Scienmag

JUNE 27, 2021

The first human trial has shown no obvious side effects and a good immune response. Hiroshi Kiyono, CC BY 4.0 A new vaccine to protect against deadly cholera has been made by grinding up genetically modified grains of rice. Researchers based […].

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Vaccination Vaccine Immune Response Trials 72

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Vaccination Vaccine Trials Immune Response 59

Scienmag

DECEMBER 9, 2020

Phase 2 trials in 1,200 adults, young children, and infants suggest new poliovirus vaccine may have the potential to overcome outbreaks caused by a mutated polio strain linked to the oral vaccine that typically circulates in areas of low immunisation coverage, and poses one of biggest barriers to eradication.

Immune Response 75

Immune Response Vaccination Vaccine Scientist 75

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

XTalks

AUGUST 13, 2020

and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. Related: Pfizer and BioNTech’s COVID-19 Vaccine Shows Positive Early Trial Results.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. The post NIH starts trial of Moderna’s mRNA Nipah virus vaccine appeared first on.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

SEPTEMBER 1, 2020

AstraZeneca has started a Phase 3 trial of its experimental coronavirus vaccines in the US, making it the third company to start late-stage trials of a vaccine. . The trial will see participants receive either two doses of the vaccine or a placebo. Photo by Daniel Paquet from Regina, Canada. Conor Kavanagh. Source link.

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Vaccination Vaccine Trials Immune Response 52

XTalks

NOVEMBER 30, 2023

Global entities such as the WHO, the Global Fund and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have developed comprehensive strategies aligned with Sustainable Development Goal (SDG) target 3.3, These findings signify a significant step forward in the development of AGT103-T as a potential gene therapy for HIV.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

Delveinsight

AUGUST 27, 2020

Moderna’s COVID-19 vaccine triggers an immune response in older adults. 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.

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Vaccination Vaccine Research Trials 53

pharmaphorum

SEPTEMBER 29, 2022

The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. The suffering he notes from the #itch is 100… [link]. — Brian S.

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Drugs Immune Response Allergies Sales 69

Pharmaceutical Technology

JUNE 16, 2023

The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials. The aim of the latest ongoing trial is to evaluate the vaccine in a larger and more diverse population.

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The Pharma Data

SEPTEMBER 8, 2021

The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.

Trials 52

Trials Immune Response Allergies Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

OCTOBER 26, 2020

Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. Days after the U.S. The approval marks the first drug approved by the U.S.

Antibody 52

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The Pharma Data

JANUARY 17, 2021

The NDA was built on data from the Phase III VICTORIA trial. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). HFrEF was formerly known as systolic heart failure.

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Manufacturing Immune Response Allergies Drugs 52

XTalks

MAY 2, 2024

Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. Karuna also has ongoing long-term extension trials.

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Drugs FDA Approval Sales Vaccination 52

Delveinsight

JANUARY 21, 2021

These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. chief operating officer of Loxo Oncology, said that CD3-engaging bispecific antibodies are soon becoming one of the most transformative immune-modulating modalities used for cancer treatment.

Research 52

Research Protein Clinical Trials Clinical Trials 52

Bioengineer

JULY 15, 2021

. “We’re excited–with such low doses of radiation, we didn’t expect the response to be so positive,” said lead author Ravi Patel, M.D., “In clinical trials, we tend to go with the maximum tolerable dose, the idea being that radiation kills the cancer and the more we give, the better. ” ###.

Medicine 52

Medicine Clinical Trials Clinical Trials Scientist 52

The Pharma Data

NOVEMBER 17, 2020

Mymetics continues to progress its Covid-19 vaccine development plan based on its virosome-vaccine platform. Since April 2020, Mymetics’ goal is to develop a safe and highly effective virosome-based Covid-19 vaccine that can be easily administered to all age groups, particularly to immune compromised and elderly populations.

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Vaccination Vaccine Containment Immune Response 40

The Pharma Data

APRIL 28, 2021

PARIS – April 23, 2021 – New analyses from Dupixent ® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Head of Global Development in Immunology and Inflammation at Sanofi. “

Dermatology 40

Dermatology Trials Clinical Trials Clinical Trials 40

pharmaphorum

AUGUST 13, 2020

One Pfizer brand getting plenty of attention is Xeljanz, their blockbuster anti-JAK rheumatoid arthritis pill that could damp down the massive immune response that overwhelms some COVID-19 patients. They’re also investing heavily in trials of the best candidates. AbbVie has donated $1.5

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Branding Vaccination Vaccine Filler 105

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. IMPORTANT SAFETY INFORMATION . has a fever.

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Vaccination Vaccine Protein Immune Response 111

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. Plans are in place to conduct further trials of the cAd3-Marburg vaccine in Ghana, Kenya, Uganda, and the United States. Credit: NIAID.

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Vaccination Vaccine Immune Response Clinical Trials 52

The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Global Head, Janssen Research & Development, Johnson & Johnson. “In

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

NOVEMBER 8, 2021

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The new result suggests that REGEN-COV could be used much more broadly than at present. That was down from almost $2.6

Antibody 105

Antibody Vaccination Vaccine Immune Response 105

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Reese , M.D.,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. , Reese , M.D.,

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Trials Production Sales Manufacturing 40

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. President of Research and Development, Novavax. All cases observed in the vaccine group were mild as defined by the trial protocol. Novavax expects to share further details of the PREVENT-19 trial results as additional data become available.

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Vaccination Vaccine Trials Immune Response 40

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

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Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system.

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Vaccination Vaccine Medicine Clinical Trials 100

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. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Scienmag

FEBRUARY 19, 2021

Preclinical tests at UAB last year showed potent systemic and mucosal immune responses in mice after a single intranasal dose. The vaccine candidate was developed by Maryland-based Altimmune Inc. Credit: UAB BIRMINGHAM, Ala. – The Altimmune Inc.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JULY 8, 2021

Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. executive vice president of Research and Development at Amgen. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8) Reese, M.D.,

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Allergies Trials In-Vivo Medicine 52

Drug Discovery World

AUGUST 1, 2023

In terms of partnerships and development , Orbit Discovery and start-up SanegeneBio have entered into a Master Service Agreement to identify tissue-specific delivery of a wide range of RNA therapeutics, as reported by DDW in January 2023. Over at UK biotech firm SynaptixBio, a company which secured £13.2

RNA 52

RNA Drugs Gene Silencing Vaccination 52

The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. These reactions can be treated, and most patients with allergies can still get the vaccine. The partial piece of the spike protein cannot cause COVID-19 disease.

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Vaccination Vaccine FDA Approval Hormones 52

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Aubagio ® sales decreased 1.1% In the U.S.,

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Sales Vaccination Vaccine Medicine 52