Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Pregnancy : Radiation exposure during pregnancy can potentially harm the developing fetus.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

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

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

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.

Trials 83

Trials Drug Delivery Drugs Gene 83

The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

Trials 52

Trials Development Antibody Radiology 52

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.

Clinical Trials 130

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.

Production 105

Production Genetics Development Drugs 105

pharmaphorum

OCTOBER 5, 2022

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

Antibody 110

Antibody In-Vitro Radiology Development 110

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.

In-Vitro 108

In-Vitro Radiology Regulation Trials 108

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.

Trials 52

Trials Vaccination Vaccine Radiology 52

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.

Radiology 111

Radiology Marketing Genome Genomics 111

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.

Radiology 110

Radiology Pharma Companies Trials Marketing 110

XTalks

MARCH 27, 2023

The antifungal drug was approved under Priority Review based on its Qualified Infection Disease Product designation , an incentive to promote development of antifungals for life-threatening infections. The trial was a multicenter, double-blind, double-dummy, randomized Phase III trial across 66 tertiary care centers in 15 countries.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

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

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52

Trials Antibody In-Vitro Medicine 52

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

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

The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

Trials 52

Trials Antibody In-Vitro Vaccination 52

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)?

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Antibody Vaccination Vaccine 52

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).

Production 98

Production Regulation Manufacturing Packaging 98

Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Audentes Therapeutics’ ASPIRO Trial Free to Proceed. Billion Myovant/ Pfizer Deal. mg) in the US and Canada.

Trials 52

Trials Drugs Hormones Radiology 52

WCG Clinical

SEPTEMBER 13, 2024

Given the societal impact, there is a significant amount of clinical trial work being performed to evaluate traumatic brain injury. Today, there are over 400 ongoing clinical trials. Depending on the clinical presentation of the patient, a radiologic evaluation to detect intracranial injury is performed.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

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

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.

Research 118

Research Gene Editing Gene Genetics 118

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.

Vaccination 52

Vaccination Vaccine Radiology Trials 52

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 Vaccination Vaccine 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.

Marketing 77

Marketing Hormones Radiology Pharma Companies 77

The Pharma Data

MARCH 16, 2021

AstraZeneca has modified an existing agreement with the US Government to supply up to 500,000 additional doses of AZD7442, a long-acting antibody (LAAB) combination which is in late-stage development for the prevention and treatment of COVID-19. AZD7442 is currently being assessed in five late-stage prevention and treatment trials.

Antibody 52

Antibody Trials Radiology Development 52

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

Licensing 98

Licensing Licensing Gene Therapy Sales 98

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.

Radiology 52

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

XTalks

APRIL 6, 2021

The device, developed by world-leading medical technology company Medtronic , is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation. The condition causes blood to leak backward into the right lower chamber of the heart.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98