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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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? During the webinar, Dr. Vornov discussed a few developments in targeted CNS delivery, which are summarized below.

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Trials Drug Delivery Drugs Gene 83

Worldwide Clinical Trials

MAY 24, 2022

Join us as we celebrate cancer research awareness month and clinical trials awareness month. And they have Young Investigator Awards, which provide seed money for these young investigators as they’re developing their labs. Life after cancer is about more than just survival. Building Bridges. Every Patient Is Precious.

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Clinical Trials Clinical Trials Research Trials 130

FDA Law Blog

JULY 17, 2024

Peter Marks and Patrizia Cavazzoni, spans across both Centers, and will collaborate with the Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.

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Production Genetics Development Drugs 105

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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The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. (Alume) announced today that it has been awarded a $2.5M About Alume Biosciences, Inc.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

XTalks

APRIL 27, 2021

The device is called the IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) and has been developed by Neurolutions Inc. , a medical device company focused on developing neurological rehabilitation solutions leveraging patients’ own brain activity to facilitate motor recovery and restore function.

Radiology 105

Radiology Development FDA Approval Containment 105

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.

Radiology 52

Radiology Cardiology Development Production 52

XTalks

SEPTEMBER 9, 2022

The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. The SAINT Neuromodulation Trial. The FDA granted Breakthrough Device Designation to Magnus Medical for the SAINT technology back in November 2021.

Radiology 98

Radiology Life Science Licensing Licensing 98

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD).

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XTalks

JANUARY 26, 2024

Key breakthroughs at the forefront include novel approaches to cancer treatment and diagnosis, the integration of artificial intelligence (AI) in oncology and the development of advanced preventive measures and care. Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs.

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The Pharma Data

MAY 16, 2021

After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine. 1.351 (South African) variants. Department of Health and Human Services in collaboration with the U.S.

Immune Response 52

Immune Response Vaccine Vaccination Trials 52

pharmaphorum

SEPTEMBER 8, 2022

Furthering DiME’s previous work on digital clinical measures, nocturnal scratch’s more widespread implementation aims to establish a firmer digital groundwork for future clinical research, technology development, and reimbursement decisions in the dermatological field, and thereby improve the lives of AD patients and caregivers.

Dermatology 52

Dermatology Production Radiology Development 52

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. Further, more than 50% of the patients develop long-term neurologic deficits.

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Marketing Hormones Radiology Pharma Companies 77

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

pharmaphorum

MARCH 31, 2021

Novartis hopes to use the biomarker to develop both imaging agents for cancer and potentially therapeutics to direct cell-killing radiotherapy to tumours. billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial. In 2018 it paid $2.1

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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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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

Cloudbyz

JULY 31, 2024

In this blog, we will explore how diagnostics play a pivotal role in these cutting-edge fields, enhancing patient outcomes, and accelerating the development of personalized treatments. This enhances the identification of biomarkers and the understanding of disease mechanisms, accelerating the development of targeted therapies.

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Gene Therapy Gene Medicine In-Vitro 52

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

MARCH 30, 2021

The device has been developed by Helius Medical Technologies and is approved in Canada and the EU, with the US now following suit with the FDA authorization. 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 press announcement from the agency.

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Radiology Trials Marketing Containment 71

XTalks

FEBRUARY 10, 2021

Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health, in a FDA news release. How it Works.

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Radiology Marketing Clinical Trials Clinical Trials 97

The Pharma Data

OCTOBER 22, 2020

The speed and rigor with which Veklury has been developed and approved in the U.S. 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. to 2.48; p=0.017).

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

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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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.

Compliance 52

Compliance Clinical Trials Clinical Trials Trials 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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XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. The company reported an investment of $2.7

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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.

Clinical Trials 52

Clinical Trials Clinical Trials Sales Drugs 52

The Pharma Data

OCTOBER 14, 2020

Felker and Dr. Udelson join current advisors to support the development ofalfapump ® DSR for the management of fluid overload in patients with heart failure. The Sequana Medical management team is working closely with its advisors on the development of alfa pump DSR (Direct Sodium Removal). GHENT, Belgium, Oct.

Cardiology 40

Cardiology Clinical Trials Clinical Trials Medicine 40

pharmaphorum

APRIL 7, 2021

billion-plus alliance with UK biotech Artios Pharma to develop precision medicines for cancer. billion along with its developer Advanced Accelerator Applications in 2017. In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 The drug made $445 million in sales last year.

DNA 52

DNA Licensing Licensing Gene Therapy 52

The Pharma Data

DECEMBER 9, 2020

. “Of all the organs in our body, the brain is the one most easily damaged by a poor diet,” said Dr. Lisa Mosconi, director of the Women’s Brain Initiative and an associate professor of neuroscience in neurology and radiology at Weill Cornell Medicine and NewYork-Presbyterian Hospital. So, what does work?

Radiology 52

Radiology Research Containment Medicine 52

Intouch Solutions

SEPTEMBER 27, 2024

The discourse wasn’t just about cycling through tissue or aiding clinical development; it ranged from mutation prediction to tumor microenvironment (TME) analysis to how AI can aid in diagnosis and treatment planning to achieve better outcomes for patients. Hi, I am Barry Vuscko, SVP of Strategic Development.

DNA 59

DNA Trials Antibody Marketing 59

The Pharma Data

AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The major efficacy endpoint for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 WELIREG is the first HIF-2?

Hormones 52

Hormones Clinical Trials Clinical Trials Trials 52

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. How personalized, targeted assays can be developed to detect somatic mutations from cfDNA. “A percent show less reliability).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

AUGUST 9, 2022

The software is combined with traditional MRI scanning to improve the “accuracy and speed” of prostate cancer diagnosis by improving the diagnostic resolution of images, according to the company, which makes it available as a software-as-a-service (SaaS) to radiology departments.

Radiology 83

Radiology FDA Approval Clinical Trials Clinical Trials 83

WCG Clinical

SEPTEMBER 23, 2024

However, growing numbers of clinical trials are now using both diameter and volumetric measurements to assess treatment response, with the two kinds of measurements at times producing strikingly different results. In addition, we are now introducing metabolic and functional information from molecular imaging methods. guidelines.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

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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