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.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

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.

Licensing 119

Licensing Licensing Vaccination Vaccine 119

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.”

Vaccination 98

Vaccination Vaccine Trials Immune Response 98

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. Global Phase 3 study expected to start in the coming weeks. About the Phase 2 study.

Immune Response 52

Immune Response Vaccination Vaccine Trials 52

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

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Lilly also has studies on the go for LY3127804, an investigational antibody targeting angiopoietin 2 (Ang2).

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Antibody levels against the A strains were higher than the B subtypes.

Vaccination 98

Vaccination Vaccine Immune Response Antibody 98

pharmaphorum

JULY 13, 2022

Bicycle’s bicyclic peptide drug discovery platform is designed to produce drug candidates that have targeting properties like antibodies but are much smaller molecules, making manufacturing and dosing easier. The post Roche rings Bicycle bell again, grabbing another cancer target appeared first on.

Immune Response 105

Immune Response Drugs Antibody Manufacturing 105

The Pharma Data

DECEMBER 11, 2020

The test has been designed to quantitatively measure of immunoglobulin G (IgG) antibodies to aid clinicians in identifying patients with an immune Covid-19 response pre- and post-vaccination. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

Antibody 52

Antibody Vaccination Vaccine Containment 52

pharmaphorum

AUGUST 11, 2021

The decision to move not phase 3 comes after initial results from a phase 1/2 study found that it stimulated neutralising antibodies against SARS-CoV-2 in all 80 recipients, with no safety issues recorded.

Vaccination 98

Vaccination Vaccine Immune Response Protein 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. Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. In CADENZA, the antibody met its combined objective of improving haemoglobin levels in the blood by at least 1.5 Sutimlimab, which Sanofi acquired via its $11.6

Drugs 96

Drugs Immune Response Development Antibody 96

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

SEPTEMBER 4, 2020

The data, published in Nature Medicine, show that the investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by neutralising antibodies and prevented severe clinical disease, including weight loss, pneumonia and mortality, the firm said.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. The company will work with Medsafe, New Zealand’s regulatory agency, to obtain product approvals as needed. and Australia.

Protein 52

Protein Vaccination Vaccine Immune Response 52

The Pharma Data

SEPTEMBER 25, 2020

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. Immune Response Data.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease,” said Landry.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

SEPTEMBER 2, 2020

The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate. Source link.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

pharmaphorum

JANUARY 26, 2021

Other countries, including Australia and Thailand, have also been informed of a reduction in supply of the AZ shot, according to the BBC , which suggests that problems at a plant in Belgium run by one of AZ’s manufacturing partners is at the root of the issue, although other reports point to spoiled batches and problems sourcing some raw materials.

Vaccination 69

Vaccination Vaccine Antibody Immune Response 69

The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. 14, 2020 ). 2 infection. The interim phase 2 results will be published in a peer-reviewed journal, the companies said.

Vaccination 40

Vaccination Vaccine Immune Response RNA 40

The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. government in order to accelerate its development and manufacturing. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine, if approved.

Protein 52

Protein Vaccination Vaccine Immune Response 52

The Pharma Data

AUGUST 6, 2020

It signed a manufacturing and distribution agreement with R-Pharm in Russia and tapped the Serum Institute of India to provide for low-income countries. South Korea’s SK Bioscience recently joined AZ’s COVID-19 vaccine manufacturing network, and Daiichi Sankyo stated in late June that it’s in discussions to supply the shot in Japan.

Vaccination 52

Vaccination Vaccine Antibody Licensing 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

JANUARY 8, 2021

While the manufacturer can submit further evidence following this first draft guidance, there is a chance interim funding could be discontinued if NICE comes to the same conclusions in final draft guidance. Opdivo is a monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with the PD-L1 and PD-L2 proteins.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Protein 52

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. SHANGHAI , Nov. SHANGHAI , Nov.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

pharmaphorum

JANUARY 7, 2021

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

Immune Response 53

Immune Response Doctor Doctors Pharma Companies 53

The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. and Mexico pivotal Phase 3 trial and manufacturing scale-up. . Mexico pivotal Phase 3 trial update.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. ” The vaccine will be manufactured in Stockton-on-Tees.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. GSK is the leading manufacturer of vaccines globally. CHENGDU, China , Feb. For more information, visit www.dynavax.com. About GlaxoSmithKline.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

DECEMBER 23, 2020

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.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

JANUARY 6, 2021

ImaginAb will receive license fees and payments for manufacturing and other support. ImaginAb engineers antibody fragments called minibodies that maintain the exquisite specificity of full-length antibodies while remaining biologically inert in the body. No other terms were disclosed. ImaginAb Inc.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52