Phase II SBIR grant is a follow-on 2–year award that will support testing of Alume’s fluorescent nerve targeting agent in an ongoing Phase 1/2 clinical trial in patients undergoing Head and Neck Surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use.

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Clinical Trials Clinical Trials Trials Radiology 52

Worldwide Clinical Trials

MAY 24, 2022

Join us as we celebrate cancer research awareness month and clinical trials awareness month. What I like about my role at Worldwide Clinical Trials is that feeling that I am close to the patient, as I am often involved in confirming the patient’s eligibility on the study, understanding how patients are responding to the drug.

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Delveinsight

DECEMBER 29, 2020

Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The Food and Drug Administration (FDA) decided to lift the clinical ban from Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. . The post A USD 4.2

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Scienmag

FEBRUARY 16, 2021

Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community” A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical […].

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XTalks

MARCH 27, 2023

The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. Once the fungus cannot synthesize β-(1, 3)-D-glucan, it undergoes osmotic instability and cell death.

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Clinical Trials Clinical Trials Branding Trials 98

Scienmag

SEPTEMBER 18, 2020

ARRS promises to deliver the same clinically relevant experience for which its Annual Meeting has long been heralded: world-class educational activities led by the field’s foremost experts that span every subspecialty of radiology Leesburg, VA, September 18, 2020–The American Roentgen Ray Society (ARRS) will convene its 2021 Annual Meeting (..)

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Radiology Clinical Trials Clinical Trials Gerontology 47

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We What is Contrast-Enhanced Mammography (CEM)?

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Drug Discovery World

NOVEMBER 29, 2023

These findings closely matched the results of the corresponding real-life clinical trials. The most important benefit is that we now have an accurate model that we can use to perform virtual experiments with different types of interventions, quickly and digitally.”

Development 52

Development Drugs Radiology Drug Trials 52

pharmaphorum

JANUARY 17, 2023

Greater Manchester has been selected as the site for the trial, as rates of lung cancer there are among the highest in the UK, said the partners. qXR has been trained on more than 2 million X-rays and their corresponding radiology reports, using deep-learning algorithms to interpret the images. The pilot will run for six months.

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Radiology Pharma Companies Trials Marketing 110

XTalks

SEPTEMBER 9, 2022

The SAINT Neuromodulation Trial. The results of the double-blinded randomized controlled trial (RCT) that assessed the SAINT technology for treating depression were published in October 2021 in the American Journal of Psychiatry.

Radiology 98

Radiology Life Science Licensing Licensing 98

The Pharma Data

MARCH 24, 2021

Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021. The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial. D8110C00001 1.

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Radiology Vaccination Vaccine Trials 52

Drug Discovery World

JANUARY 24, 2023

Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3.

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Clinical Trials Clinical Trials Drugs Trials 97

pharmaphorum

SEPTEMBER 22, 2021

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health.

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In-Vitro Radiology Regulation Trials 108

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

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Radiology Marketing Genome Genomics 111

XTalks

NOVEMBER 29, 2022

The study results will be presented at the Radiological Society of North America annual meeting , which is currently being held in Chicago, IL until December 1, 2022. XTALKS WEBINAR: Getting Neuroimaging Right — How to Succeed in Neurodegenerative Clinical Trials. What is ADHD and How is it Diagnosed?

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Development Radiology Clinical Trials Clinical Trials 97

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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Radiology Production Regulation Manufacturing 40

pharmaphorum

SEPTEMBER 8, 2022

Later today , Matthew Diamond, chief medical officer for digital health at the FDA’s Center for Devices and Radiological Health (CDRH), will – along with Thorsten Vetter, senior scientific officer at the European Medicines Agency (EMA) – outline and highlight each of the new resources.

Dermatology 52

Dermatology Production Radiology Development 52

Cloudbyz

APRIL 4, 2023

Source documents and case report forms (CRFs) are two types of documents that are commonly used in clinical trials to collect clinical data. On the other hand, CRFs are electronic forms used to collect and manage clinical data in clinical trials.

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Clinical Trials Clinical Trials Containment Radiology 52

The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 Dr. Olaf Weber, Head of Radiology Research and Development at Bayer.

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Radiology Life Science Development Production 52

The Pharma Data

JANUARY 27, 2021

The good news is that, more recently, “our ongoing surveillance and research suggests that there has been a rebound in [cancer] trial launches,” Lamont said. “This study speaks to a big decline in the launch of new trials during the pandemic,” Schilsky noted. “Some trials never resumed and may never.

Research 52

Research Trials Radiology Scientist 52

WCG Clinical

MARCH 17, 2023

But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively? If most items cannot be billed to insurance and there are no funds to cover those costs, then it’s time to make a decision about the financial feasibility of conducting the trial.

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Compliance Clinical Trials Clinical Trials Trials 52

The Pharma Data

MARCH 23, 2023

Darolutamide has already demonstrated efficacy and safety in nmCRPC with the Phase III ARAMIS trial, and in mHSPC with the Phase III ARASENS trial. The primary endpoint of this study is radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review.

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Hormones Trials Branding Development 40

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Trials Drug Delivery Drugs Gene 83

XTalks

JANUARY 26, 2024

Clinical trials have demonstrated the potential of CRISPR/Cas9 in this field. Personalized medicine: One of the most exciting prospects of CRISPR/Cas9 in oncology is its contribution to personalized medicine. By tailoring treatments based on an individual’s genetic makeup, it may allow for more effective and targeted therapies.

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Research Gene Editing Gene Genetics 118

Drug Discovery World

APRIL 8, 2024

Ichnos Glenmark Innovation Ichnos Glenmark Innovation (IGI), an alliance between Ichnos Sciences and Glenmark Pharmaceuticals, shared pre-clinical data for its oncology asset ISB 2001, which is currently being tested in a Phase I clinical trial in relapsed/refractory multiple myeloma (r/r MM).

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In-Vivo In-Vitro Antibody Protein 52

XTalks

APRIL 27, 2021

Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement from the agency. This included data from an unblinded study of 40 stroke patients over a 12-week trial.

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Radiology Development FDA Approval Containment 105

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. Evusheld was generally well-tolerated in the trials.

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Delveinsight

SEPTEMBER 27, 2021

It can be due to the previous existence of brain damage signs (psychomotor retardation, neurologic signs, radiologic signs, or other types of seizures) or on the basis of etiology that is characterized by a lack of previous signs of brain damage. There are many different causes of epileptic spasms.

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Marketing Hormones Radiology Pharma Companies 77

Drug Discovery World

OCTOBER 24, 2022

The researchers say their next step is large animal trials and if successful, they look toward a Phase I clinical trial in humans. . “That makes us think that this approach might actually work better than external beam therapy for many other cancers, too.” .

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Engineer Clinical Trials Clinical Trials Trials 74

The Pharma Data

OCTOBER 22, 2020

reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. The ACTT-1 trial results are complemented by results of two Phase 3 open-label trials of Veklury conducted in adult patients with severe and moderate COVID-19.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). The half-life extension more than triples the durability of its action compared to conventional antibodies;(11-13) data from the PROVENT Phase III trial show protection lasting at least six months.(14) Evusheld was well-tolerated in the trials. W911QY-21-9-0001.

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

pharmaphorum

SEPTEMBER 30, 2022

First and most obviously is the detailed data from the Clarity AD study reported this week, which will be revealed at the Clinical Trials on Alzheimer’s Congress (CTAD) in November. There will still be much debate about the exact license granted to the drug and cost-effectiveness deliberations, according to Prof Passmore.

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Clinical Trials Clinical Trials Sales Drugs 52

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . PLYMOUTH MEETING, Pa. ,

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