Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, advances in the study of broadly neutralising antibodies (bNAbs) have led to new candidates being studied in early trials. While the production of bNAbs is a complicated process, vaccines could be designed to prompt the body to induce bNAbs, says Karim.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

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

Worldwide Clinical Trials

JUNE 21, 2024

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

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Antibody Clinical Trials Clinical Trials In-Vitro 162

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV.

Immune Response 52

Immune Response Vaccination Vaccine Antibody 52

Pharmaceutical Technology

MAY 17, 2023

Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic. The treatment is an investigational first-in-class monoclonal anti-human complement factor C5a antibody.

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pharmaphorum

JULY 27, 2022

The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and the Omicron variant that are designed to increase “the magnitude and breadth of the immune response.” Clinical data show strong neutralising antibody responses against Omicron BA.1,

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Protein Immune Response Vaccination Vaccine 122

Scienmag

MAY 26, 2021

In series of samples collected from individuals vaccinated against COVID-19, an ultrasensitive test detected low concentrations of circulating antigen; Following robust production of antibodies, viral protein declined to undetectable levels The carefully orchestrated dance between the immune system and the viral proteins that induce immunity against (..)

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Immune Response Protein Vaccination Vaccine 54

pharmaphorum

JULY 18, 2022

“It is programmed and coded for the production of the full-length spike protein of the coronavirus. 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.

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Pharmaceutical Technology

JANUARY 19, 2023

The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials. Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial.

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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.

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pharmaphorum

JUNE 28, 2022

billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The biotech has the option to share costs and profits for developing and commercialising the three product candidates in the US.

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Pharmaceutical Technology

JUNE 5, 2023

The therapeutic candidate constitutes bacterially-derived nanocells loaded with mitoxantrone coated in bispecific antibodies that recognize oncogenic receptors on the tumor cell surface. It is administered intravenously. The therapeutic candidate acts by targeting EGFR expressing cancer cells. It is developed based on EDV nanocell technology.

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Pharmaceutical Technology

MAY 2, 2023

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Marketed bispecific antibodies are largely bispecific T-cell engagers (BiTEs), which work by directing T-cells to antigen-expressing tumour cells.

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Genetic Engineering Antibody Clinical Trials Clinical Trials 130

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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pharmaphorum

AUGUST 11, 2022

Figures from the UK Office for National Statistics (ONS) have revealed that the number of people with higher levels of COVID-19 antibodies in their blood is declining quickly – leading to calls for booster vaccination campaigns to be started as soon as possible. in March to 71.9% in mid-July. . “We already know the latest Omicron BA.4

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The Pharma Data

DECEMBER 16, 2020

To help determine the minimum antibody levels needed to maintain a safe “return to normal” 20/20 plans to urge its antibody test consumers to complete and update cloud accessible health questionnaires and will deploy machine learning to calculate individualized antibody thresholds based on age, race, BMI and other clinical factors.

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pharmaphorum

JUNE 3, 2021

Genmab has enlisted the help of Bolt Biotherapeutics to develop a new class of immune-boosting antibody conjugates for cancer in a deal that could be worth up to $880 million. “Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients,” he added.

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XTalks

OCTOBER 12, 2021

The vaccine was tested in rats and showed strong, immediate and long-lasting immune responses to confer protection against the disease. is an autoantigen, which means it is an endogenous antigen that triggers an immune response in the body. antibodies in the knockout (KO) rats. With the finding that 14-3-3?

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Vaccination Vaccine Research Immune Response 105

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.

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Pharmaceutical Technology

APRIL 18, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Antibody Vaccination Vaccine In-Vitro 52

pharmaphorum

NOVEMBER 30, 2020

Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.

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Gene Therapy Gene Antibody Clinical Trials 105

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

Antibody 52

Antibody Trials Production Clinical Trials 52

pharmaphorum

DECEMBER 11, 2020

Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults. While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.

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pharmaphorum

FEBRUARY 9, 2022

The oncology segment has been recognised as one of the most productive areas for pharmaceutical companies to focus their R&D investment. While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response. over the last five years.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 20, 2022

Dry powder, inhaled vaccines hold advantages against respiratory diseases because they provide improved protection through a mucosal immune response , as well as being more stable, and are easier to deliver. Serum neutralising antibody increases were noted to be particularly high in subjects who had previously received an mRNA vaccine.

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Vaccination Vaccine Immune Response Antibody 98

The Pharma Data

NOVEMBER 23, 2021

A team of researchers led by the University of Zurich (UZH) has now discovered another component that contributes to SARS-CoV-2 immunity – previous antibody responses to other, harmless coronaviruses. This is when antibody levels against the virus are still very high.

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Immune Response Antibody Vaccination Vaccine 52

Roots Analysis

FEBRUARY 23, 2024

Imagine a world where scientists work together to create special “soldiers” in our bodies called antibodies. Sometimes, scientists ask for help from experts who are really good at finding and designing these antibodies. What are the steps involved in an antibody discovery project? These heroes help to fight diseases.

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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.

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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.

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Immune Response Vaccination Vaccine Clinical Trials 52

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.

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pharmaphorum

APRIL 9, 2021

The cytokine release prompts T-cells so they can translate that first innate immune response into a long-lasting adaptive immune response. The quality of the science led us to really focus on key mechanisms and pathways in innate immunity.”. That’s what is most exciting about all this,” says Mahjoubi.

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Immune Response Development Trials Clinical Trials 122

pharmaphorum

APRIL 14, 2022

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. billion product at peak. Analysts at Jefferies have previously said they think epcoritamab could become a $1.5

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Licensing Licensing Immune Response Antibody 64