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. In addition, no serious safety concerns linked to the vaccine were observed.

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Pharmaceutical Technology

APRIL 20, 2023

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time.

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ACRP blog

MAY 16, 2023

Clinical trials have been the foundation of medical research for almost 250 years. James Lind, a Scottish naval surgeon and physician, is widely credited with performing the first comparative clinical trial. For that reason, every May 20 we proudly join the scientific community in celebrating Clinical Trials Day.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. Additionally, how do you ensure that the vaccine distribution is equitable?

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XTalks

FEBRUARY 21, 2024

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

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XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. This data also comprises two Phase III clinical trials: a trial in the UK and PREVENT-19 in the US and Mexico.

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Pharmaceutical Technology

DECEMBER 9, 2022

The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. The approval in the European Union (EU) was backed by data from 19 Phase I, II, and III clinical trials in over 28,000 children and adults.

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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.

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WCG Clinical

JANUARY 4, 2024

Download report Intelligently Connecting Data and Insight to Navigate the Clinical Research Trends of Tomorrow Advancing health is all about connections. Connecting people, data, insights, and technology for a better, more efficient clinical trial experience. Despite this improvement, disconnects remain.

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Pharma Mirror

SEPTEMBER 11, 2022

Bandung, W Java, Indonesia, PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.

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Pharmaceutical Technology

NOVEMBER 2, 2022

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU).

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XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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STAT News

NOVEMBER 15, 2022

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. Read the rest…

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Drug Discovery World

JANUARY 8, 2024

UK-based Barinthus Biotherapeutics, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford are working together to fast-track the development of a vaccine candidate for the prevention of Middle East Respiratory Syndrome (MERS).

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Scienmag

JANUARY 1, 2021

Data from Phase 3 clinical trial confirm vaccine is effective Credit: NIH WHAT: The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine.

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Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 1 vaccine as well as the safety results from a clinical trial underway. 5 sub-variants.

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Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. 1 targeting vaccine in Europe, our BA.4/BA5

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STAT News

JANUARY 12, 2023

SAN FRANCISCO — When BioNTech was founded in 2008, messenger RNA therapies and vaccines were still an unproven idea. The German company has now shipped out billions of doses of its mRNA Covid-19 vaccine worldwide — and BioNTech’s leaders say that’s just the beginning of a larger revolution in medicine.

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Scienmag

JUNE 27, 2022

A major clinical trial, led by experts at the University of Nottingham working in partnership with several Universities and NHS hospitals, has found that by interrupting the treatment of vulnerable people on long-term immune supressing medicines for two weeks after a COVID-19 booster vaccination, their antibody response to the jab is doubled.

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Scienmag

DECEMBER 15, 2020

Credit: BAT / KBP Investigational New Drug application approved by the FDA for COVID-19 candidate vaccine, allowing BAT to progress into a Phase I clinical trial in adult volunteers Vaccine candidate created using innovative plant-based technology Vaccines manufactured using BAT’s vaccine platform have the potential to be stable at room temperature (..)

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Pharma in Brief

JUNE 26, 2022

On June 22, 2022, the Canadian Institutes of Health Research ( CIHR ) announced the launch of the Clinical Trials Fund ( CTF ), which will inject funding into Canada’s clinical trials environment. The Clinical Trials Fund. Clinical Trials Training Platforms ( CTTP ). Clinical Trials Projects.

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Medical Xpress

MARCH 1, 2023

Vaccination against SARS-CoV-2, the virus responsible for COVID-19, may lessen the severity and duration of long COVID in those with persistent symptoms after infection, suggests a study that closely imitates a randomized clinical trial, and published in the open access journal, BMJ Medicine.

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XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Medical Xpress

APRIL 7, 2023

After helping to develop and test new mRNA technologies for COVID-19 vaccines, University of Maryland School of Medicine (UMSOM) researchers and scientists are turning their attention to utilizing this innovative technology to ward off other infectious diseases like malaria and influenza.

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BioSpace

JUNE 8, 2022

Takeda announced results from its Phase III clinical trial on TAK-003, its dengue fever vaccine candidate, at the Northern European Conference of Travel Medicine.

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Drug Discovery World

APRIL 18, 2024

For the first time, a controlled human infection model for tuberculosis (TB) has been developed and could help with the future development of TB vaccines. The team states that it’s the first step towards establishing a challenge model that can be used to test new vaccines for TB.

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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. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. 1 subvariant. 1 subvariant.

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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.,

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Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted 1-adapted vaccine. 5-adapted bivalent vaccine will be made readily available for shipping.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

Your healthcare practitioner can access the sequencing results, and artificial intelligence (AI) and quantum computing will analyse these records and support the practitioner in making future clinical decisions. It could be that you are lucky, and there is already a cancer vaccine on the market that you will get priority for.

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Drug Discovery World

APRIL 13, 2023

The R21/Matrix-M malaria vaccine has received regulatory clearance for use in Ghana by the country’s Food and Drugs Authority, making it the first country to approve the vaccine. The vaccine has been approved for use in children aged five to 36 months, the age group at highest risk of death from malaria.

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Drug Discovery World

AUGUST 3, 2023

Bimervax from HIPRA Human Health has been authorised in the UK after meeting the Medicines & Healthcare products Regulatory Agency’s (MHRA) required safety, quality and effectiveness standards. It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator.

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Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety.

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