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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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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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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The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

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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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pharmaphorum

MAY 24, 2022

While health authorities are on alert, the WHO said it thinks the outbreak can be contained and that the overall risk to the population remains low. Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19. ” Vaccines and drugs are available.

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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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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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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.”

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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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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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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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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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Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. mRNA contains instructions that direct the cells to make proteins. We believe it can now do the same for rare diseases.”

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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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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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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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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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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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XTalks

OCTOBER 26, 2023

The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.

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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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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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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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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Roots Analysis

MARCH 16, 2023

It is worth noting that several companies have begun to develop mRNA-based cancer immunotherapies and vaccines for infectious diseases. mRNA Therapeutics and Vaccines Delivery Routes Efficient delivery of both therapeutic and vaccine candidates plays a key role in ensuring the effective expression and presentation of antigens.

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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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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.

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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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pharmaphorum

DECEMBER 2, 2020

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying.

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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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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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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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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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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.

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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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