The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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Protein Vaccination Vaccine Immune Response 52

The Pharma Data

JANUARY 10, 2021

11, 2021 (GLOBE NEWSWIRE) — Editas Medicine, Inc. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing. CAMBRIDGE, Mass.,

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Medicine Development Clinical Trials Clinical Trials 52

Drug Discovery World

MAY 17, 2024

Cancer trials are notorious because they are dependent on the genetic profile of patients and hence highly-selective. The researchers delved into the genetic makeup of tumours, recognising that genetic mutations heavily influence how tumours respond to drugs. The next challenge is related to the enrollment rates.

Trials 59

Trials Clinical Trials Clinical Trials Protein 59

XTalks

JANUARY 3, 2024

Polydefkis, professor of Neurology at Johns Hopkins University School of Medicine and an investigator in the Phase III NEURO-TTRansform study on which Wainua’s FDA approval was grounded on, in the news release. The accumulation of TTR fibrils disrupts the usual functions of these tissues.

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FDA Approval Protein RNA Clinical Trials 105

pharmaphorum

OCTOBER 2, 2020

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Regulation Vaccination Vaccine Protein 105

The Pharma Data

DECEMBER 3, 2020

Dravet syndrome is a severe and progressive genetic epilepsy characterized by frequent, prolonged and refractory seizures that usually begin within the first year of life. Our goal is to develop a medicine that goes beyond seizure control to address many of the other comorbidities associated with Dravet syndrome.

Medicine 52

Medicine Genetics Clinical Trials Clinical Trials 52

XTalks

DECEMBER 20, 2021

Covovax is a recombinant protein-based vaccine and can be regarded as a more “traditional” vaccine as it isn’t genetic-based like mRNA or viral vector vaccines. Covovax is a protein subunit vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). Gavi secured 1.1

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XTalks

DECEMBER 13, 2023

These efforts encompass programs related to the shingles vaccine, Tdap vaccine and plague vaccine, reinforcing Dynavax’s commitment to advancing the field of vaccines and medicine. The year 2022 has proven to be a momentous period for Fulgent Genetics, marked by significant expansion of its product portfolio across various medical conditions.

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Genetics Vaccination Vaccine DNA 111

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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Vaccination Vaccine Trials Protein 104

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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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 31, 2020

Researchers at Stanford Medicine found that COVID-19 antibodies preferentially target different parts of the SARS-CoV-2 virus in mild COVID-19 cases than they do in severe cases. People with severe COVID-19 have low proportions of antibodies that target the spike protein. The brain’s gray matter contains microglia and astrocytes.

Antibody 52

Antibody Research Bacteria Genetics 52

The Pharma Data

NOVEMBER 10, 2021

In recent times, much scientific trouble and backing has concentrated on developing medicines that target an enzyme with the cumbrous name of Src homology 2- containing protein tyrosine phosphatase 2 or further briefly, Shp2. But Shp2 has also been shown to promote the growth and survival of numerous types of cancers.

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Drugs Protein Medicine RNA 52

The Pharma Data

JULY 28, 2021

The analysis was conducted using AstraZeneca’s global safety database, which captures all spontaneously reported adverse events from real-world use of its medicines and vaccines worldwide. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Vaccination Vaccine Medicine Protein 52

The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). THOUSAND OAKS, Calif.

Medicine 52

Medicine Production Sales Clinical Trials 52

The Pharma Data

MAY 27, 2022

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

Drug Discovery World

NOVEMBER 15, 2022

The libraries contain only the sequences that occur in the human repertoire, rather than randomly generated sequences,” adds Dr Leproust. . They contain all the necessary enzymes for transcription and translation, making it possible to execute the central dogma outside a cell. .

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DNA Drugs Antibody Engineer 98

XTalks

AUGUST 6, 2020

Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant. CBD is the most abundant non-psychoactive cannabinoid compound found in the cannabis plant, making up about 40 percent of the plant’s extract, which contains over 100 different cannabinoid compounds.

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FDA Approval Protein Containment Genetic Disease 64

The Pharma Data

JULY 28, 2021

The results are in line with recent reports in the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Report, the UK system for collecting and monitoring information on safety concerns, which also show low rates of TTS after a second dose. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Vaccination 52

Vaccination Vaccine Protein Medicine 52

The Pharma Data

JANUARY 11, 2021

Neither of the two vaccines approved in the United States — made by Pfizer-BioNTech and Moderna — contains the live virus. They give the body a blueprint to create a bit of the virus that causes COVID-19, called a spike protein. This protein then appears on the surface of the cell and the immune system responds to it.

Vaccination 52

Vaccination Vaccine Allergies Protein 52

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

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Production Gene Protein Vaccination 52

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

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.

Gene Editing 52

Gene Editing Gene In-Vivo Genome 52

The Pharma Data

MARCH 18, 2021

Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Vaccination Vaccine Regulation Protein 52

XTalks

MARCH 10, 2023

Susan Perlman, a clinical professor in the Department of Neurology at the David Geffen School of Medicine, UCLA, in a press release. In the EU, Skyclarys has been granted the Orphan Drug designation and is under review by the European Medicines Agency (EMA). What is Friedreich’s Ataxia?

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 9, 2020

Charlie told pharmaphorum how his search for a genetic cause has led him to straddle the divide between scientist and patient advocate. He is currently the patient advocacy and engagement lead at Congenica, a digital health company that is investigating the genetic basis of rare diseases. For some people, a job is more than just a job.

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Genome Genomics Genetics Genome Project 102

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Manufacturing Hormones Contamination Containment 40

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

MARCH 10, 2021

The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise a genetically engineered version of SARS-CoV-2 with the P.1 The latest research is published in the New England Journal of Medicine. 1 mutations, as well as variants from the UK and South Africa.

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Vaccination Vaccine Genetic Engineering Engineer 66

The Pharma Data

MARCH 14, 2021

The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

SEPTEMBER 5, 2022

Genome interpretation: To decipher genetic variants in cancer . The success of targeted therapies in cancer comes on the heels of identifying specific molecular targets resulting from genetic variations. When selecting patients for therapy, we currently look at variants that directly affect protein expression or function.

Development 52

Development Drugs Protein Genome 52

The Pharma Data

SEPTEMBER 22, 2020

All patients deserve a gene therapy designed to address the genetic root cause of their disease with a single dose. About Spinal Muscular Atrophy SMA is the leading genetic cause of infant death. Zolgensma is approved in the US, Japan and, most recently, Brazil, for patients with SMA under the age of two.

Clinical Development 52

Clinical Development Gene Therapy Development Gene 52

Drug Discovery World

DECEMBER 14, 2023

The new centre represents a flagship investment within the University’s Glasgow Riverside Innovation District (GRID) and will be home to commercial businesses as well as the University of Glasgow-led Living Laboratory for Precision Medicine.

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Drugs Life Science Research Scientist 75

XTalks

SEPTEMBER 8, 2020

Our experience in drug product fill/finish will enable timely manufacturing to make the vaccine available as soon as possible to advance bringing life-changing medicines to market.”. The genetic material contains SARS-CoV-2 spike protein. The Phase 3 trial is being implemented as part of Operation Warp Speed.

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Manufacturing Vaccination Vaccine Allergies 83

XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. protein-based biologics) : are those which bind to specific components (i.e. A growing area in the immunotherapy space is the development of biological modulators, which are genetically engineered proteins that target specific components of the immune system.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Drug Discovery World

AUGUST 10, 2022

To overcome this evasion tactic, the CAR protein was developed to recognise other markers on cancer cells. CAR is a fusion protein composed of an extracellular antibody fragment that recognises antigens and an intracellular domain that directs the T cell to the tumour. Identifying the right CAR T cell target.

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Manufacturing Gene Genome Genomics 98

The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52