Pharmaceutical Technology

DECEMBER 16, 2022

In a recent paper in Nature Medicine by Mackensen and colleagues, a CD19 CAR-T cell therapy was successfully used to treat five patients with refractory SLE. The example of rituximab, originally a cancer drug, now used for lupus, has shown the potential of adopting cancer medications for lupus.

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Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Flow cytometry (FCM) is the primary method scientists use to monitor immune responses in clinical trials, primarily because of its power, speed, and ability to provide a comprehensive view of a disease’s macro-environment.

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Scienmag

JANUARY 26, 2022

WHAT: In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The […]. (..)

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Vaccination Vaccine Immune Response Trials 84

Scienmag

NOVEMBER 18, 2020

Older adults are at a disproportionate risk of severe COVID-19 disease, so it is essential that any vaccine adopted for use against SARS-CoV-2 is effective in this group Peer-reviewed / Randomised Controlled Trial / People **There will be a UK Science Media Centre briefing at 10.15am UK time on Thursday 19th November about this study. […].

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Immune Response Vaccination Vaccine Trials 74

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

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Vaccination Vaccine Immune Response Antibody 119

pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

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Vaccination Vaccine Protein Immune Response 130

Pharmaceutical Technology

MAY 10, 2023

XinThera’s therapy targeting MK2 is expected to enter clinical trials later in 2023. The acquisition will give Gilead Sciences access to XinThera’s portfolio of two small molecule inhibitor programmes, one of which targets PARP1 to treat cancer and the other of which targets MK2 for inflammatory diseases.

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Immune Response DNA Clinical Trials Clinical Trials 130

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. “In Induction of innate immunity was investigated via specific cytokine markers.

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Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. THN391 binds the inflammation-driving component of fibrin, known for activating the immune responses in neurodegenerative and ophthalmologic diseases.

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Development Immune Response Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

JUNE 21, 2024

Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

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.

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Immune Response Vaccination Vaccine Scientist 75

NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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Immune Response Vaccination Vaccine Antibody 62

Scienmag

NOVEMBER 17, 2020

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged 18-59 years recruited in China between 16 April and 5 May 2020 Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged (..)

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. has a fever.

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pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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Vaccination Vaccine Development Immune Response 138

Scienmag

MARCH 24, 2021

Department of Defense When clinical trials were conducted to determine the immunogenicity — the ability to elicit an immune response — for the first two vaccines marshaled against SARS-CoV-2the virus that causes COVID-19, one group was not among those included: people who have received solid organ […].

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Immune Response Vaccination Vaccine Antibody 78

XTalks

DECEMBER 29, 2023

Tarlatamab is an investigational drug currently undergoing clinical trials to assess its efficacy in patients with two distinct types of neuroendocrine cancer: SCLC and neuroendocrine prostate cancer (NEPC). Results demonstrated significant antitumor activity, durable objective responses and encouraging survival rates in these patients.

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Clinical Trials Clinical Trials FDA Approval Trials 119

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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pharmaphorum

NOVEMBER 14, 2022

The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

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Sales Immune Response Drugs Medicine 118

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. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Development Production Immune Response Licensing 161

pharmaphorum

OCTOBER 5, 2022

The disease – commonly known as the clap – was diagnosed in 82 million people in 2020 according to World Health organisation (WHO) estimates and ranks high among the agency’s infectious diseases of greatest concerns as it is rapidly becoming resistant to antimicrobial medicines.

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XTalks

FEBRUARY 19, 2024

In a recent study published by Weill Cornell Medicine in the Journal of Infectious Diseases , researchers have reported the potential of Moderna’s experimental mRNA vaccine in protecting adults against CMV, which could potentially also stop the transmission of the virus from mothers to their infants during pregnancy.

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Vaccination Vaccine Trials Clinical Trials 59

Cloudbyz

JULY 31, 2024

The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics. This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care.

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Gene Therapy Gene Medicine In-Vitro 52

pharmaphorum

MARCH 11, 2021

That is an approach that has been tried in other groups, but so far efforts have been impeded by difficulties in producing enough cells of sufficient quality and protecting them from the patient’s immune response. That implantable technology was at the heart of the Semma acquisition.

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Gene Editing Insulin Immune Response Gene 98

XTalks

NOVEMBER 10, 2020

Update (November 10, 2020): Pfizer and BioNTech announced in a press release yesterday that their candidate COVID-19 vaccine was found to be more than 90 percent effective in preventing infection by the novel coronavirus in Phase III trials. The ongoing Phase III trial continues to evaluate the mRNA vaccine in close to 44,000 individuals.

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Vaccination Vaccine Trials Clinical Trials 75

Scienmag

OCTOBER 15, 2020

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate was carried out in China between 29 April and 30 July 2020 and involved more than 600 healthy volunteers.

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Immune Response Vaccination Vaccine Clinical Trials 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Vaccination Vaccine Trials Clinical Trials 59

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

pharmaphorum

MARCH 4, 2021

Sunak pledged £28 million towards the UK’s capacity for vaccine testing, support for clinical trials and to improve the ability to acquire samples of new COVID-19 variants. The ongoing fight against COVID-19 was a top-line feature of the budget announcement, with an extra £1.65bn to ensure the vaccination roll-out continues to be a success.

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Vaccination Vaccine Development Life Science 105

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

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Immune Response Vaccination Vaccine Clinical Trials 52

Scienmag

JUNE 8, 2021

The study will explore the immune response to COVID-19-specific vaccines in Brazilian healthcare workers to find biomarkers that indicate whether someone will be protected from – or remains […].

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Vaccination Vaccine Immune Response Trials 52

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. as a potential trigger for rheumatoid arthritis.

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Vaccination Vaccine Research Immune Response 105

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 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. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. The Novavax jab is only the second to enter large scale trials in the UK; the other has been developed by the University of Oxford.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About Translate Bio.

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