Medicine, Vaccination and Vaccine - Clinical Research Informer

SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

Vaccination

Vaccination Vaccine Protein Medicine

Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines

Pharmaceutical Technology

OCTOBER 2, 2023

The Physiology and Medicine Prize has gone to two researchers whose work laid the foundation for Pfizer and Moderna’s Covid-19 vaccines.

Vaccination

Vaccination Vaccine Research Medicine

European regulator recommends Bavarian Nordic's vaccine for monkeypox

Bio Pharma Dive

JULY 22, 2022

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.

Regulation

Regulation Vaccination Vaccine Medicine

UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age.

Vaccination

Vaccination Vaccine Genetics Trials

Ghana becomes first country to approve Oxford’s malaria vaccine

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

Vaccination

Vaccination Vaccine Manufacturing Containment

The one-shot cervical cancer vaccine paradigm

Pharmaceutical Technology

FEBRUARY 24, 2023

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. Several cervical cancer vaccines are currently approved, including Merck’s nonavalent vaccine Gardasil 9 and GSK’s bivalent vaccine Cervarix.

Vaccination

Vaccination Vaccine Production Research

HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

Vaccination

Vaccination Vaccine Antibody Trials

Vaccines and various response rates

Drug Discovery World

MAY 30, 2024

DDW Editor Reece Armstrong speaks to Dr Katrina Pollock from the Oxford Vaccine Group at the University of Oxford. Dr Pollock is the Chief Investigator of the LEGACY03 clinical trial, a study aiming to investigate lymph nodes and vaccination responses across age groups. RA: Could you tell us about the LEGACY03 trial?

Vaccination

Vaccination Vaccine Scientist Clinical Trials

RVAC and University of Pennsylvania to develop mRNA vaccines

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.

Vaccination

Vaccination Vaccine Development Allergies

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

Vaccination

Vaccination Vaccine Protein Clinical Trials

Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

MAY 25, 2023

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. for serogroup W to 20.5

Vaccination

Vaccination Vaccine Immune Response Bacteria

Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.

Vaccination

Vaccination Vaccine Bacteria Protein

GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. GenScript ProBio CEO Dr Brian Min said: “We are delighted to enter into this strategic partnership with RVAC Medicines.

Vaccination

Vaccination Vaccine Gene Therapy Manufacturing

CHMP recommends approval for GSK’s RSV vaccine candidate

Pharmaceutical Technology

APRIL 28, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for use in older adults. This is the first time a vaccine candidate for the potential treatment of adult RSV patients has received a positive opinion.

Vaccination

Vaccination Vaccine Medicine Trials

Precision and personalized medicine: the leading companies in personalized cancer vaccines revealed

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in personalized cancer vaccines for the pharmaceutical industry.

Vaccination

Vaccination Vaccine Medicine

At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

MAY 8, 2024

On Tuesday, the EMA said it had accepted a request from AZ and withdrawn the company’s marketing authorization for its COVID-19 shot Vaxzevria.

Vaccination

Vaccination Vaccine Marketing Medicine

EC grants marketing authorisation for GSK’s RSV vaccine Arexvy

Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.

Vaccination

Vaccination Vaccine Marketing Manufacturing

Pfizer’s Covid-19 vaccine sales forecasts upgraded with sales of $37bn in 2022

Pharmaceutical Technology

FEBRUARY 21, 2023

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is the leading prophylactic vaccine for Covid-19 and is expected to generate an additional $2.8bn in sales in 2022 compared to GlobalData’s H1 2022 forecast. Comirnaty is the first globally approved Covid-19 vaccine.

Sales

Sales Vaccination Vaccine Medicine

Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn

Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.

Vaccination

Vaccination Vaccine Antibody Medicine

BMS, Repertoire Ink Potential $1.8B Deal to Find Vaccines for Autoimmune Diseases

BioSpace

APRIL 28, 2024

Bristol Myers Squibb’s deal announced Monday will see the pharma pay $65 million upfront to Repertoire Immune Medicines, which will develop autoimmune disease vaccines using its Decode discovery platform.

Vaccination

Vaccination Vaccine Medicine Development

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

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.

Vaccination

Vaccination Vaccine Immune Response Clinical Trials

Health Canada accepts Pfizer Canada’s bivalent RSV vaccine for review

Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The vaccine will be used to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in adults aged 60 and above.

Vaccination

Vaccination Vaccine Medicine Drugs

Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation

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.

Vaccination

Vaccination Vaccine Gene Therapy Medicine

Valneva seeks Health Canada approval for chikungunya vaccine

Pharmaceutical Technology

MAY 30, 2023

Valneva has submitted a regulatory application to Health Canada, seeking marketing approval for its chikungunya vaccine candidate, VLA1553. The vaccine is designed to be administered as a single shot and is intended for individuals aged 18 years and older. Valneva plans to make further regulatory submissions.

Vaccination

Vaccination Vaccine Medicine Trials

Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Pharmaceutical Technology

MAY 1, 2023

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. Both Pfizer and GSK have major approval decisions regarding the use of their RSV vaccines for older adults this May. What incentivises a country to cover a vaccine?

Vaccination

Vaccination Vaccine Regulation Production

World AIDS Vaccine Day 2024: Prospects in HIV Vaccine Research

XTalks

MAY 17, 2024

Every year on May 18th, the global community commemorates World AIDS Vaccine Day, also known as HIV Vaccine Awareness Day. Led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), World AIDS Vaccine Day emphasizes the importance of awareness and education in the fight against HIV/AIDS.

Vaccination

Vaccination Vaccine Research Immune Response

EC grants marketing authorisation for Takeda’s dengue vaccine

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. According to the results, the trial met the primary endpoint of overall vaccine efficacy by averting 80.2%

Vaccination

Vaccination Vaccine Marketing Trials

EU agencies back Covid-19 vaccine update ahead of autumn campaign

Pharmaceutical Technology

JUNE 7, 2023

Covid-19 vaccine compositions should be updated to provide protection against XBB Omicron variant strains in preparation for the autumn vaccination campaign, say EU agencies in a joint 6 June statement. There, organisations determined that the compositions of Covid-19 vaccines need to be updated to reflect the evolution of the virus.

Vaccination

Vaccination Vaccine Medicine Manufacturing

EC’s HERA signs Covid-19 vaccine procurement deal with HIPRA

Pharmaceutical Technology

AUGUST 2, 2022

The Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC) has entered a co-procurement framework contract for HIPRA HUMAN HEALTH’s bivalent recombinant protein Covid-19 vaccine. A total of 14 member states and countries are participating in this deal and can procure up to 250 million vaccine doses. .

Vaccination

Vaccination Vaccine Protein Medicine

EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine

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).

Vaccination

Vaccination Vaccine Marketing Clinical Trials

Video: Vaccine CARE Council Leader Mark Turner, MD

Velocity Clinical Research

MAY 21, 2024

“Next to clean water, vaccines are probably responsible for more saved lives than anything else we’ve done in medicine.” ” -Mark Turner, MD, Vaccine CARE Council Leader and Velocity Principal Investigator in Boise, ID.

Vaccination

Vaccination Vaccine Clinical Research Medicine

CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

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.

Vaccination

Vaccination Vaccine Trials Clinical Trials

Pharma’s vaccine pushback “too late”?

World of DTC Marketing

SEPTEMBER 7, 2020

IN SHORT: It may be too late for pharma to persuade the public that any COVID-19 vaccine is safe and effective as the FDA continues to be a political baseball in play. It’s now being reported that up to one-third of people may not get a COVID-19 vaccination when one become available. He decided to take part in the Vaccine trial.

Vaccination

Vaccination Vaccine Trials Pharma Companies

EMA CHMP recommends expanded CMA for Novavax’s Covid-19 vaccine as booster

Pharmaceutical Technology

SEPTEMBER 2, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.

Vaccination

Vaccination Vaccine Trials Clinical Trials

Novavax and SII receive registration for Covid-19 vaccine in South Africa

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. The vaccine showed efficacy, with an encouraging safety and tolerability profile, in the trials. .

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Indonesia grants EUA for US-developed Covid-19 vaccine

Pharmaceutical Technology

OCTOBER 3, 2022

Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. PT Bio Farma will manufacture 20 million doses of the vaccine this year.

Vaccination

Vaccination Vaccine Development Production

The State of Infectious Diseases: New Trivalent Flu Vaccine and More ft. Infectious Disease Experts Dr. William Schaffner and Dr. Kelly Moore – Xtalks Life Science Podcast Ep. 158

XTalks

MAY 8, 2024

In this episode, Ayesha spoke with William Schaffner, MD, Professor of Preventive Medicine Health Policy and Professor in the Division of Infectious Diseases at Vanderbilt University; and Kelly Moore, MD, MPH, President and CEO at Immunize.org and Associate Professor of Health Policy at Vanderbilt University.

Life Science

Life Science Vaccination Vaccine Medicine

Pfizer forecasts $15B sales boost from coronavirus vaccine orders

Bio Pharma Dive

FEBRUARY 2, 2021

The estimate for 2021 sales, which Pfizer splits with partner BioNTech, would make the vaccine one of the highest-selling medicines in the industry.

Sales

Sales Vaccination Vaccine Medicine

EMA accepts Moderna’s CMA submission for Covid-19 vaccine

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

Vaccination

Vaccination Vaccine Gene Therapy Clinical Trials

Novavax receives positive opinion from CHMP for full MA of Covid vaccine

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU).

Vaccination

Vaccination Vaccine Protein Immune Response

EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine

Pharmaceutical Technology

JULY 25, 2022

The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government.

Vaccination

Vaccination Vaccine Marketing Medicine

The real motivation for COVID vaccine development

World of DTC Marketing

MARCH 15, 2021

Pfizer, alone, is estimated to earn about $15 billion for their vaccine, and they had absolutely nothing to do with Operation Warp Speed. This finding further validates a recent study by the Berkeley Research Group that found nearly half of total spending on brand medicines went to the supply chain and other entities in 2018.

Vaccination

Vaccination Vaccine Development Sales

Pfizer pledges not-for-profit sale of medicines in low-income countries

Bio Pharma Dive

MAY 25, 2022

The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.

Medicine

Medicine Sales Branding Vaccination

First oral treatment for chronic kidney disease launched in China by Everest Medicine

Outsourcing Pharma

MAY 14, 2024

Today (May 14) Everest Medicines, a biopharmaceutical company focused on progressive medicines and vaccines, announced the successful launch of small molecule Nefecon, a delayed-release capsule, in China, with the first prescription issued.

Medicine

Medicine Vaccination Vaccine Clinical Development

SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines

Trending Sources

European regulator recommends Bavarian Nordic's vaccine for monkeypox

UK MHRA approves Takeda’s dengue vaccine Qdenga

Ghana becomes first country to approve Oxford’s malaria vaccine

The one-shot cervical cancer vaccine paradigm

HIV vaccines suffer setbacks but new approaches could turn the tide

Vaccines and various response rates

RVAC and University of Pennsylvania to develop mRNA vaccines

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Meningitis vaccine comes to the forefront with impressive study results

Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

CHMP recommends approval for GSK’s RSV vaccine candidate

Precision and personalized medicine: the leading companies in personalized cancer vaccines revealed

At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

EC grants marketing authorisation for GSK’s RSV vaccine Arexvy

Pfizer’s Covid-19 vaccine sales forecasts upgraded with sales of $37bn in 2022

Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn

BMS, Repertoire Ink Potential $1.8B Deal to Find Vaccines for Autoimmune Diseases

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Health Canada accepts Pfizer Canada’s bivalent RSV vaccine for review

Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation

Valneva seeks Health Canada approval for chikungunya vaccine

Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

World AIDS Vaccine Day 2024: Prospects in HIV Vaccine Research

EC grants marketing authorisation for Takeda’s dengue vaccine

EU agencies back Covid-19 vaccine update ahead of autumn campaign

EC’s HERA signs Covid-19 vaccine procurement deal with HIPRA

EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine

Video: Vaccine CARE Council Leader Mark Turner, MD

CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

Pharma’s vaccine pushback “too late”?

EMA CHMP recommends expanded CMA for Novavax’s Covid-19 vaccine as booster

Novavax and SII receive registration for Covid-19 vaccine in South Africa

Indonesia grants EUA for US-developed Covid-19 vaccine

The State of Infectious Diseases: New Trivalent Flu Vaccine and More ft. Infectious Disease Experts Dr. William Schaffner and Dr. Kelly Moore – Xtalks Life Science Podcast Ep. 158

Pfizer forecasts $15B sales boost from coronavirus vaccine orders

EMA accepts Moderna’s CMA submission for Covid-19 vaccine

Novavax receives positive opinion from CHMP for full MA of Covid vaccine

EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine

The real motivation for COVID vaccine development

Pfizer pledges not-for-profit sale of medicines in low-income countries

First oral treatment for chronic kidney disease launched in China by Everest Medicine

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