Delveinsight

AUGUST 27, 2020

Moderna’s COVID-19 vaccine triggers an immune response in older adults. Moderna showed robust phase 1 results for its COVID-19 vaccine in adults up to 55 last month. It is now following up with data from a small group of older adults, and they look positive.

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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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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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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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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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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. . Testing Therapies, Antivirals and Vaccines. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody. Please read more here. .

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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

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.

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 million doses of Moderna’s vaccine candidate against COVID-19 , mRNA-1273. “As

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The Pharma Data

NOVEMBER 17, 2020

Mymetics continues to progress its Covid-19 vaccine development plan based on its virosome-vaccine platform. This new study will complement Mymetics’ other preclinical Covid-19 studies that are ongoing at Baylor College of Medicine in Texas USA and the Helmholtz Center of Infection Research in Germany.

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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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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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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.

FDA Approval 52

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Fri, 07/08/2022 - 11:48.

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Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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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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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

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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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XTalks

DECEMBER 7, 2020

Past Few Weeks Herald Good News on the Vaccine Front. First came the news from Pfizer and its German partner BioNTech that their mRNA vaccine was 90 percent effective in preventing symptomatic COVID-19 disease. In their trial, some 30,000 patients received either two doses of Moderna’s mRNA-1273 vaccine 28 days apart or placebo.

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Vaccination Vaccine Development Drugs 52

XTalks

OCTOBER 26, 2023

The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.

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Pfizer

SEPTEMBER 28, 2022

5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age. 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

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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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Genetics Antibody Trials Medicine 40

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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Medicine Genetics Antibody Allergies 40

Pharmaceutical Technology

JULY 18, 2022

Moderna has received provisional registration from the Australian Therapeutic Goods Administration (TGA) for its messenger RNA (mRNA) Covid-19 vaccine, Spikevax, for kids aged six months to five years. The 25µg two-dose vaccine regimen is indicated for active immunisation for the prevention of Covid-19.

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The Pharma Data

APRIL 4, 2022

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. There are approximately 160,000 patients in the U.S. living with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments. About Dupixent.

Medicine 52

Medicine Trials Allergies FDA Approval 52

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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Pharmaceutical Technology

AUGUST 5, 2022

According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials. According to Mabbott, a challenge with developing mAbs or vaccines is their potential toxicity. That said, if one appears, it should be rigorously examined, he adds.

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Drug Discovery World

FEBRUARY 1, 2023

An experimental vaccine against Marburg virus (MARV) was proved to be safe and induced an immune response in a small, first-in-human clinical trial. No approved vaccines or specific therapies are available for MARV disease, aside from supportive care.

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Vaccination Vaccine Immune Response Clinical Trials 52

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. The candidate demonstrated 64.7%

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Bioengineer

JULY 23, 2021

Intranasal vaccination is needle-free and elicits immunity at the site of infection, the respiratory tract. – There are many reasons that an intranasal vaccine against the SARS-CoV-2 virus would be helpful in the fight against COVID-19 infections, University of Alabama at Birmingham immunologists Fran Lund, Ph.D., Credit: UAB.

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The Pharma Data

JULY 29, 2021

Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity.

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HR Licensing Licensing FDA Approval 52

Pfizer

SEPTEMBER 16, 2022

1 bivalent vaccines. The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

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Pfizer

OCTOBER 19, 2022

In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 5-adapted bivalent COVID-19 vaccine for use in children under 5 years of age. 5-adapted bivalent COVID-19 vaccine across age groups. . AUTHORIZED USE.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Important Safety Information There are limited clinical data available for bamlanivimab.

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The Pharma Data

JUNE 25, 2021

Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Novavax, Inc. Erck, President and Chief Executive Officer, Novavax.

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The Pharma Data

APRIL 11, 2021

Basel, 12 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals.

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pharmaphorum

SEPTEMBER 1, 2021

Johnson & Johnson’s HIV vaccine candidate has failed its first major efficacy test, as it was unable to protect women against infection with the virus in a phase 2b trial carried out in sub-Saharan Africa. Earlier clinical results suggested that Ad26.Mos4.HIV

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