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.

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Vaccination Vaccine Genetics Trials 264

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.

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Vaccination Vaccine Manufacturing Containment 279

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.

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Vaccination Vaccine Medicine Development 111

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.

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Vaccination Vaccine Antibody Trials 293

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.

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Vaccination Vaccine Protein Clinical Trials 264

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.

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Vaccination Vaccine Gene Therapy Manufacturing 289

Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

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RNA Medicine Clinical Trials Clinical Trials 284

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

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Vaccination Vaccine Immune Response Bacteria 195

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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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.

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Vaccination Vaccine Marketing Manufacturing 147

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.

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Vaccination Vaccine Medicine Drugs 162

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.

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Vaccination Vaccine Antibody Medicine 264

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.

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Sales Vaccination Vaccine Medicine 246

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.

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Pharmaceutical Technology

MAY 24, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Recombinant viral vector-based medicinal preparations. However, not all innovations are equal and nor do they follow a constant upward trend.

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

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Vaccination Vaccine Marketing Trials 147

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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Vaccination Vaccine Immune Response Clinical Trials 214

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

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Vaccination Vaccine Protein Clinical Trials 363

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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Vaccination Vaccine Marketing Clinical Trials 147

BioPharma Reporter

FEBRUARY 28, 2023

Everest Medicines has celebrated the start of operations at its new global manufacturing site dedicated to mRNA vaccine production in Jiashan, Zhejiang Province, in China: with the facility boasting the capacity to produce 700 million doses of mRNA vaccines annually.

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Medicine Production Vaccination Vaccine 52

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.

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Sales Vaccination Vaccine Medicine 224

BioPharma Reporter

APRIL 30, 2024

Bristol Myers Squibb partners with Repertoire Immune Medicines to develop innovative vaccines aimed at treating autoimmune disorders more selectively and effectively

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Vaccination Vaccine Medicine Development 52

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. .

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Vaccination Vaccine Protein Medicine 162

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. .

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Vaccination Vaccine Clinical Trials Clinical Trials 147

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).

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Vaccination Vaccine Protein Immune Response 130

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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Vaccination Vaccine Trials Clinical Trials 59

BioPharma Reporter

OCTOBER 3, 2023

The Nobel Prize in medicine has been awarded to two scientists who developed the technology which led to the mRNA vaccines against COVID-19.

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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.

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BioSpace

SEPTEMBER 12, 2023

The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.

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Production Medicine Vaccination Vaccine 108

BioSpace

OCTOBER 19, 2021

?The National Academy of Medicine tapped 100 new members to its prestigious organization that represents some of the brightest minds in health and medicines. Here are some of them.

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Medicine Vaccination Vaccine 91

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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Vaccination Vaccine Development Bacterium 52

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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XTalks

MAY 10, 2024

Influenza viruses are highly mutable, which necessitates continuous monitoring and adjustments in vaccine formulations. These seasonal outbreaks can vary in severity, depending on the circulating strains of the virus and public health preparedness, including vaccination coverage and effectiveness.

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Vaccination Vaccine Life Science Nurses 52

BioPharma Reporter

NOVEMBER 18, 2021

The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.

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Vaccination Vaccine Medicine Marketing 145

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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Antibody Medicine Vaccination Vaccine 60

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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Vaccination Vaccine Engineer Clinical Trials 145

pharmaphorum

SEPTEMBER 6, 2022

The NHS is moving to the next phase of its SARS-CoV-2 vaccination programme, following health secretary Steve Barclay’s acceptance of advice from the Joint Committee on Vaccination and Immunisation (JCVI) to go ahead with rollout of Pfizer’s bivalent 30mg booster shot this week. million)” during the first year of vaccinations.

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Vaccination Vaccine Protein Medicine 98