European Pharmaceutical Review

AUGUST 2, 2023

A new COVID-19 vaccine has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). Bimervax is now the ninth vaccine to be authorised by the UK’s independent medicines regulator to treat the virus. This is an additional ingredient designed to trigger a stronger immune response.

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Vaccines Immunization 98

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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Vaccines Immunization FDA 98

European Pharmaceutical Review

SEPTEMBER 1, 2023

GlobalData’s research showed that within the clinical trials landscape, there are 36 mRNA-based products being investigated in 65 Phase I-III trials across multiple cancer indications. Additionally, there are 178 mRNA-based oncology therapies in total across all clinical stages of development. subvariant. subvariant.

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Immunization Vaccines 97

STAT

DECEMBER 12, 2022

to receive a Covid-19 vaccine outside of a clinical trial. A study released Tuesday by the Commonwealth Fund shows that in those two years, the Covid vaccines have averted over 3 million deaths in the U.S. Without vaccines, the country would have experienced four times as many deaths, 1.5 times more infections, and 3.8

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Vaccines Hospitals Immunization 142

pharmaphorum

OCTOBER 11, 2022

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immune response to the virus. Other efforts to develop a nasally-delivered COVID-19 vaccine have met with greater success.

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Vaccines Immunization 115

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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Vaccines Immunization 110

European Pharmaceutical Review

JANUARY 23, 2023

We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine,” stated Per Norlén, CEO at Denmark-based Evaxion. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We Moderna, Inc.

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Immunization Vaccines FDA 124

The Checkup by Singlecare

SEPTEMBER 12, 2023

Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

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Vaccines Immunization Pharmacy Program Director Chemotherapy 105

European Pharmaceutical Review

DECEMBER 15, 2023

Moderna and MSD have announced follow-up data from the Phase IIb clinical trial evaluating cancer vaccine mRNA-4157 (V940) in combination with MSD’s Keytruda in patients with resected high-risk melanoma. Keytruda is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells.

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Vaccines Research Laboratories Immunization 103

European Pharmaceutical Review

AUGUST 16, 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. 1) and the original 2020 strain.

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Vaccines Immunization 104

Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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Vaccines Immunization 114

pharmaphorum

MAY 19, 2022

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. There are hopes that its mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.

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Vaccines Immunization 145

European Pharmaceutical Review

MAY 12, 2023

A BioNTech-led Phase I trial demonstrated preliminary evidence that adjuvant autogene cevumeran, a personalised mRNA neoantigen vaccine, in combination with atezolizumab (Genentech) and mFOLFIRINOX can induce substantial T cell activity in pancreatic ductal adenocarcinoma (PDAC). Can an mRNA vaccine stimulate T cell response?

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Vaccines Immunization Chemotherapy 95

European Pharmaceutical Review

AUGUST 17, 2023

The National Institutes of Health (NIH) has chosen contract development, and manufacturing organisation (CDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19. MHRA authorises new COVID-19 vaccine What will the intranasal vaccine manufacturing project involve?

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Vaccines Immunization 93

European Pharmaceutical Review

NOVEMBER 1, 2023

In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. WHO referred to 61 bacterial vaccine candidates in diverse stages of clinical development.

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Vaccines Immunization 105

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

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Vaccines Immunization Communication 126

pharmaphorum

SEPTEMBER 27, 2022

Ben Hargreaves finds that the next step to enhance these treatments further could be to find synergies with emerging therapies employing similar modes of action, such as therapeutic cancer vaccines. One area that is becoming more widely discussed with the potential to be added to this group is that of therapeutic cancer vaccines.

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Vaccines Immunization 97

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Vaccines Immunization FDA 98

European Pharmaceutical Review

DECEMBER 12, 2023

He discusses why NK cell therapy’s ability to generate ‘synthetic immunity’ in the body means this modality holds potential as an anti-cancer treatment. Innate Pharma is an international clinical-stage biotechnology oncology company based in France. Can you describe Innate Pharma’s clinical stage pipeline?

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Immunization Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 113

Pharmafile

FEBRUARY 13, 2023

Scancell Holdings PLC has shared “highly encouraging” results from its phase 1 clinical trial of its COVID-19 vaccines, says chief executive officer, Lindy Durrant. read more

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Vaccines Immunization 78

pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. Clinical data show strong neutralising antibody responses against Omicron BA.1, 1 subvariant of Omicron.

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Vaccines Immunization FDA 121

pharmaphorum

SEPTEMBER 22, 2022

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. Antibodies cover the pathogen of the virus and neutralise it.

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Vaccines Immunization 97

pharmaphorum

FEBRUARY 9, 2022

In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.

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Vaccines Immunization Compounding Pharmaceutical Companies 134

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility. Karim Beguir – InstaDeep.

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Immunization Vaccines 115

pharmaphorum

FEBRUARY 25, 2021

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. A nasal delivery method will also produce an immune response at the point where the virus enters the body.

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Vaccines Immunization 110

The Checkup by Singlecare

NOVEMBER 30, 2023

Acetaminophen may also blunt the effects of other medications that impact the immune system, including some medicines used to manage cancer diagnoses and even the immune response following vaccinations. It does not reduce inflammation, unlike non-steroidal anti-inflammatory drugs (NSAIDs).

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Immunization Vaccines FDA Labelling 98

European Pharmaceutical Review

DECEMBER 14, 2022

and Merck have announced that a Phase IIb trial ( NCT03897881 ) of a personalised mRNA cancer vaccine (mRNA-4157/V940), in combination with KEYTRUDA ® , Merck’s anti-PD-1 therapy, demonstrated the first randomised evidence that a personalised neoantigen approach may be beneficial in treating melanoma. Moderna, Inc.

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Vaccines Immunization 112

Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

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Vaccines Research Laboratories Immunization 115

Pharmaceutical Technology

MAY 11, 2023

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later.

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Vaccines Immunization 138

European Pharmaceutical Review

JULY 12, 2023

The first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa, has been prequalified by the World Health Organization (WHO). MenFive ® has been developed through a 13-year collaboration between the world’s largest vaccine manufacturer Serum Institute of India Pvt.

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Vaccines Immunization 97

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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Vaccines Immunization 98

European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Professor Hill added that the “partnership with the [vaccine’s manufacturer] has been key to successful very large-scale manufacturing and rapid development.”

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Vaccines Immunization FDA 110

pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. It will also cover some infectious disease targets.

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Vaccines Immunization 110

European Pharmaceutical Review

OCTOBER 21, 2022

GSK announced Shingrix (Zoster Vaccine Recombinant, Adjuvanted), the first approved shingles vaccine to combine a non-live antigen with a GSK-made adjuvant, can prevent shingles (herpes zoster) for at least decade. An interim analysis conducted over more than four years of long-term follow-up (LTFU) showed vaccine efficacy was 81.6

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Vaccines Immunization 94

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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Immunization Vaccines Hospitals 107

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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Vaccines Immunization FDA Hospitals 105

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

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Vaccines Immunization 98