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Gene Gene Therapy Vaccine 
Camargo
JULY 27, 2021
How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. Gene Therapy Definition.
238 
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.
287
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Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The therapy received approval based on positive Phase III trial (NCT02773849) results.
246 
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.
347 
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.
312 
Pharmaceutical Technology
APRIL 19, 2023
The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5
334 
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.
287 
Pharmaceutical Technology
DECEMBER 11, 2022
The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.
289 
Bio Pharma Dive
SEPTEMBER 10, 2020
The contract manufacturer is riding a boom in demand for both its gene therapy and vaccine manufacturing services.
130 
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.
289 
Pharmaceutical Technology
AUGUST 1, 2022
Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates.
289 
XTalks
NOVEMBER 15, 2024
Pfizer released a new respiratory syncytial virus (RSV) vaccine TV commercial, titled “Your Moments Are Worth Protecting: Celebration” as part of its ongoing campaign to raise awareness about the importance of vaccination against RSV. Moderna entered the RSV vaccine arena this year with the very first mRNA-based RSV vaccine.
105 
Pharmaceutical Technology
MARCH 20, 2023
RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The mRNA vaccine candidates will help reduce the chances of autoimmune responses that might lead to allergic conditions or serious autoimmune diseases.
245 
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. The core objective of the collaboration is to make the therapies affordable and accessible to patients.
130 
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.
351 
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.
262 
XTalks
JANUARY 4, 2024
Pfizer has kickstarted the new year with its first-ever gene therapy approval, awarded by Health Canada to the company’s Beqvez (fidanacogene elaparvovec) for the treatment of hemophilia B. There is a significant focus on developing gene therapies as longer-term solutions for the disease.
111 
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.
264 
pharmaphorum
AUGUST 10, 2023
Manufacturing gene therapies, oncolytic viruses, and vaccine candidates: In conversation with ABL Mike.Hammerton Thu, 10/08/2023 - 08:00 Bookmark this
98 
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.
245 
Pharmaceutical Technology
APRIL 6, 2023
Moderna has announced that its cancer vaccine mRNA-4157/V940 along with Keytruda secured the European Medicines Agency (EMA) Priority Medicines (PRIME) scheme designation for the adjuvant treatment of high-risk stage III/IV melanoma patients after complete resection. Topic sponsors are not involved in the creation of editorial content.
245 
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.
105 
pharmaphorum
AUGUST 31, 2022
After a recent approval, there are now three gene therapies available on the US market. In recent years, gene therapy has transitioned from a promising idea to a reality for patients, with many of the severe safety issues that emerged in early iterations of the technology being overcome. from 2021 to 2029.
98 
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.
91 
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
214 
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.
304 
Pharmaceutical Technology
SEPTEMBER 22, 2022
It could be that you are lucky, and there is already a cancer vaccine on the market that you will get priority for. Alternatively, there are vaccines ready to enter decentralised third-phase clinical trials, so you can enrol quickly.
342 
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.
90 
Pharmaceutical Technology
JANUARY 31, 2023
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. vaccine efficacy (VE) against RSV-LRTD, defined by two or more symptoms and 82.4% The findings showed 83.7%
182 
Pharmaceutical Technology
APRIL 20, 2023
Circio aims to develop new circRNA medicines initially for cancer, then plans to expand rapidly into vaccines and gene therapy. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Topic sponsors are not involved in the creation of editorial content.
240 
Pharmaceutical Technology
SEPTEMBER 1, 2022
The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. According to the amended EUA, the vaccines are indicated to be administered at a minimum of two months after the initial or booster dose.
260 
Pharmaceutical Technology
DECEMBER 5, 2022
With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub. With an initial focus on enchaining mRNA technology and developing a vaccine for Chlamydia, the research at the hub is anticipated to commence in the first quarter of next year.
246 
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…
126 
Pharmaceutical Technology
FEBRUARY 3, 2023
With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more.
244 
Pharmaceutical Technology
MARCH 31, 2023
The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
264 
STAT News
AUGUST 12, 2022
… Two children have died from acute liver failure after being administered Zolgensma, a pricey gene therapy sold by Novartis to treat a rare disease , STAT reports. The Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.
98 
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.
147 
Pharmaceutical Technology
JUNE 1, 2023
A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
242 
Pharmaceutical Technology
AUGUST 28, 2022
Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, is said to have infringed patents filed by Moderna between 2010 and 2016 for its mRNA technology. This technology was vital for developing Spikevax, an mRNA Covid-19 vaccine of Moderna. 5 Omicron-targeting bivalent booster vaccine for Covid-19, mRNA-1273.222.
246 
Pharmaceutical Technology
JULY 18, 2022
Moderna has received provisional registration from the Australian Therapeutic Goods Administration (TGA) for its messenger RNA (mRNA) Covid-19 vaccine, Spikevax, for kids aged six months to five years. The 25µg two-dose vaccine regimen is indicated for active immunisation for the prevention of Covid-19.
246 
Pharma Times
JULY 6, 2022
Deal involves the manufacturing of mRNA-based vaccines, therapeutics and gene therapies
123 
BioPharma Reporter
JANUARY 13, 2022
Samsung Biologics flags further facility construction plans, with biologics, cell and gene therapies and next-generation vaccines to be the focus of those new sites.
130 
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.
147 
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.
147
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