pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

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pharmaphorum

FEBRUARY 18, 2021

Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing scientists so much concern.

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The Pharma Data

MARCH 13, 2022

People who gained immunity – either through vaccination or exposure – against the original strain of SARS-CoV-2, the virus that causes COVID-19, also are likely to have some protection against the pathogen’s omicron variant. The samples were stored after the researchers measured the T cell response. population.

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The Pharma Data

SEPTEMBER 14, 2020

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness. Source link.

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Advarra

JANUARY 11, 2024

As researchers continue to identify better cellular targets and expand and improve upon immunotherapy approaches, they become better able to predict patient response and better able to learn from cancer cells’ attack strategies. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

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pharmaphorum

SEPTEMBER 8, 2021

Kadmon claimed approval for Rezurock (belumosudil) in July as a treatment for chronic graft versus host disease (GVHD) – a common and often fatal complication that can follow a bone marrow transplant and which occurs when the donated cells mount an immune response against the transplant recipient’s tissues and organs.

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Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

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Drug Discovery World

JULY 5, 2023

Decades of research on the cellular and molecular mechanisms of how the immune system detects and kills cancerous or pre-cancerous cells, known as immune surveillance, and the factors which modulate that response, have led to understanding how we can enable a patient’s own immune system to fight cancer more efficiently in different ways.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Delveinsight

SEPTEMBER 23, 2021

858’s drug candidates include proteins, which regulate RNA and immune response. With the purchase, Novartis will back its adeno-associated virus gene therapy-based options for different forms of genetically related blindness. The financial terms of the deal were not revealed.

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STAT News

MARCH 6, 2023

But they said the sum covers only the direct costs of designing and manufacturing the vaccines ― which are tailored to the unique genetic makeup of each patient’s tumor ― and that the FDA has approved the breakdown of expenses. ” Leaders of the foundation, based in Chapel Hill, N.C.,

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Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials.

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The Pharma Data

MARCH 25, 2021

Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. 4,5 Efficacy varied by serotype.

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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Duchenne Muscular Dystrophy. Prevalence: 1 in 3,500. Lipodystrophy. Prevalence: 1 in 10 million.

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The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

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The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. ” Arnon Rosenthal, Ph.D.,

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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. There are around 300 million people worldwide living with a rare disease.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

The Pharma Data

OCTOBER 22, 2020

The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened and opened by the WHO Deputy Director-General on 14 October 2020 with committee members attending via video conference, supported by the WHO Secretariat.

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Drug Discovery World

DECEMBER 15, 2022

Gene editing tools such as zinc finger nucleases, transcription activator-like effector nucleases (TALEN) and clustered regularly interspaced short palindromic repeat (CRISPR) nucleases have been heralded for their enormous potential to treat diseases and genetic disorders. Likewise, Lessard et al.

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The Pharma Data

JANUARY 21, 2021

Therefore, it’s not likely that a mutation would be able to evade the complex immune response created by a vaccine, even if the mutation makes the spike protein more effective at infecting unvaccinated people, the experts said. “That process is done so efficiently by the [U.S. . ” © 2021 HealthDay.

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Drug Discovery World

MAY 11, 2023

Another dangerous consequence can occur when the therapeutic or vaccine introduces proteins that can activate an uncontrolled immune response. In the case of therapeutics, the aim is usually to avoid patients’ immune responses. Impurities can integrate into the final product at various points during production.

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The Pharma Data

SEPTEMBER 8, 2020

Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

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Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. A healthy immune system is naturally primed to eliminate malignant and abnormal cells through a synchronised and dynamic interplay between adaptive and innate immunity.

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Drug Discovery World

NOVEMBER 3, 2022

They also do not have the potential of causing a severe immune response if they are administered to the wrong patient. The number of therapy classes in development has exploded as research has advanced methods for tackling a vast array of genetic conditions and diseases in both rare disease and common indications.

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The Pharma Data

SEPTEMBER 8, 2020

Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. A further list and descriptions of these risks, uncertainties and other factors can be found in. the United States.

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Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. The primary target indications for tRNA therapeutics include genetic and oncological disorders. In addition, they offer enhanced therapeutic and safety profiles as compared to traditional treatment approaches.

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pharmaphorum

FEBRUARY 28, 2021

Prior to that, the agency’s reviewer said the regulator was satisfied with data showing the shot was 66% effective at preventing COVID-19 28 days after a single dose. The vaccine causes the body to create its own copies of the protein, stimulating an immune response.

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Pharma Marketing Network

JANUARY 20, 2021

In other areas of the industry (such as cell and genetic medicine development) progress continued at an impressively brisk pace despite the pandemic. When the patient is referred, a large historical data set (including biomarker and genetic data) will be available to the provider.

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Drug Discovery World

AUGUST 1, 2023

They are a promising approach for the treatment of genetic drivers of disease.” AstraZeneca’s non-alcoholic steatohepatitis (or ‘NASH’) study is a prime example of the value of ASOs 2. Though some genetic mutations are harmful, others can be protective.

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Delveinsight

SEPTEMBER 8, 2021

The exact cause of SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition, and many studies have revealed a complex genetic basis. The risk factors for SLE include the medicines that induce lupus, age, race/ethnicity, and family history. The severity of lupus flares ranges from moderate to severe.

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The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

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The Pharma Data

DECEMBER 21, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

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The Pharma Data

MAY 13, 2021

Preliminary data obtained through genetic sequencing suggest that the new outbreak was caused by the same virus strain also responsible for the 2014-2016 outbreak and was likely reintroduced by a survivor. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.

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Pharmaceutical Technology

APRIL 24, 2023

In an email to this news service, João Conde, PhD, professor at NOVA Medical School, Universidade NOVA de Lisboa, said advances like the mRNA vaccines serve as a testament to the breakthroughs made by science over decades of research at the junction of genetics and nanomedicine. These could feature in the next four to five years.

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XTalks

SEPTEMBER 14, 2020

It was recently reported that the addition of an adjuvant to their vaccine led to enhanced immune responses that exceeded responses in convalescent serum from symptomatic COVID-19 patients. Several laboratories have already shown that they can detect genetic material from the virus in wastewater.

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