XTalks

JANUARY 15, 2021

Ortho Clinical Diagnostics received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VITROS SARS-CoV-2 antigen test for detection of active COVID-19 infection. Related: COVID-19 Vaccine and Drug Development Coverage. active virus).

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In-Vitro Vaccination Vaccine Drugs 105

Scienmag

JANUARY 25, 2022

Vaccination against COVID-19 did not affect fertility outcomes in patients undergoing in-vitro fertilization (IVF), a new study has found. The findings, which were published in Obstetrics & Gynecology (the Green Journal), add to the growing body of evidence providing reassurance that COVID-19 vaccination does not affect fertility.

Vaccination 57

Vaccination Vaccine In-Vitro Medicine 57

Scienmag

DECEMBER 11, 2021

Published today, one of the earliest, peer-reviewed studies looking into the Omicron variant of COVID-19 suggests that people previously infected with COVID, and those vaccinated, will have some, “stronger than basic” defence against this new strain of concern.

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In-Vitro Vaccination Vaccine Research 58

Pharmaceutical Technology

JUNE 1, 2023

The vaccine is self-administered through an intranasal spray, and is based on the company’s GlycoTarge platform. In April 2020, Pneumagen announced positive anti-viral activity results from three in vitro studies into preventing coronavirus infections, but the program has not yet been studied in humans. million ($4.75

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In-Vitro Engineer Protein Vaccine 130

Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.

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Manufacturing Vaccine Vaccination RNA 130

Pharmaceutical Technology

MAY 24, 2023

Morphogenesis’s technologies include Immune Fx (IFx) personalised cancer vaccines and tumour microenvironment (TME) modulators. Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0, Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0, The company is also advancing its mRNA vaccine, IFx-Hu3.0,

Gene Therapy 130

Gene Therapy In-Vivo In-Vitro Immune Response 130

pharmaphorum

JANUARY 22, 2021

So far, neither variant seems to be associated with more severe COVID-19 symptoms, although there has been some preliminary research suggesting the SA strain could allow reinfection with SARS-CoV-2, and also be less susceptible to vaccines. The UK strain – known as B.1.1.7

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In-Vitro RNA Licensing Licensing 141

XTalks

APRIL 27, 2022

In the US, the vaccination for the virus is currently provided to individuals five years of age and older. The in vitro studies showed that remdesivir was effective among the drugs because it had the strongest antiviral activity as it could block virus infection at low micromolar concentrations with minimal cell toxicity.

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FDA Approval In-Vitro Clinical Trials Clinical Trials 98

Camargo

NOVEMBER 29, 2021

Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. Biologics include a wide range of products , including: Vaccines. Definition of Biologic Products. Allergenics.

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Development Protein Production Hormones 180

Roots Analysis

MARCH 16, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is worth noting that several companies have begun to develop mRNA-based cancer immunotherapies and vaccines for infectious diseases.

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Vaccination Vaccine DNA Protein 52

Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. In addition, to meet U.S.

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Research Vaccine Vaccination Drugs 112

The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants.

Protein 52

Protein Vaccination Vaccine Antibody 52

pharmaphorum

DECEMBER 16, 2020

Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says. Strength in the second wave.

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Vaccination Vaccine Life Science In-Vitro 122

Pharmaceutical Technology

SEPTEMBER 10, 2008

Secondly, we conduct pre-clinical research and development in the fields of oncology, cardiovascular disorders, anti-influenza vaccines and diabetology. IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

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In-Vitro Genotoxicity In-Vivo Development 100

pharmaphorum

JANUARY 17, 2023

Research into mRNA dates back to the 1970s, but with the approval of both Moderna and BioNTech/Pfizer’s vaccines, this approach has finally been validated. At the end of last year, the UK government entered into a partnership with the company, which saw Moderna agree to provide 250 million vaccine doses per year over the course of a decade.

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Vaccination Vaccine In-Vivo In-Vitro 97

The Pharma Data

SEPTEMBER 17, 2020

This is the focus of vaccines in development and convalescent plasma therapy. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As The test targets antibodies against the spike protein. Food and Drug Administration (FDA). said Thomas Schinecker, CEO Roche Diagnostics.

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.

Manufacturing 108

Manufacturing Clinical Trials Clinical Trials In-Vitro 108

XTalks

JUNE 27, 2022

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. As such, the smallpox vaccine can be used to protect against monkeypox — according to the WHO, the vaccine is 85 percent effective against monkeypox infection.

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Development In-Vitro Reagent Vaccine 83

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

pharmaphorum

NOVEMBER 4, 2020

However, in vitro or binding-based efficacy insight needs to be confirmed by reliable clinical evidence, as shown by the outcomes of COVID-19 trials with remdesivir and hydroxychloroquine. million worldwide and continues to increase despite the global public health measures that have been put in place.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccine 105

The Pharma Data

MAY 17, 2021

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests. . Posted 17 May 2021 | By Michael Mezher .

In-Vitro 52

In-Vitro Manufacturing Vaccination Vaccine 52

Scienmag

SEPTEMBER 18, 2020

Antibody-like proteins that capture and neutralize SARS-CoV-2 Scientists have used a new high-speed, in vitro selection method to isolate 9 antibody-like proteins (ALPs) that bind to the SARS-CoV-2 virus – 4 of which also exhibited neutralizing activity – within 4 days, according to a new study.

Protein 53

Protein Antibody In-Vitro Scientist 53

XTalks

SEPTEMBER 30, 2020

The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University. The findings reveal a critical role for IFNs in fighting COVID-19 infection, positioning them to be a potential therapeutic target in the disease. percent of women and 12.5

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Antibody Genetics Research In-Vitro 135

pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. Harness technology.

Development 98

Development In-Vitro Manufacturing Compliance 98

Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world.

Drugs 99

Drugs Vaccine Vaccination In-Vitro 99

The Pharma Data

JANUARY 11, 2021

Testing Therapies, Antivirals and Vaccines. By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . One of the open questions about the various vaccines against COVID-19 has been how long the protection offered will last. Diagnostics.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 23, 2021

The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor , has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.

In-Vitro 52

In-Vitro Vaccination Vaccine Trials 52

Pharmaceutical Technology

AUGUST 26, 2008

It was once derided as the stuff of science fiction, but in recent years, biotechnology has emerged as an important growth area in pharmaceuticals. As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines.

Antibody 100

Antibody Licensing Licensing Production 100

Delveinsight

FEBRUARY 23, 2021

The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases. The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

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Drugs Licensing Licensing Production 110

XTalks

DECEMBER 11, 2023

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Let’s examine the list of the top ten fastest growing medical device companies in 2023, ranked by their compound annual growth rate (CAGR). In 2021, Axonics achieved an impressive revenue of $180.3

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Production Sales In-Vitro Development 110

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

Protein 52

Protein In-Vitro Production Reagent 52

XTalks

DECEMBER 19, 2023

1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81 Why it did so well: The COVID-19 pandemic was one of the major drivers for Comirnaty sales in the US in 2022 as it remained the vaccine of choice throughout the pandemic. The rise of the Omicron variant fuelled the sale of the vaccine. billion in sales in 2022.

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Sales FDA Approval Drugs Vaccine 64

The Pharma Data

MARCH 26, 2021

New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. About the VIR-7831 Clinical Development Programme.

Antibody 52

Antibody Trials Vaccination Vaccine 52

The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

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Trials Antibody Vaccination Vaccine 52

The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look. Urovant Sciences’ Vibegron for Overactive Bladder. The drug is a once-daily, beta-3 adrenergic agonist.

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In-Vitro FDA Approval Drugs Manufacturing 52