Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. Often referred to as a type of gene-modified cell therapy, CAR-T cell therapies involve genetically modifying a patient’s own T cells to produce a protein that enables them to identify and kill cancer cells.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 2, 2024

Alzheimer’s disease is commonly associated with clumps and tangles of proteins building up in brain cells. A study led by researchers from the Stanford University School of Medicine returned to observations of large fat drops […]

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Scienmag

NOVEMBER 12, 2020

Inhaled delivery of a formulation of a key protein involved in the immune response – interferon beta-1a – to hospitalised COVID-19 patients in the UK reduced the odds that they would develop severe disease or die from SARS CoV-2 infection.

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Drug Discovery World

DECEMBER 19, 2023

The first patient has been dosed with an engineered B cell investigational therapy in a Phase I trial in Mucopolysaccharidosis type I (MPS I). The post World’s first engineered B cell therapy enters human trials appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

NOVEMBER 11, 2022

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. These trials comprised the Phase III VAT08 Stage 2 trial analysing initial efficacy and two other immunogenicity 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).

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Drug Discovery World

SEPTEMBER 4, 2023

In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. In this study, researchers discovered how EGCG breaks apart tangles of the protein tau, a ‘hallmark’ of Alzheimer’s disease.

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Roots Analysis

JANUARY 19, 2024

Introduction In a strategic move to accelerate the development and launch of genetic medicines, BridgeBio Pharma has successfully secured up to USD 1.25 ATTR is an inherited disease causing abnormal transthyretin protein and the accumulation of amyloid protein in various tissues, including the heart.

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Drug Discovery World

AUGUST 23, 2022

A Phase I/II clinical trial targeting a treatment for Huntington’s Disease (HD) using a gene therapy has been given the clearance to go ahead in France. . The disease is caused by anomalous repeating mutations in the huntingtin gene leading to abnormal protein aggregates in nerve cells.

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Pharmaceutical Technology

JULY 6, 2022

A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in June this year.

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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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Pharmaceutical Technology

SEPTEMBER 14, 2022

The protein-based vaccine is indicated as a two-dose initial regimen for active immunisation for the prevention of Covid-19 in adults aged 18 years and above. The latest development was based on the totality of manufacturing, preclinical and clinical trial findings filed for assessment.

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Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical will combine their resources and knowledge to develop NurrOn’s ATH-399A and other compounds targeting Nurr1 [nuclear receptor-related 1 protein] to treat neurodegenerative disorders. They will help to progress ATH-399A towards a Phase I trial.

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Pharmaceutical Technology

MAY 11, 2023

It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system. The EC’s approval follows a positive opinion from the committee for medicinal products for human use. Ultomiris met the primary endpoint of time to first on-trial relapse, confirmed by an independent adjudication committee.

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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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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Scienmag

MAY 27, 2021

A digital tool that will make it cheaper, safer and faster to develop new medicines is being rolled out by scientists from the University of Bath in the UK.

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XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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Pharma Mirror

SEPTEMBER 11, 2022

Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

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pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.

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Drug Discovery World

NOVEMBER 11, 2022

Immutep has revealed encouraging initial clinical data from two trials investigating its lead product candidate eftilagimod alpha in non-small-cell lung cancer. . Findings from the trials were shared at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022. . months.” .

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Pharmaceutical Technology

APRIL 28, 2023

Generate Biomedicines has signed a co-development and commercialisation agreement with the University of Texas MD Anderson Cancer Center to expedite the development of new protein therapeutics for oncology using generative AI.

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pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. RECOVERY is conducted by the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine.

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Pharmaceutical Technology

NOVEMBER 13, 2022

The approval was based on the findings from the randomised, multicentre, open-label, international Phase III POSEIDON trial. In the trial, the safety profile of Imjudo plus Imfinzi and chemotherapy combination treatment was in line with each medicine’s known profiles without any new safety signals detected.

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STAT News

NOVEMBER 29, 2022

SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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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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Scienmag

MARCH 15, 2021

The first vaccine has been administered in a comparative adjuvant trial of DNA prime/protein boost HIV vaccine regimens in Kericho, Kenya Credit: U.S. Military HIV Research Program SILVER SPRING, Md.

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Pharma in Brief

NOVEMBER 18, 2020

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. The Trial Judge’s conclusion was consistent with the views of the experts he preferred and the principles in the governing jurisprudence. Trial decision. Appeal decision. Skilled person.

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Pharmaceutical Technology

JANUARY 20, 2023

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

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Pharmaceutical Technology

FEBRUARY 7, 2023

The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines. The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein. It decreases the osteoclast’s production and activity by attaching to and inhibiting RANKL.

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