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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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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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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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. But the logistics of delivering the vaccine are hugely challenging, with up to 4 million sent out this month alone.

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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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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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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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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.

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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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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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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. billion COVID shots to global vaccine drive appeared first on.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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The Pharma Data

OCTOBER 25, 2020

German drugmaker CureVac said preclinical studies of its COVID-19 vaccine candidate, CVnCoV, showed the vaccination prompted a successful immune response. The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice.

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pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

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The Pharma Data

JANUARY 11, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. 18, 2020 ). It has already received $2.8

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The Pharma Data

AUGUST 12, 2020

Moderna continues to rise to meet the demands of the pandemic, signing a new deal with the US Government to supply 100 million doses of its messenger RNA (mRNA) vaccine candidate for the prevention of COVID-19. billion in total to the research and delivery of the vaccine candidate under its Operation Warp Speed. Matt Fellows.

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The Pharma Data

MAY 4, 2021

The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. Posted 04 May 2021 | By Kari Oakes .

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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

MAY 3, 2021

The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . Pfizer also shared antibody responses from the younger age group.

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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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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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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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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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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.

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The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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The Pharma Data

DECEMBER 3, 2020

The Pfizer – BioNTech and Moderna ’s COVID-19 vaccines are currently being reviewed for possible Emergency Use Authorization (EUA) by the U.S. On Tuesday, the Pfizer-BioNTech vaccine was granted temporary authorization in the UK and dosing will begin next week. Pfizer gets its raw materials for the vaccine from the U.S.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CureVac.

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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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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The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. vaccination efforts. Andrew Badley, director of the Mayo Clinic’s HIV Immunology Laboratory in Rochester, Minn. WEDNESDAY, Jan.

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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 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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