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

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

FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

In-Vitro 69

In-Vitro Regulation Production Development 69

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

XTalks

JULY 13, 2022

The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing: A urine collection cup. Some factors that can increase the risk of CKD include diabetes, hypertension, cardiovascular disease, smoking, obesity and a family history of kidney disease. Healthy.io Healthy.io

Reagent 98

Reagent In-Vitro Radiology Life Science 98

FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.

Regulation 59

Regulation Radiology Cosmetics Compliance 59

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 Vaccination 52

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. Criterion 1. Criterion 2.

Development 105

Development Regulation Cosmetics Life Science 105

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

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

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 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

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

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 Vaccination 52

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.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92