The Pharma Data

OCTOBER 22, 2020

The speed and rigor with which Veklury has been developed and approved in the U.S. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 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. That compared to 90.9%

In-Vitro 108

In-Vitro Radiology Regulation Trials 108

XTalks

JULY 10, 2024

” The Xpert HCV test’s development was validated through the Independent Test Assessment Program (ITAP), part of the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. The infection, if left untreated, can lead to severe health issues such as liver cancer and liver failure.

RNA 97

RNA In-Vitro Genotype Marketing 97

XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

MARCH 11, 2021

Diagnostics was never a Cinderella sector; Britain has the fifth largest in vitro diagnostics (IVD) market in Europe, not gigantic but significant nevertheless. Across the UK, radiology departments are understaffed by around 43%, while only 3% of histopathology departments have enough staff to meet clinical demand.

In-Vitro 71

In-Vitro Containment Radiology Life Science 71

The Pharma Data

MARCH 17, 2021

The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

HR 52

HR Trials In-Vitro Manufacturing 52

The Pharma Data

JUNE 25, 2021

In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% (95% confidence interval (CI): -26, 65) compared to placebo, which was not statistically significant (Table 1). The trial did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo.

Trials 52

Trials Antibody In-Vitro Medicine 52

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 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial. Christoph D.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

MARCH 25, 2022

” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. .”

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

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

The Pharma Data

OCTOBER 6, 2021

It’s the first LAAB with Phase III data demonstrating a statistically significant reduction in the threat of developing proper COVID-19 compared to placebo. In the Phase III PROVENT trial, AZD7442 reduced the peril of developing distinguishing COVID-19 by 77, compared to placebo. AZD7442 was well- let.

Antibody 52

Antibody In-Vitro Trials Development 52

The Pharma Data

NOVEMBER 18, 2021

In an analysis of the ongoing PROVENT trial assessing a median six months of party follow-up, one 300 mg IM cure of AZD7442 reduced the threat of developing characteristic COVID-19 compared to placebo by 83. About 2 of the global population is considered at increased threat of an shy response to a COVID-19 vaccine.1

Trials 52

Trials Antibody In-Vitro Vaccination 52

The Pharma Data

AUGUST 22, 2021

Preliminary ‘in vitro’ findings from investigators at Oxford University and Columbia University demonstrate that AZD7442 neutralises recent emergent SARS-CoV-2 viral variants, including the Delta variant.(1-6). In the placebo arm, there were three cases of severe COVID-19, which included two deaths. About PROVENT.

Trials 52

Trials Antibody Vaccination Vaccine 52

FDA Law Blog

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

In-Vitro 102

In-Vitro Regulation Compliance Radiology 102

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. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92