XTalks

OCTOBER 8, 2024

In a statement , the Nobel Assembly said the laureates discovered a new class of non-coding RNA molecules that play a crucial role in gene regulation. A gene contains instructions within our DNA. Their ability to modulate gene expression at the RNA level provides a novel therapeutic approach for conditions.

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pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

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Pharmaceutical Technology

MAY 2, 2023

4/5 Covid-19 messenger RNA (mRNA) vaccines. The expanded EUAs state that these current bivalent vaccines are now to be used for all primary and booster doses administered to individuals ages six months of age and older. 1 vaccines by both companies were revoked by the FDA in August 2022, after the BA.5

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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Vaccination Vaccine Clinical Trials Clinical Trials 85

Roots Analysis

AUGUST 16, 2023

The success of COVID-19 vaccines paved the path for mRNA-based drug products. Given such technical and operational challenges associated with the production of RNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the contract manufacturing service providers to cater to the urgent global demand.

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Contract Manufacturing Manufacturing Marketing RNA 52

The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. Under Operation Warp Speed, the U.S.

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Vaccination Vaccine Licensing Licensing 52

Roots Analysis

AUGUST 23, 2024

Vaccinations in the past have always been either weak or inactive forms of a pathogen which was given to the body so that our immune system is trained to recognize that given pathogen. There are several advantages to approaching vaccination this way. This alone makes them much safer than most conventional vaccines on the market today.

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XTalks

OCTOBER 21, 2020

The answer may lie in the genetic code of the virus, which scientists at Duke University have found contains several silent mutations that affect protein folding. Moreover, Berrio says the changes likely affected the folding and function of viral RNA. We’ll need to be able to recognize it and make efforts to contain it early.”.

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RNA Protein Genomics Genome 90

The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We

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Vaccination Vaccine RNA Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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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. Disclaimer.

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Manufacturing Vaccine Vaccination Production 52

The Pharma Data

OCTOBER 25, 2020

We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. About Moderna.

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Vaccine Vaccination Manufacturing Clinical Development 52

The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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Vaccination Vaccine Containment Development 52

The Pharma Data

AUGUST 16, 2021

The antiviral agent incorporates RNA-like building blocks into the RNA genome of the virus. If this genetic material is further replicated, defective RNA copies are produced and the pathogen can no longer spread. At full stretch, researchers are developing various vaccines and drugs – with different degrees of success.

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RNA Drugs Genomics Genome 52

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc.,

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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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Vaccination Vaccine Production Manufacturing 52

Roots Analysis

FEBRUARY 13, 2023

Presently, more than 195 mRNA therapeutics / mRNA vaccines are under development or commercialized for the treatment of a variety of indications. In addition to this, more than 95 mRNA synthesis kits, that contain reagents for the synthesis of research grade mRNAs, are currently available in the market.

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Manufacturing Drug Delivery Systems Genetic Engineering RNA 52

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias has extensive experience with analytical method development and testing for mRNA-based vaccines as well as monograph testing of excipients and APIs according to Ph Eur or USP. Assays to support mRNA-based Covid-19 vaccines. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.

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The Pharma Data

OCTOBER 28, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., About Moderna. Forward-Looking Statements.

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The Pharma Data

JANUARY 6, 2021

Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. “The need for vaccines against COVID-19 is enormous. “We are highly committed to making our capabilities and networks available to help end this pandemic.”

Vaccine 52

Vaccine Vaccination Development Production 52

pharmaphorum

NOVEMBER 16, 2022

The study of GSK3036656 – an inhibitor of the bacterial enzyme leucyl t-RNA synthetase (LeuRS) – showed that 14 days’ treatment with a low once-daily dose showed it was able to kill Mycobacterium tuberculosis in patients with drug-susceptible pulmonary tuberculosis , with no serious adverse effects. An estimated 10.6

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Trials RNA Drugs Containment 98

The Pharma Data

NOVEMBER 16, 2020

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The majority of adverse events were mild or moderate in severity.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

XTalks

DECEMBER 13, 2023

Related: Top 30 Pharma Companies in 2023: Statistics and Trends 1) Moderna Compound annual growth rate: 415 percent Moderna, headquartered in Massachusetts, is a prominent biotechnology company specializing in RNA therapeutics, particularly mRNA vaccines. vaccine, mRNA-1273.815.

Genetics 107

Genetics Vaccine Vaccination DNA 107

Pharmaceutical Technology

OCTOBER 28, 2022

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. For example, the Covid-19 pandemic brought messenger ribonucleic acid (mRNA) vaccines into international prominence.

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Bioequivalency Production Contamination Branding 130

XTalks

DECEMBER 1, 2021

Moreover, it is also not known how the current COVID-19 vaccines and drugs will hold up against Omicron. While most of the current COVID-19 PCR tests involve detection of spike RNA, Cue’s test does not and, instead, is based on identifying RNA encoding the virus’s nucleocapsid proteins.

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Gene Genomics Genome Genetics 104

pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022.

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Roots Analysis

AUGUST 15, 2023

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

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Protein In-Vitro Production Reagent 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

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Engineer Genetics Clinical Research Research 52

XTalks

AUGUST 18, 2020

Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. This is significant because shortages of RNA extraction kits have been a recurrent issue since the beginning of the pandemic.

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FDA Approval Reagent RNA Genome 71

Roots Analysis

SEPTEMBER 9, 2024

The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines , is driving advancements in protein expression technology to ensure efficient and scalable production. This process initially involves transcription of DNA to messenger RNA (mRNA). The mRNA is then translated into to form functional proteins.

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Protein Gene Production DNA 40

Pfizer

DECEMBER 13, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Research Vaccines.

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Drugs Licensing Licensing Production 110

Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world. COVID-19, Vaccines. 07.19.2022.

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Drugs Vaccine Vaccination In-Vitro 99

The Pharma Data

JANUARY 10, 2021

Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. China’s Sinovac Biotech reported that its COVID-19 vaccine, CoronaVac, had a 78% efficacy rate in a Phase III clinical trial in Brazil. The drug is an RNA interference (RNAi) therapeutic. Here’s a look.

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Gene Therapy Trials Gene Clinical Trials 52

XTalks

FEBRUARY 11, 2021

Amidst growing global shortages of COVID-19 vaccine supplies, inaugural (by way of authorizations/approvals) COVID-19 vaccine maker Pfizer is addressing the issue by working to cut the manufacturing time of its vaccine by almost half. Related: Pharma Rivals Step Up to Assist with COVID-19 Vaccine Production.

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Manufacturing Vaccination Vaccine DNA 52

The Pharma Data

DECEMBER 8, 2020

Curexsys is founded by Herbert Stadler, a serial biotech entrepreneur, and Jens Gruber, a former group leader of Medical RNA Biology who is going to lead Curexsys as Chief Scientific Officer. They contain proteins, nucleic acids and metabolites, which carry information from secreting to receiving cells.

Manufacturing 52

Manufacturing Containment Life Science Production 52

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.

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Vaccination Vaccine Antibody Protein 162