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.

Engineer 262

Engineer Vaccine Vaccination Clinical Trials 262

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.

Vaccine 264

Vaccine Vaccination Gene Therapy Antibody 264

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.

Vaccine 245

Vaccine Vaccination Development Allergies 245

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.

Vaccine 245

Vaccine Vaccination Development RNA 245

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.

Gene Therapy 343

Gene Therapy Gene Vaccination Vaccine 343

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.

Gene Therapy 300

Gene Therapy Gene Vaccine Vaccination 300

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

Vaccine 214

Vaccine Vaccination Immune Response Clinical Trials 214

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.

Vaccination 245

Vaccination Vaccine Gene Therapy Medicine 245

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.

Gene Therapy 351

Gene Therapy Vaccine Vaccination Manufacturing 351

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.

Gene Therapy 273

Gene Therapy Gene Regulation Vaccination 273

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%

Vaccine 182

Vaccine Vaccination Gene Therapy Gene 182

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.

Gene Therapy 304

Gene Therapy Vaccine Vaccination Clinical Trials 304

Bio Pharma Dive

SEPTEMBER 10, 2020

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

Gene Therapy 130

Gene Therapy Gene Contract Manufacturing Manufacturing 130

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

Gene Therapy 98

Gene Therapy Manufacturing Gene Vaccine 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.

Vaccine 147

Vaccine Vaccination 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.

Vaccine 147

Vaccine Vaccination Gene Therapy Clinical Trials 147

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.

Vaccination 260

Vaccination Vaccine Gene Therapy RNA 260

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.

Gene Therapy 91

Gene Therapy Gene Vaccine Vaccination 91

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.

Genomics 342

Genomics Genome Clinical Trials Clinical Trials 342

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.

Vaccine 147

Vaccine Vaccination Gene Therapy Manufacturing 147

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccine 162

Vaccine Vaccination Antibody Development 162

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.

RNA 147

RNA Vaccine Vaccination In-Vivo 147

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.

Vaccine 130

Vaccine Vaccination Gene Therapy Clinical Trials 130

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.

Vaccine 246

Vaccine Vaccination Gene Therapy Antibody 246

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.

Vaccine 130

Vaccine Vaccination Gene Therapy Containment 130

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.

Gene Therapy 130

Gene Therapy Gene Development Antibody 130

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.

Vaccine 130

Vaccine Vaccination Development Gene Therapy 130

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.

Vaccine 246

Vaccine Vaccination Gene Therapy Marketing 246

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.

Vaccine 130

Vaccine Vaccination Gene Therapy Antibody 130

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.

Vaccine 130

Vaccine Vaccination Gene Therapy Protein 130

Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. billion in Covid-19 vaccine sales.

Manufacturing 246

Manufacturing Vaccine Vaccination Gene Therapy 246

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.

Research 246

Research Gene Therapy Vaccination Vaccine 246

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.

Vaccination 130

Vaccination Vaccine In-Vivo In-Vitro 130

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.

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

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.

Gene Therapy 105

Gene Therapy Gene DNA Development 105

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.

Gene Therapy 90

Gene Therapy Gene Genetics Vaccination 90

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.

Drug Delivery 242

Drug Delivery RNA Development Drugs 242