XTalks

DECEMBER 20, 2021

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.

Vaccination 96

Vaccination Vaccine Manufacturing Protein 96

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 Vaccination Vaccine Protein 105

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. Good news for everyone the Oxford vaccine trials are back up and running. We will back our scientists to deliver an effective vaccine as soon as safely possible [link].

Vaccination 104

Vaccination Vaccine Trials Protein 104

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

Development 101

Development Vaccination Vaccine Production 101

The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

pharmaphorum

AUGUST 23, 2021

The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

DNA 98

DNA Vaccination Vaccine Genetic Engineering 98

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 Vaccination Vaccine Packaging 130

The Pharma Data

DECEMBER 16, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax’ candidate vaccine against COVID-19. GAITHERSBURG, Md.,

Protein 52

Protein Vaccination Vaccine Immune Response 52

XTalks

JULY 1, 2021

Moderna has won approval from the European Medicines Association (EMA) for branding its COVID-19 vaccine with the name Spikevax. Now the vaccine maker is awaiting the same approval from the US Food and Drug Administration (FDA). Pfizer’s Comirnaty was the first COVID-19 vaccine brand name created by the company.

Branding 98

Branding Vaccination Vaccine Clinical Trials 98

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. OspA is a surface protein expressed by the bacteria when present in a tick.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

The Pharma Data

APRIL 22, 2023

The current COVID-19 vaccines are designed to trigger an antibody response to the SARS-CoV-2 spike protein, which is vulnerable to mutations that could make the vaccine less effective over time. of the mice that were vaccinated with the T-cell-based vaccine survived, while only one of the control-group mice survived.

Vaccination 40

Vaccination Vaccine Protein Antibody 40

pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

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. Related: Red Meat Allergy Test Gets FDA Clearance. “We

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

XTalks

NOVEMBER 23, 2020

Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 97

XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

Manufacturing 83

Manufacturing Vaccination Vaccine Allergies 83

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.

Vaccination 75

Vaccination Vaccine Clinical Trials Clinical Trials 75

Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

Manufacturing 147

Manufacturing Production Containment Antibody 147

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.

Vaccination 69

Vaccination Vaccine Trials Immune Response 69

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.

Vaccination 52

Vaccination Vaccine Trials Protein 52

XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. Diamyd Medical is a clinical-stage biopharmaceutical company that develops therapies for type 1 diabetes.

Vaccination 103

Vaccination Vaccine Insulin Trials 103

XTalks

JANUARY 27, 2021

COVID-19 vaccine maker Moderna announced this week that results from a study show that the shot is effective against some of the new circulating variants of SARS-CoV-2. In a news release from Moderna, the company reported that the administration of its COVID-19 vaccine induced antibody titers against both variants.

Vaccination 52

Vaccination Vaccine In-Vitro Protein 52

Roots Analysis

AUGUST 15, 2023

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

Protein 52

Protein In-Vitro Production Reagent 52

pharmaphorum

MAY 6, 2021

UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months. . ” The post New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy appeared first on. Rory McGoldrick.

Development 111

Development Research Containment Protein 111

The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September. Conor Kavanagh.

Vaccination 52

Vaccination Vaccine Trials Containment 52

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Integrated analytical services for pharmaceuticals.

Development 130

Development Manufacturing Production Vaccination 130

The Pharma Data

JANUARY 24, 2021

(NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110.

Development 52

Development Vaccination Vaccine Production 52

The Pharma Data

DECEMBER 30, 2020

The United Kingdom authorized AstraZeneca ’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said. Those concerns have pushed back expected Emergency Use Authorization (EUA) of the AstraZeneca vaccine by two months.

Vaccination 52

Vaccination Vaccine Trials Development 52

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.”. .–( BUSINESS WIRE )– Moderna, Inc.,

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

AUGUST 15, 2023

Exploiting this vulnerability and disrupting the membrane is a promising mechanism of action for developing new antivirals,” said Kent Kirshenbaum, Professor of Chemistry at New York University (NYU) and the study’s senior author. There is an urgent need for antiviral agents that act in new ways to inactivate viruses,” said Kirshenbaum.

Protein 52

Protein Containment Vaccination Vaccine 52

The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

The Pharma Data

JULY 28, 2021

Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable. Very rare clotting disorders (TTS) were observed with both vaccines but these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.

Vaccination 52

Vaccination Vaccine Protein Medicine 52