Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Ongoing efforts.

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The Pharma Data

OCTOBER 26, 2020

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients.

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The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. As part of the arrangement under OWS, representatives from NIAID, BARDA and Moderna are part of the oversight group that receives recommendations from the trial’s independent DSMB. El Sahly, M.D., El Sahly, M.D.,

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Scienmag

SEPTEMBER 25, 2020

A combination antibody treatment for preventing COVID-19 illness in individuals who have had sustained exposure to someone with the virus is being studied by researchers at The University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System’s Lyndon B.

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Drug Discovery World

SEPTEMBER 25, 2023

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. It is an adaptation of an earlier universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing trials.

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Scienmag

SEPTEMBER 15, 2020

A study on the effectiveness of multiple treatments, including laboratory-made antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting is underway by researchers at The University of Texas Health Science Center at Houston (UTHealth). Johnson Hospital.

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Scienmag

AUGUST 11, 2020

Baylor Scott & White Research Institute becomes first site in the world to conduct new trial testing experimental monoclonal antibodies as a treatment for hospitalized COVID-19 patients Credit: Baylor Scott & White Research Institute DALLAS, Texas – On Wednesday, August 5, in Dallas, just one day after the initiative was launched by (..)

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Delveinsight

AUGUST 6, 2020

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. FDA turns back peanut allergy patch of DBV Technologies. The agency raised no safety concerns.

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Drug Discovery World

DECEMBER 6, 2022

While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy shows new promise, according to data from a first-in-human clinical trial. . The Phase I trial (IAVI G001) tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing.

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Pharmaceutical Technology

JUNE 8, 2023

With respect to immunogenicity, neutralising antibody titers against ancestral Spike and variants of concern were boosted by the samRNA candidate, and contrasting to authorised vaccines, persisted through at least 6 months following the booster dose. of these are in the pre-clinical stage.

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Scienmag

MAY 27, 2021

New Penn Medicine study shows how T cells compensate when other immune cells go down PHILADELPHIA–Antibodies aren’t the only immune cells needed to fight off COVID-19 — T cells are equally important and can step up to do the job when antibodies are depleted, suggests a new Penn Medicine study of blood cancer patients with […]. (..)

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Scienmag

MARCH 31, 2021

New findings from a Michigan Medicine study reveal that antibody testing is predictive of prior COVID-19 infection, and rapid screening methods – even from finger pricks – are effective testing tools. Researchers analyzed antibody tests conducted on more than 500 subjects […].

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XTalks

NOVEMBER 30, 2023

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.

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Drug Discovery World

AUGUST 31, 2022

The amount of SARS-CoV-2 antibodies in the blood of patients hospitalised with Covid-19 could be used to predict illness severity and other clinical outcomes. . The study authors suggest that antigen levels could help determine those patients most likely to benefit from therapies directed at fighting the virus. .

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Delveinsight

JANUARY 21, 2021

Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work. These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. billion in total for three drugs.

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Drug Discovery World

MAY 1, 2024

A single injection of an experimental monoclonal antibody called L9LS was 77% effective at preventing malaria infection in children in Mali, according to the results of a mid-stage clinical trial. The antibody was modified with a mutation that prolonged its durability in the bloodstream following administration.

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XTalks

JANUARY 20, 2021

However, IBS patients do not have allergies to any given foods, nor any gastrointestinal conditions, such as celiac disease. Ovalbumin led to increased dietary-antigen-specific IgE antibodies in the mice that were limited to the intestine. Moreover, the response did not induce symptoms typical of a food allergy.

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The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

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The Pharma Data

MAY 22, 2023

These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22. “I’ve MSPH, Associate Professor at the University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial. “I’ve

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XTalks

JANUARY 27, 2021

The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.

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The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.

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Delveinsight

AUGUST 27, 2020

The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults. Freenome secures USD 270 Million to boost its colorectal cancer blood test.

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Scienmag

MAY 13, 2021

New study suggests COVID vaccines may still be helpful for patients with antibody deficiency disorders According to data from a cohort of adult and pediatric patients with antibody deficiencies, patients that often fail to make protective immune responses to infections and vaccinations showed robust T-cell activity and humoral immunity against SARS-CoV-2 (..)

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The Pharma Data

NOVEMBER 25, 2020

FDA’s approval of remdesivir (Veklury) was supported by the agency’s independent, in-depth analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Researchers evaluated the clinical status of subjects on Day 14. The design of ACTT-1 (i.e.,

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The Pharma Data

FEBRUARY 12, 2022

Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today. “As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. About bebtelovimab.

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Drug Discovery World

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I).

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The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Eli Lilly and Company (NYSE: LLY) today announced changes to the purchase agreements with the U.S.

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Bioengineer

JULY 23, 2021

“Given the respiratory tropism of the virus, it seems surprising that only seven of the nearly 100 SARS-CoV-2 vaccines currently in clinical trials are delivered intranasally,” Lund and Randall said. The seventh vaccine candidate is an inert protein subunit.

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The Pharma Data

MARCH 4, 2021

Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year. Dupilumab development program.

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Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

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XTalks

OCTOBER 26, 2023

Some of the vaccines are already in clinical trials, including a universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC), part of the National Institutes of Health (NIH). “A For COVID, it is much the same case.

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The Pharma Data

FEBRUARY 19, 2022

Study A of clinical program evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in 138 patients aged 6 years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. About Dupixent.

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The Pharma Data

FEBRUARY 13, 2022

About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years).

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pharmaphorum

AUGUST 3, 2020

While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations. Staff will also be deployed to minimise the impact of the trial on facilities that don’t normally run clinical trials.

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XTalks

DECEMBER 24, 2020

Most antibody drugs and vaccines have been developed to target parts of the spike protein. These include remdesivir, baricitinib, dexamethasone and three antibody drugs. Antibody drugs were also developed as targeted COVID-19 treatments. Vaccine Considerations.

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Pfizer

JULY 26, 2022

Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA). has a fever.

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