Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Vaccination Vaccine Gene Therapy Manufacturing 289

Bio Pharma Dive

AUGUST 26, 2020

Catalent, which is already helping the British pharma make its vaccine, will now add key services from a Maryland gene therapy plant.

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Vaccination Vaccine Gene Therapy Manufacturing 273

BioSpace

JUNE 2, 2022

Top research stories, including gene regulation and longevity, a head-to-head comparison of COVID-19 vaccines, a newly discovered type of brain cell and more.

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Regulation Gene Vaccination Vaccine 89

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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Engineer Vaccination Vaccine Clinical Trials 262

BioPharma Reporter

MARCH 25, 2022

Exothera, a CDMO specializing in the industrialization of vaccine and gene therapy processes, reports that it has achieved GMP certification for its facilities in Jumet, Belgium.

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Gene Therapy Gene Vaccination Vaccine 96

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

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Vaccination Vaccine Development RNA 245

Pharmaceutical Technology

JULY 15, 2022

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada.

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Vaccination Vaccine Gene Therapy Antibody 264

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

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Vaccination Vaccine Immune Response Clinical Trials 214

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene Development Antibody 130

Bio Pharma Dive

APRIL 3, 2023

By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.

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Gene Therapy Gene Vaccination Vaccine 343

STAT News

FEBRUARY 22, 2023

Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham. Continue to STAT+ to read the full story…

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Gene Editing Gene Genetic Disease Gene Therapy 126

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. With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country.

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Vaccination Vaccine Gene Therapy Clinical Trials 130

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. By Cytiva Thematic.

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Vaccination Vaccine Development Gene Therapy 147

Pharmaceutical Technology

SEPTEMBER 29, 2022

The mRNA-1273.222 vaccine comprises 25µg doses of mRNA-1273 (Spikevax) and a vaccine candidate against the BA.4/BA.5 Moderna has so far obtained authorisations for Omicron-targeting bivalent booster vaccine in the US, Canada, Europe, Australia, South Korea, Switzerland, Japan, Singapore, Taiwan and the UK.

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Vaccination Vaccine Gene Therapy Clinical Trials 147

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: IgG gene expressing animal models. To obtain human antibody responses within a mouse, mice are genetically engineered to be humanised for their Ig genes.

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Gene Expression Gene Genetic Engineering Antibody 130

Pharmaceutical Technology

MAY 12, 2023

BioNTech has ended its research collaboration with Matinas after its oral mRNA vaccine failed to demonstrate preclinical activity. Whilst BioNTech has shelved its oral mRNA vaccine project, shares were up this week following promising early results of a personalised mRNA vaccine for pancreatic cancer.

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Vaccination Vaccine In-Vivo In-Vitro 130

STAT News

OCTOBER 5, 2022

Scientists rely on gene synthesis technologies as a research tool for everything from basic research to vaccine development and drug target identification. Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes.

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Gene DNA Engineer Scientist 98

Pharmaceutical Technology

OCTOBER 26, 2022

SK bioscience has signed a new collaboration agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA) vaccines for infectious diseases. The company has obtained the newest vaccine platform technologies such as bacterial culture, cell culture and genetic recombination.

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Vaccination Vaccine Development Gene Therapy 130

Bio Pharma Dive

SEPTEMBER 10, 2020

The contract manufacturer is riding a boom in demand for both its gene therapy and vaccine manufacturing services.

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Gene Therapy Gene Contract Manufacturing Manufacturing 130

Pharmaceutical Technology

OCTOBER 18, 2022

Moderna has entered an agreement with Gavi, the Vaccine Alliance, with regard to the delivery of Covid-19 vaccines to lower-income countries supported by the Gavi COVAX Advance Market Commitment (AMC). According to the deal, the parties will cancel pending orders under the existing Covid-19 vaccine supply agreement for this year.

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Vaccination Vaccine Gene Therapy Containment 130

Pharmaceutical Technology

JULY 4, 2022

Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future. Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year.

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Vaccination Vaccine Gene Therapy Manufacturing 147

Medical Xpress

FEBRUARY 3, 2023

A new research perspective was published in Genes & Cancer on January 30, 2023, entitled, "Leveraging a powerful allogeneic dendritic cell line towards neoantigen-based cancer vaccines."

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Vaccination Vaccine Gene Research 90

Pharmaceutical Technology

AUGUST 24, 2022

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. Irrespective of previous infection or age, the vaccine also showed neutralising antibody responses against the BA.4 1 subvariant.

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Vaccination Vaccine Gene Therapy Antibody 130

BioPharma Reporter

MAY 6, 2022

CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.

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Gene Therapy Gene Genetics Production 96

Bio Pharma Dive

JUNE 29, 2022

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.

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Gene Therapy Regulation Gene Vaccination 273

Pharmaceutical Technology

AUGUST 17, 2022

These programmes will include therapies and vaccines in infectious disease and oncology areas. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments. Topic sponsors are not involved in the creation of editorial content.

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RNA Vaccination Vaccine In-Vivo 147

Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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Vaccination Vaccine Gene Therapy Protein 130

pharmaphorum

APRIL 22, 2022

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The post Astellas takes $170m charge as it drops DMD gene therapies appeared first on.

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Gene Therapy Gene DNA Licensing 105

Drug Discovery World

OCTOBER 13, 2023

The scientists say the tool can help inform the development of vaccines and therapies for SARS-CoV-2 and other rapidly mutating viruses. The University has also launched a new global consortium to research and develop next-generation Covid-19 and flu vaccines, backed by £8 ($9.8) million funding from UK Research and Innovation (UKRI).

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Vaccination Vaccine Immune Response Scientist 105

Pharmaceutical Technology

DECEMBER 21, 2022

This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure. Additionally, the centre is anticipated to have to capacity to make up to 250 million doses of vaccines per year.

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Gene Therapy Vaccination Vaccine Manufacturing 351

Bio Pharma Dive

JANUARY 14, 2021

A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.

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Gene Therapy Gene Vaccination Vaccine 300

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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Vaccination Vaccine Gene Sequencing RNA 105

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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Vaccination Vaccine Trials Gene Sequencing 98

BioPharma Reporter

OCTOBER 10, 2023

OrganaBio, a contract technology development and manufacturing organization (CTDMO) specializing in solutions for cell and immunotherapy development, has launched a new division.

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Gene Therapy Clinical Trials Clinical Trials Gene 96

Pharmaceutical Technology

DECEMBER 18, 2022

The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company. 5), mRNA-1273. By Cytiva Thematic.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

BioTech 365

JUNE 28, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: ADA: TB vaccine repurposed in Type 1 diabetes restores gene expression in key immune cells.ADA: TB vaccine repurposed in Type 1 diabetes restores gene expression in key … Continue reading →

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Gene Expression Gene Vaccination Vaccine 40

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. BacTRL Gene Therapy Platform.

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Clinical Trials Clinical Trials Vaccination Vaccine 75