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

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

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 Phase III results support the ongoing development of rezafungin based on efficacy and safety.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

The Pharma Data

MARCH 23, 2023

1,2 Darolutamide is already approved under the brand name Nubeqa TM for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer (mHSPC).

Hormones 40

Hormones Trials Branding Development 40

XTalks

APRIL 7, 2021

COVID-19 antibody tests can help identify people who may have had prior COVID-19 infection, and importantly, asymptomatic individuals with a developing or current infection. The tests do not detect the SARS-CoV-2 virus itself, and hence should not be used for diagnostic purposes.

Antibody 102

Antibody Immune Response Radiology Marketing 102

Drug Discovery World

JANUARY 24, 2023

But Jeffrey Petrella, Professor of Radiology and Director of the Alzheimer Imaging Research Laboratory at Duke University School of Medicine, says: “Despite these limitations, this is the first step towards tailored clinical trials.

Clinical Trials 97

Clinical Trials Clinical Trials Drugs Trials 97

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. About the author.

Development 98

Development Regulation Cosmetics Life Science 98

Delveinsight

SEPTEMBER 2, 2021

According to DelveInsight’s Neuromodulation Devices Market Analysis , the approval of this device will drive the market growth as around seven million people in the United States are currently living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.

Marketing 72

Marketing Radiology Drugs Drug Delivery 72

pharmaphorum

MARCH 11, 2021

Estimates of medical diagnostics worth to the UK vary – MedTech Europe puts its value at around £1billion while the Office for Life Sciences reported in 2018 that it accounts for around 27% of the £24 billion turnover generated annually by the UK’s medtech sector.

In-Vitro 60

In-Vitro Containment Radiology Life Science 60

XTalks

MAY 13, 2022

This involves careful selection and development of packaging systems with considerations of stability, storage, accelerated aging, freeze-thaw, altitude, drop, vibration distribution simulation, as well as identification and characterization of compounds released from packaging materials (i.e. shaking, changes in pressure, etc.).

Packaging 98

Packaging Packaging Containment Production 98

XTalks

NOVEMBER 7, 2022

In addition, Dr. Bahassi stressed that the simple enumeration of CTCs will not contribute significantly to the development of improved or more personalized cancer treatments. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

DECEMBER 23, 2020

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). It will be funded by the U.S. Department of Defense.

DNA 40

DNA Vaccination Vaccine Immune Response 40

XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Why is it Difficult to Develop CNS Therapeutics? Intrathecal Drug Systems are an Important Pain Treatment Modality.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

JULY 13, 2022

Around one in three adults in the US (or about 80 million Americans) are at risk of developing CKD. “The work conducted in collaboration with the leadership at the FDA’s Center for Devices and Radiological Health facilitated the development of AI innovation that will now deliver better digital health to the American public.

Reagent 98

Reagent In-Vitro Radiology Life Science 98

The Pharma Data

NOVEMBER 19, 2020

Previously, she was head of Business Development at Cubist Pharmaceuticals. Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire. Day Zero – Dekel Gelbman was named senior vice president of Business and Development Strategy for Day Zero Diagnostics, Inc. Cogentus Pharmaceuticals, Inc.,

Life Science 52

Life Science Research Development Radiology 52

XTalks

MARCH 10, 2021

Along with COVID-19 vaccine authorizations, the US Food and Drug Administration (FDA) remains committed to increasing access to COVID-19 tests and supporting their development, having authorized three new tests recently for emergency use. The products encompass molecular, antigen and T cell-based testing approaches.

Protein 98

Protein RNA Antibody Production 98

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

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

pharmaphorum

MARCH 16, 2021

The use of real-world evidence is proving beneficial for pharma and medical devices companies across the lifecycle of development from R&D to re-purposing. There are a good number of use cases as to why pretty much every big life science company is choosing us these days,” says Medrano. AI use in the pandemic. About Savana.

Doctors 112

Doctors Doctor Life Science Clinical Research 112

XTalks

SEPTEMBER 14, 2020

And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The company is also in collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral treatment for COVID-19. helped protect COVID-19 patients against developing severe disease.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92