pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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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. Novavax’s vaccine is a sequence of protein engineered from the genetic sequence of the SARS-CoV-2 virus that mimics the “Spike” protein found on the pathogen’s surface.

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XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. Casanova’s lab is now searching for the genetic driver behind the autoantibodies.

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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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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. Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.

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pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. COVID-19 Vaccine AstraZeneca , formerly AZD1222.

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The Pharma Data

DECEMBER 30, 2020

The United Kingdom authorized AstraZeneca ’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said. Those concerns have pushed back expected Emergency Use Authorization (EUA) of the AstraZeneca vaccine by two months.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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Drug Discovery World

FEBRUARY 8, 2023

To make meaningful progress on diverse participation in clinical trials, we need meaningful collaboration with regulators, patients, academia, other biopharma companies and the wider healthcare ecosystem so that together we can achieve a shared goal of better health outcomes for all.”

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Clinical Research Research Clinical Trials Clinical Trials 97

pharmaphorum

FEBRUARY 18, 2021

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. In a response statement Pfizer and BioNTech noted that the COVID-19 vaccine did still provide protection in the lab study.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.

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pharmaphorum

JANUARY 13, 2022

BioNTech and artificial intelligence start-up InstaDeep say they have developed an early warning system that can predict high-risk variants of COVID-19 from their genetic sequences much earlier than with current methods. ” The AI also evaluated the newer IHU strain (B.1.640.2)

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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

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Drug Discovery World

JANUARY 11, 2024

The team, led by University College London (UCL), King’s College London and Moderna scientists, found that mRNA could be used to correct a rare genetic liver disease known as argininosuccinic aciduria in a mouse model. We believe it can now do the same for rare diseases.”

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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pharmaphorum

JANUARY 20, 2021

UK biotech ConserV Bioscience has joined with California’s Lawrence Livermore National Laboratory to develop broad-spectrum coronavirus vaccines as concerns mount over potentially more infectious strains emerging in the UK, South Africa and Brazil. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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Vaccination Vaccine Protein RNA 52

The Pharma Data

APRIL 20, 2022

These tests look for signs of genetic abnormalities in a fetus by testing a sample of blood from the pregnant person. We strongly urge patients to discuss the benefits and risks of these tests with a genetic counselor or other health care provider prior to making decisions based on the results of these tests.”.

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Genetics Cosmetics Radiology Production 52

The Pharma Data

NOVEMBER 21, 2021

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth. People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. Source link: [link].

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Drug Discovery World

AUGUST 16, 2023

The whole world realised the power of RNA when the Covid-19 pandemic brought us the first mRNA-based vaccines. This information processing portion of the genome and the RNAs produced by it (the lncRNAs) regulates the ability of our biological processes to interface with the environment and change cellular states.

RNA 52

RNA Genome Genomics DNA 52

Drug Discovery World

SEPTEMBER 14, 2023

Vaccines were up 9.1% Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format. Specialty care grew 11.8% Chris Boshoff, M.D., As a result of these moves, William Pao, M.D.,

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Drugs Vaccination Vaccine Medicine 59

pharmaphorum

JULY 20, 2022

Junk DNA is a term used to describe the 97% of the genetic sequence in human cells found between the 3% coding for our 20,000 genes, once thought to be inert. Recently, studies have suggested large tracts of it have some form of biological function, including the regulation of genes themselves. billion last year.

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DNA Scientist Genome Genomics 116

WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. The currently approved CD-19 CAR products are autologous, ex vivo cellular therapies.

In-Vivo 52

In-Vivo Clinical Trials Clinical Trials FDA Approval 52

pharmaphorum

JANUARY 12, 2022

EMA “lags behind” other international regulators when it comes to approval timelines, finds EFPIA analysis. The EC’s upcoming review of pharmaceutical regulation, part of the EU Pharmaceuticals Strategy, comes as the region faces substantial unmet need in disease areas from cancers to Alzheimer’s, liver disease to CNS disorders.

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Regulation Medicine Marketing Gene Therapy 105

pharmaphorum

AUGUST 8, 2022

The boards of both companies have recommended the deal to shareholders, and the two companies suggested it should close before the end of the year – assuming of course it doesn’t fall foul of any antitrust issues raised by financial regulators. It comes shortly after the group closed a $6.7

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Drug Discovery World

NOVEMBER 27, 2023

In addition, it has stimulated increased collaboration among drug developers, technology providers, supply chain organisations, and regulators. Anis also serves on the scientific and editorial advisory board of Genetic Engineering News , Mary Ann Liebert, Inc.

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Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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Drug Discovery World

MAY 25, 2023

The aim of the researchers is to understand the mechanisms that regulate cancer cell proliferation, survival and dissemination; to identify critical components of these pathways as targets for novel cancer therapies; and to help translate this knowledge to patient benefit.

Research 52

Research Drugs In-Vitro Insulin 52

The Pharma Data

MARCH 7, 2022

The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use. The FDA, an agency within the U.S. Source link: [link].

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Genome Genomics Production Marketing 52

The Pharma Data

JANUARY 17, 2021

–( BUSINESS WIRE )– Genus plc (LSE: GNS), a global biotechnology leader in animal genetics, today reported continued strong performance across its operations for the six-months period ending December 31, 2020. 18, 2021 07:00 UTC. BASINGSTOKE, England & MADISON, Wis.–( and £49.0m

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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. population.

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Immune Response Protein Medicine Genetics 52

pharmaphorum

JUNE 11, 2021

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. By mid-May 2021, seven different COVID vaccines were in use in at least one country, and close to 1.5 billion doses were administered to people worldwide.

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