Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. Buy the report here.

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Production Vaccination Vaccine Immune Response 100

pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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Vaccination Vaccine Recombinant DNA Technology Trials 89

pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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Vaccination Vaccine Trials Immune Response 98

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.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

pharmaphorum

NOVEMBER 20, 2022

One standout success we have all benefitted from is vaccine development, with notable vaccines from Pfizer/BioNTech, AstraZeneca, and Moderna. New hurdles from COVID-19 vaccine development. Trials testing SARS-CoV-2 vaccines saw high enrollment, which reduced the time between each clinical trial phase.

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Vaccination Vaccine Development Clinical Development 98

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

Camargo

JULY 27, 2021

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. PK Planning for Gene Therapy Development Programs.

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Gene Therapy Gene Gene Editing Genetics 238

XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals.

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Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

JANUARY 31, 2022

It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccine development. Innovative new vaccines are being created more rapidly than ever before.

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Vaccination Vaccine Development Marketing 97

Scienmag

APRIL 22, 2021

Dose-sparing regimens and intradermal delivery have important implication for rapid clinical development of effective, well-tolerated and easy-to-distribute vaccines against MERS and other emerging coronaviruses.

DNA 61

DNA Vaccination Vaccine Immune Response 61

XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.

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Drug Delivery Drugs Immune Response Allergies 111

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. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. GAITHERSBURG, Md.,

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Clinical Development Vaccination Vaccine Development 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 UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Vaccination Vaccine Trials Immune Response 69

Pharmaceutical Technology

JUNE 5, 2023

Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. It was also under development for treatment of neuroblastoma. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report.

Immune Response 130

Immune Response Development Clinical Trials Clinical Trials 130

Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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Vaccination Vaccine Medicine Clinical Trials 100

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. AZ to combine vaccine with Russian rival.

Immune Response 72

Immune Response Trials Vaccination Vaccine 72

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains.

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Vaccination Vaccine Development Immune Response 52

pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The post Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab appeared first on.

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Vaccination Vaccine RNA Immune Response 59

The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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Vaccination Vaccine Trials Immune Response 52

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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Vaccination Vaccine Immune Response Protein 52

pharmaphorum

JANUARY 25, 2021

Merck & Co is to axe development of two COVID-19 vaccine candidates, focusing on development of two therapies instead following disappointing results in early trials. US-based Merck & Co said the decision followed findings from phase 1 clinical studies of the vaccines codenamed V590 and V591.

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Vaccination Vaccine Immune Response Development 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus. The data showed a 98.9

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

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 Vaccination Vaccine 76

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

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

The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

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Vaccination Vaccine Immune Response Protein 52

The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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Vaccination Vaccine Antibody Licensing 52

The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The candidate vaccines were given in two doses, three weeks apart. CHENGDU, China , Feb. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

Vaccination 52

Vaccination Vaccine Development Clinical Trials 52

pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. This means that the vaccine won’t be ready until next year, Sanofi’s chief executive Paul Hudson told Le Journal du Dimanche last month.

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Clinical Trials Clinical Trials Trials Vaccination 52