Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.

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Immune Response In-Vivo Production Manufacturing 246

World of DTC Marketing

DECEMBER 29, 2020

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. First, a novel approach was used that didn’t require traditional vaccine production in cell cultures or eggs. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.

Vaccine 307

Vaccine Vaccination Development Clinical Trials 307

Pharmaceutical Technology

MARCH 31, 2023

Eligibility for the UK’s National Health Services (NHS) booster programmes in England is restricted to those ages 75 years and above or individuals with weakened immune systems. The NHS will be using Covid-19 vaccines manufactured by Pfizer, Moderna and Sanofi.

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Vaccination Vaccine Immune Response Antibody 277

Drug Patent Watch

DECEMBER 9, 2024

These large, complex molecules are made inside living cells, which can lead to small variations in the manufacturing methods that can have a significant impact on the final product.

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Clinical Trials Clinical Trials Immune Response Production 97

The Pharma Data

MAY 17, 2021

The interim results from the phase 2 trial on the vaccine, published today, on the contrary, showed a “ strong neutralizing antibody response” ? The companies also noted a high immune response after a single dose of the shot in patients with prior infection, indicating, they said, strong booster potential for the jab. “

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Immune Response Vaccination Vaccine Antibody 52

Pharmaceutical Technology

AUGUST 15, 2022

MHRA chief executive Dr June Raine said: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 1 variant as well as the original 2020 strain.”.

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Vaccination Vaccine Immune Response Clinical Trials 214

Pharmaceutical Technology

OCTOBER 6, 2022

Intended for intranasal administration, NGoXIM was demonstrated to be effective in animal models and elicited a durable and cross-protective immune response in proof-of-concept (PoC) studies. . Therapyx will develop and manufacture the IL-12-containing microspheres in the vaccine called GneX12.

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Vaccination Vaccine Development Bacterium 147

Pharmaceutical Technology

APRIL 11, 2023

The approval enables the company to manufacture and market azithromycin to treat infections such as bronchitis, pneumonia and sexually transmitted diseases (STDs). Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

XTalks

NOVEMBER 12, 2024

Adjunctive Therapies Using Immune Modulators Immune modulators, which help to regulate the body’s immune response, are increasingly recognized as supportive treatments for pneumonia. These therapies work by controlling excessive inflammatory responses in the lungs.

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Bacteria Life Science Vaccination Vaccine 110

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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Vaccination Vaccine Immune Response Protein 147

pharmaphorum

SEPTEMBER 30, 2020

As expected, patients in the study formed two populations: those who had already mounted an immune response and those whose immune response was not yet adequate. These were identified by the presence (seropositive) or absence (seronegative) of antibodies against the virus, and by high viral loads at baseline.

Antibody 135

Antibody Immune Response Trials Protein 135

pharmaphorum

JULY 5, 2021

The reason none of them can say with certainty whether or not they are truly safe is because everyone’s immune response is unique to that individual. we have found macro, population-wide trends that largely echo those that have been reported by the CDC and vaccine manufacturers themselves. As the U.S. About the author.

Immune Response 105

Immune Response Antibody Vaccination Vaccine 105

pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood. . You’ve had your two COVID-19 jabs, but are you actually protected against infection?

Antibody 137

Antibody Immune Response Vaccination Vaccine 137

pharmaphorum

JUNE 29, 2021

The Com-COV trial compared two shots with Pfizer/BioNTech’s Comirnaty, two doses of AstraZeneca’s Vaxzevria, and a mixed regimen of one of each jab, and found that all were effective at stimulating a “robust” immune response against the coronavirus, according to the investigators.

Immune Response 128

Immune Response Vaccination Vaccine Antibody 128

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Vaccine Vaccination Trials Immune Response 98

Pharmaceutical Technology

DECEMBER 6, 2022

In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

Vaccination 130

Vaccination Vaccine Development Immune Response 130

The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. For media and investors only. Issued: London UK. About the Phase 2 study.

Immune Response 52

Immune Response Vaccination Vaccine Trials 52

pharmaphorum

JANUARY 12, 2021

For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens. There are other theoretical advantages as well.

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Licensing Licensing Vaccine Vaccination 119

pharmaphorum

OCTOBER 5, 2022

Called NGoXIM, the vaccine is based on gonococcal OMVs combined with sustained-release microspheres containing recombinant human IL-12, supplied Intravacc’s US partner Therapyx, which are designed to boost the immune response to the antigens.

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Vaccine Vaccination Immune Response Bacterium 98

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Last year, Merck said due to increasing global demand for TICE BCG, the company could not keep up with manufacturing enough of it.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Last year, Merck said due to increasing global demand for TICE BCG, the company could not keep up with manufacturing enough of it.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 26, 2022

A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) On July 26, 2022, the FDA extended the biologics license for Jynneos to allow for additional manufacturing at one of Bavarian Nordic’s plants.

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Vaccination Vaccine Immune Response Manufacturing 130

XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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Clinical Trials Clinical Trials Vaccine Vaccination 75

Pharmaceutical Technology

FEBRUARY 3, 2023

In Imbokodo, two parts of the immune response seemed to correlate with protection, one of which is the activity of antibodies to the V1 and V2 regions of the envelope protein, says Susan Zolla-Pazner, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City.

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Vaccination Vaccine Antibody Trials 293

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

Immune Response 52

Immune Response Medicine Vaccination Vaccine 52

Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

Development 97

Development Drugs Immune Response Manufacturing 97

pharmaphorum

JULY 18, 2022

It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. We get a higher immune response with the inhaled compared to the injectable,” Morgon relays.

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Vaccine Vaccination Development Immune Response 138

Camargo

DECEMBER 13, 2021

A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development 161

Development Production Immune Response Licensing 161

XTalks

DECEMBER 20, 2021

The EUL from the WHO means that Novavax and its manufacturing partner Serum Institute of India (SII) can begin delivering the vaccine to the COVAX facility program, a global initiative headed by Gavi, the vaccine alliance, as a co-partner, which provides vaccines to low-income countries. Gavi secured 1.1

Vaccine 96

Vaccine Vaccination Protein Manufacturing 96

pharmaphorum

JANUARY 6, 2023

If successful, the partnership may also lead to manufacturing investments in the UK. According to BioNTech, the first patient will be enrolled into a clinical trial of one of its vaccines before the end of the year, with the focus on studies in “adjuvant or metastatic settings.”

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Clinical Trials Clinical Trials Trials Vaccination 111

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility.

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Vaccination Vaccine Clinical Trials Clinical Trials 116

Pharmaceutical Technology

MAY 2, 2023

The most widely utilised IO class is immune checkpoint inhibitors (ICIs), which work by blocking the inhibitory interactions between tumour cells and T-cells, facilitating an anti-tumour immune response. There are more than 20 marketed ICIs with approvals across a very wide spectrum of solid tumour indications.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

pharmaphorum

MAY 11, 2021

The technology is designed to replace antibodies, which have become standard therapy in many diseases but are complicated and expensive to manufacture. ” Laronde plans to hire more than 200 people over the next two years and build what it calls a ‘Gigabase Factory’ for clinical and commercial manufacturing.

RNA 98

RNA Drugs Protein Immune Response 98

The Pharma Data

APRIL 15, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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Immune Response Vaccination Vaccine Clinical Trials 52

STAT News

NOVEMBER 3, 2022

The early-stage study, which is being sponsored by BioNTech, aims to evaluate safety, tolerability, and immunogenicity, or the ability to generate an immune response. The trial is being conducted in the U.S. and the companies aim to enroll 180 volunteers between the ages of 18 and 64.

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Vaccination Vaccine Drug Delivery Systems Sales 97

XTalks

JUNE 24, 2022

In a press announcement outlining the amended authorizations, the FDA said its “evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.”. The vaccine had been authorized for use in individuals five years of age and older.

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Vaccine Vaccination Immune Response Trials 98

XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved.”.

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Vaccine Vaccination Immune Response Trials 105