Pharmaceutical Technology

APRIL 10, 2023

It will also be used for the treatment of people who are not likely to have an adequate immune response to Covid-19 vaccination or for people who are not recommended for Covid-19 vaccination. Evusheld (formerly AZD7442) is a combination of two long-acting antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).

Immune Response 264

Immune Response Antibody Vaccine Vaccination 264

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

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company. 5), mRNA-1273.

Gene Therapy 304

Gene Therapy Vaccine Vaccination Clinical Trials 304

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

Vaccine 52

Vaccine Vaccination Protein Antibody 52

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy.

Antibody 52

Antibody Vaccine Vaccination In-Vitro 52

pharmaphorum

APRIL 27, 2022

Vir Biotechnology-partnered COVID-19 antibody Xevudy (sotrovimab) was the big contributor to the improved result, adding £1.3 Turnover of the antibody is likely to fall sharply however as the drug has lower efficacy against the prevailing Omicron BA.2 billion ($1.6 billion) to the company’s top-line of £9.8

Sales 95

Sales Antibody Vaccine Vaccination 95

pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

Antibody 78

Antibody Hormones Medicine Licensing 78

Drug Discovery World

FEBRUARY 23, 2023

Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP). 5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines.

Vaccine 52

Vaccine Vaccination Immune Response Antibody 52

pharmaphorum

OCTOBER 12, 2022

David Del Bourgo (CEO and co-founder, Whitelab Genomics) has always been passionate about introducing disruptive, innovative technologies to markets. We thought, there has to be something to help use data to make [drug developers] more efficient in bringing therapies to market faster, and at a lower price,” Del Bourgo explains.

Genome 104

Genome Genomics Medicine Development 104

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use. 45 years ago.

FDA Approval 98

FDA Approval Medicine Vaccine Vaccination 98

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

Regulation 105

Regulation Vaccine Vaccination Protein 105

pharmaphorum

JULY 19, 2021

A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK. A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route.

Life Science 52

Life Science Medicine RNA Vaccine 52

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Medicine Vaccine 52

pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

Vaccine 96

Vaccine Vaccination Medicine Manufacturing 96

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 filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

Vaccine 73

Vaccine Vaccination RNA Clinical Trials 73

Pharmaceutical Technology

NOVEMBER 7, 2022

5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg vaccine is indicated for usage as a booster shot for active immunisation against Covid-19. Additionally, 28 days following inoculation, this vaccine showed enhanced neutralising antibody responses against Omicron BA.4/BA.5

Vaccine 130

Vaccine Vaccination Gene Therapy Clinical Trials 130

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Vaccine Vaccination 52

Drug Discovery World

OCTOBER 5, 2023

This free 2-hour Summit will take place online and will outline areas of advancement and opportunity in the cancer research market. Find out the answer to questions such as: Where is the opportunity in the cancer research market? What are the best research tools to aid development of new treatments and vaccines?

Research 52

Research Antibody Medicine RNA 52

Drug Discovery World

NOVEMBER 20, 2023

Raquel Sanches-Kuiper , Vice President of Science and Applications at Evonetix, and Clare Whitewoods , Marketing Communications Manager at Evonetix, look at the benefits synthetic DNA brings to pharmaceutical development. The Covid-19 pandemic demonstrated the potential for mRNA vaccines.

DNA 69

DNA Engineer Antibody Gene 69

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. . The companies look forward to working closely with the U.S.

Vaccine 52

Vaccine Vaccination Antibody Packaging 52

Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market. Capacity Analysis.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Vaccine 52

pharmaphorum

AUGUST 15, 2022

The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna’s mRNA-1273.214 shot. 5 found that it stimulated a greater than five-fold increase in neutralising antibodies against Omicron BA.4 1 subvariant. 1 subvariant.

Vaccine 111

Vaccine Vaccination Antibody Regulation 111

The Pharma Data

NOVEMBER 26, 2020

26, 2020 /PRNewswire/ — BASE10 Genetics and DNA Link today announced their collaboration on a research project to evaluate the usability of DNA Link ‘ s AccuFind COVID-19 IgG antibody test in a healthcare setting. Study will expand access to antibody testing outside of laboratory settings. CHICAGO , Nov.

DNA 52

DNA Antibody Research Genome 52

Pfizer

FEBRUARY 9, 2023

Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program kimkevin Thu, 02/09/2023 - 15:05 Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program Friday, February 10, 2023 - 06:45am Share Phase 1/2 trial will enroll up to 900 healthy U.S.

Vaccine 75

Vaccine Vaccination Containment Clinical Trials 75

The Pharma Data

OCTOBER 6, 2021

Pfizer and BioNTech today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18?years

Vaccine 52

Vaccine Vaccination Antibody Medicine 52

pharmaphorum

OCTOBER 30, 2020

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. billion in deposits for the shot.

Vaccine 91

Vaccine Vaccination Sales Trials 91

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccine Vaccination Packaging 130

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

JUNE 24, 2021

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

Vaccine 52

Vaccine Vaccination Trials Medicine 52

Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

Drug Discovery World

OCTOBER 26, 2023

The free two-hour summit will outline areas of opportunity in the oncology market and will feature insights from thought leaders in cancer research, precision medicine and immunotherapy. What you will learn: The latest research strategies to support the acceleration of oncology antibody drugs to market.

Research 52

Research Antibody Vaccine Vaccination 52

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

Pharmaceutical Technology

MARCH 27, 2023

National Resilience will use the funding to establish a significant domestic biomanufacturing capacity and capabilities for vaccines, nucleic acids including mRNA, and biologics including antibodies, proteins and multi-specifics. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 130

Gene Therapy Manufacturing Vaccine Vaccination 130

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

Antibody 52

Antibody Vaccine Vaccination Trials 52

The Pharma Data

AUGUST 21, 2020

As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. Roche and Regeneron join forces to increase global supply of an antibody cocktail for Covid-19.

Vaccine 52

Vaccine Vaccination Manufacturing Contamination 52