Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Vaccination Vaccine Immune Response Antibody 277

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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Vaccination Vaccine Immune Response Clinical Trials 214

pharmaphorum

OCTOBER 12, 2022

Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”. The evolving field of genomic medicine. There are two components to genomic medicine, known as the payload and the vector. Forging an AI-enabled path toward precision medicine.

Genomics 105

Genomics Genome Medicine Development 105

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

Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. 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

Worldwide Clinical Trials

MARCH 12, 2024

Deviations from established baseline values provide insights into treatment response in certain cancer indications. These markers can inform treatment response and help reduce patient radiation exposure by reducing the need for repeated imaging assessments in clinical trials.

Clinical Trials 182

Clinical Trials Clinical Trials Immune Response Trials 182

XTalks

DECEMBER 12, 2023

Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. When people think about innovation drivers in global healthcare, they often think of “big pharma,” and not necessarily companies in the plasma medicines space.

Medicine 111

Medicine Recombinant Antibody Protein Antibody 111

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.

Development 130

Development Immune Response 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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Immune Response Vaccination Vaccine Antibody 52

Scienmag

JANUARY 14, 2021

14, 2021) – Researchers at Baylor College of Medicine have discovered how therapeutics targeting RNA splicing can activate antiviral immune pathways in triple negative breast cancers (TNBC) to trigger tumor cell death and signal the body’s immune response. HOUSTON – (Jan.

Immune Response 41

Immune Response RNA Medicine Research 41

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

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.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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). As a bispecific T-cell engager immunotherapy, tarlatamab directs the patient’s T cells to attack cancer cells exhibiting DLL3.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

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

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

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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Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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Immune Response Medicine Vaccination Vaccine 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

APRIL 12, 2021

The adenosine pathway has emerged as an attractive target for immuno-oncology R&D because it is thought to reduce the activity of misfunctioning regulatory T-cells that inhibit the immune response against cancers.

Trials 127

Trials Clinical Trials Clinical Trials Immune Response 127

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

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

DECEMBER 1, 2022

The GCC Vaccine is being analysed in Phase II clinical trials. It can induce immune responses against Guanylyl Cyclase C (GCC) expressing colorectal, pancreatic, gastric and oesophageal cancers. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 130

Gene Therapy Clinical Trials Clinical Trials Immune Response 130

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.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

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.

Development 161

Development Production Immune Response Licensing 161

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. Elizabeth Hart, chief of DCEPT’s General Medicine Branch 1.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

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.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

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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Immune Response Vaccination Vaccine Trials 70

pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, The inhalant version.

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Vaccination Vaccine Development Immune Response 138

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.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 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 guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

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Vaccination Vaccine Development Life Science 105

pharmaphorum

SEPTEMBER 24, 2020

The UK is already leading research into potential therapies and vaccines for the virus – unfortunately as one of the worst-hit countries there have been enough patients available to run large-scale national clinical trials.

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Vaccination Vaccine Trials Immune Response 98

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

Delveinsight

AUGUST 26, 2021

The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. Now, Real Chemistry and Datavant are getting real with a plethora of data that the pair contemplates can help deliver on new gene therapies and precision medicines.

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Vaccination Vaccine Gene Therapy RNA 98

The Pharma Data

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. And safety outcomes were similar in the REGN-COV2 dose groups and the placebo group. Source link.

Antibody 52

Antibody Immune Response Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 7, 2020

In an early-stage clinical trial with 65 volunteers in the United States, an experimental vaccine triggered strong immune responses to a wide range of flu virus strains and subtypes. The immune responses lasted at least 18 months, according to the researchers at Mount Sinai Health System, in New York City. .

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Vaccination Vaccine Scientist Immune Response 52