Marketing, Radiology and Vaccination - Clinical Research Informer

UTMB and HDT Bio receive US funding for vaccine development

Pharmaceutical Technology

NOVEMBER 30, 2022

in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m in milestone payments.

Vaccination

Vaccination Vaccine Development Gene Therapy

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

Marketing

Marketing Clinical Trials Clinical Trials Radiology

AZD1222 US Phase III primary analysis confirms safety and efficacy

The Pharma Data

MARCH 24, 2021

76% vaccine efficacy against symptomatic COVID-19. 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. 100% efficacy against severe or critical disease and hospitalisation.

Radiology

Radiology Vaccination Vaccine Trials

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

The Pharma Data

MARCH 22, 2021

79% vaccine efficacy at preventing symptomatic COVID-19. 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.

Trials

Trials Vaccination Vaccine Radiology

AstraZeneca’s COVID-19 vaccine; Type 1 diabetes research updates; FDA nod to Zebra’s X-ray modelling AI; UniQure/CSL haemophilia B gene therapy curbs bleeding in phase 3

Delveinsight

DECEMBER 10, 2020

AstraZeneca’s COVID-19 vaccine data suggest single-dose efficacy. The full data from late-phase trials of AstraZeneca’s COVID-19 vaccine have pointed to the potential for AZD1222 to work after a single dose and limit asymptomatic cases; however, missed main questions regarding the efficacy of the candidate.

Gene Therapy

Gene Therapy Gene Vaccination Vaccine

Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

MAY 3, 2021

Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ). US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ). Next Generation of Covid-19 Vaccines Could Be Pill or Spray ( WSJ ). In Focus: US. In Focus: International.

Gene Therapy

Gene Therapy Vaccination Vaccine Bioequivalency

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , PLYMOUTH MEETING, Pa. , mg and 2.0

DNA

DNA Vaccination Vaccine Immune Response

FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. , .

Marketing

Marketing Production Radiology Cosmetics

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody

Antibody In-Vivo Medicine Vaccination

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody

Antibody In-Vivo Vaccination Vaccine

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. 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. The price of that prize is incalculable.

Vaccination

Vaccination Vaccine Antibody Life Science

Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy

Delveinsight

SEPTEMBER 2, 2021

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

Marketing

Marketing Radiology Drugs Drug Delivery

FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. The FDA, an agency within the U.S.

Genetics

Genetics Cosmetics Radiology Production

What will the 2023 drug discovery landscape look like?

Drug Discovery World

JANUARY 24, 2023

The overall virtual clinical trials market is currently valued at $7.8 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. So where to start?

Clinical Trials

Clinical Trials Clinical Trials Drugs Trials

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We Analogous testing handed by Philips Respironics to the FDA on bias authorized for marketing in theU.S. which failed one safety test for the release of certain chemicals of concern, called unpredictable organic composites (VOCs). had demonstrated respectable results.

Compliance

Compliance Cosmetics Production Manufacturing

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

APRIL 7, 2023

The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations.(5) 39 sites).

FDA Approval

FDA Approval Drugs Medicine Genetics

MS PORTFOLIO DEMONSTRATE POSITIVE IMPACT OF TREATMENT ON PEOPLE LIVING WITH RELAPSING MULTIPLE SCLEROSIS

The Pharma Data

APRIL 17, 2021

Biogen currently has more than 25 MS clinical trials underway including research on considerations around COVID-19 vaccination for people with MS. No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS – P15.210.

Clinical Trials

Clinical Trials Clinical Trials Trials Radiology

Clinical Research Informer

UTMB and HDT Bio receive US funding for vaccine development

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

Trending Sources

AZD1222 US Phase III primary analysis confirms safety and efficacy

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

AstraZeneca’s COVID-19 vaccine; Type 1 diabetes research updates; FDA nod to Zebra’s X-ray modelling AI; UniQure/CSL haemophilia B gene therapy curbs bleeding in phase 3

Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

COVID-19 Pandemic Coverage

Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy

FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

What will the 2023 drug discovery landscape look like?

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

MS PORTFOLIO DEMONSTRATE POSITIVE IMPACT OF TREATMENT ON PEOPLE LIVING WITH RELAPSING MULTIPLE SCLEROSIS

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