XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

OCTOBER 22, 2020

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. The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

FDA Law Blog

OCTOBER 10, 2022

As a refresher, the Cures Act established the following four criteria for Non-Device CDS software: Criterion 1 : Non-Device CDS software functions do not acquire, process, or analyze medical images, signals from an in vitro diagnostic (IVD) device, or patterns or signals from a signal acquisition system.

Regulation 52

Regulation In-Vitro Development 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. That compared to 90.9%

In-Vitro 108

In-Vitro Radiology Regulation Trials 108

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

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

The Pharma Data

SEPTEMBER 30, 2021

director of the Office of In Vitro Diagnostics and Radiological Health within the FDA’s Center for Devices and Radiological Health. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the acceptable treatment,” said Tim Stenzel, M.D.,

Radiology 52

Radiology In-Vitro Marketing Drugs 52

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 72

In-Vitro Containment Radiology Life Science 72

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

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

MARCH 29, 2022

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1,

Antibody 52

Antibody In-Vivo Vaccine Vaccination 52

The Pharma Data

MARCH 25, 2022

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.

Antibody 52

Antibody In-Vivo Medicine Vaccine 52

pharmaphorum

OCTOBER 5, 2022

It has been shown in vitro to cover all major influenza A strains that have arisen since the 1918 ‘Spanish flu’ pandemic and is designed as a universal prophylactic for influenza A. VIR-2482 is an investigational intramuscularly administered influenza A-neutralising mAb.

Antibody 110

Antibody In-Vitro Radiology Development 110

The Pharma Data

OCTOBER 6, 2021

Primary‘in vitro’ findings demonstrate that AZD7442 demonstrates broadanti-COVID exertion, and in particular neutralises recent pressing SARS-CoV-2 viral variants, including the Delta and Mu variants. (). Notwithstanding, AZD7442 would be the first LAAB to take an EUA for COVID-19 precluding, If granted. AZD7442 was well- let.

Antibody 52

Antibody In-Vitro Trials Development 52

The Pharma Data

NOVEMBER 18, 2021

New data from the AZD7442 COVID-19 PROVENT forestallment and Paraphernalia inpatient treatment Phase III trials both showed robust efficacity from a one- time intramuscular (IM) cure of the long- amusement antibody (LAAB) combination. In both PROVENT and Paraphernalia, AZD7442 was generally well permitted.

Trials 52

Trials Antibody In-Vitro Vaccine 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 Vaccine Vaccination 52

FDA Law Blog

FEBRUARY 20, 2025

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. Mullen & Jeffrey N. Judge Jordan said he would issue a decision as soon as possible.

In-Vitro 102

In-Vitro Regulation Compliance Radiology 102

XTalks

SEPTEMBER 14, 2020

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. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.

Vaccine 92

Vaccine Vaccination Antibody Life Science 92