Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

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Pharmaceutical Technology

MARCH 1, 2023

The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. Pfizer /BioNTech and Moderna’s mRNA-based vaccines were the first to receive emergency use authorisation (EUA) out of all other Covid-19 vaccines under development in late 2020.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2022

The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade.

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Pharmaceutical Technology

JUNE 30, 2022

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer.

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Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

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Roots Analysis

NOVEMBER 6, 2023

RNA-based therapeutics have completely revolutionized the healthcare segment, greatly influencing the study and treatment of human diseases by conferring precise targeting ability to therapeutic modalities. The below figure presents the distribution of next generation RNA-based therapeutics and RNA-based vaccines, based on type of molecule.

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Pharmaceutical Technology

JUNE 8, 2023

Gritstone bio has reported interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against Covid-19 (CORAL-BOOST). The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults.

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Pharmaceutical Technology

MARCH 23, 2023

China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19. The independently developed SYS6006 vaccine has been designed to target some major Omicron variants. in clinical trials.

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Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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pharmaphorum

DECEMBER 14, 2022

The mRNA technology that was deployed so effectively in vaccines against COVID-19 has now been found to offer similar promise against cancer, according to Merck & Co and Moderna. The vaccine primes the immune system to attack the tumour cells, while Keytruda blocks an immunological ‘brake’ that protects the cancer.

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Pharmaceutical Technology

NOVEMBER 30, 2022

in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m in milestone payments.

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Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above.

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Drug Discovery World

MAY 18, 2023

A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers at Duke University in Durham, North Carolina. The trial will enrol up to 50 healthy volunteers aged 18 to 49.

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pharmaphorum

AUGUST 16, 2022

Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, consummating a relationship that first started in 2018 and spanned a range of mRNA-based vaccines for infectious diseases. billion, including $150 million upfront.

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BioTech 365

AUGUST 31, 2021

HDT Bio Corp and Gennova Complete Phase 1 Trial of COVID-19 RNA Vaccine in India HDT Bio Corp and Gennova Complete Phase 1 Trial of COVID-19 RNA Vaccine in India Vaccine Would Be India’s First Indigenous RNA Vaccine, Exemplifying HDT … Continue reading →

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BioTech 365

JANUARY 17, 2022

Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine HDT Bio’s RNA-based vaccine offers simpler … Continue reading →

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XTalks

MARCH 21, 2022

Credited as a pioneering RNA interference (RNAi) therapeutics company, Alnylam Pharmaceuticals is taking Pfizer and Moderna to court, claiming that the companies’ use of the lipid nanoparticle (LNP)-based RNA delivery technology in their mRNA COVID-19 vaccines infringes on a patented technology.

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pharmaphorum

OCTOBER 12, 2022

Shares in Moderna were ticking upwards today after Merck & Co took up an option on a personalised RNA-based cancer vaccine with a payment of $250 million. As we all know, cancer vaccines have had a rough history. The post Merck gets on board with Moderna cancer vaccine in $250m deal appeared first on.

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VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

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pharmaphorum

SEPTEMBER 22, 2022

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. Antibodies cover the pathogen of the virus and neutralise it.

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BioTech 365

DECEMBER 13, 2021

HDT Bio Partner Quratis Doses First Healthy Volunteers in Phase 1 Trial of HDT Bio’s RNA COVID-19 Vaccine in South Korea HDT Bio Partner Quratis Doses First Healthy Volunteers in Phase 1 Trial of HDT Bio’s RNA COVID-19 Vaccine in … Continue reading →

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pharmaphorum

NOVEMBER 30, 2021

GlaxoSmithKline has found a replacement for head of vaccines R&D Emmanuel Hanon, who left the company for a US biotech earlier this year, hiring Phil Dormitzer from Pfizer. His most recent role at Pfizer was chief scientific officer for RNA and viral vaccines, a position he held for more than six years. Phil Dormitzer.

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pharmaphorum

SEPTEMBER 16, 2020

In May, Germany pledged to provide up to €750 million ($889 million) in funding to support vaccines against COVID-19, and the main recipients have now been revealed – BioNTech, CureVac and IDT Biologika – which are all German biotechs. Both of these vaccines are based on RNA and in phase 3 and phase 1 testing, respectively.

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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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pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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Drug Discovery World

APRIL 16, 2023

Personalised mRNA-based cancer vaccine mRNA-4157/V940, in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) improved recurrence-free survival (RFS) compared with pembrolizumab alone in patients with high-risk melanoma. According to the results of the primary trial analysis, after 18 months, the RFS was 78.6%

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Scienmag

SEPTEMBER 8, 2021

In December 2020, two novel messenger RNA (mRNA) vaccines for SARS-CoV-2 received emergency use authorization from the U.S. Food and Drug Administration; however, the early trials excluded lactating women, leading to questions about their safety in this specific population.

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pharmaphorum

MAY 11, 2021

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data.

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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. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

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The Pharma Data

DECEMBER 10, 2020

Moderna has begun dosing adolescents in a phase 2/3 trial evaluating messenger RNA-based vaccine candidate mRNA-1273 and plans to enroll 3,000 U.S. participants aged 12 to 17. Source link.

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pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

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pharmaphorum

FEBRUARY 19, 2021

billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. Novavax has signed a deal to provide 1.1

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Drug Discovery World

APRIL 11, 2023

US-based start-up Atomic AI is using artificial intelligence (AI) to design more intelligent RNA-targeted and RNA-based medicines. The technology can also generate synthetic data sets, or make human trials more efficient, by identifying the most suitable patients, predicting outcomes and optimising dosages and regimens of drugs.

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Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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The Pharma Data

DECEMBER 14, 2020

Supported by promising phase 1 data, CureVac announced Monday that it has enrolled the first participant in the pivotal phase 2b/3 study of its messenger-RNA based coronavirus vaccine, CVnCoV. We are hopeful that this trial will continue to demonstrate the impact of mRNA technology,” said CureVac CEO Franz-Werner Haas.

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The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.

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