European Pharmaceutical Review

OCTOBER 10, 2022

The RNA Centre of Excellence is the only UK site equipped to develop and manufacture millions of doses of a messenger and self-amplifying RNA vaccines. RNA technology enables vaccines to be developed rapidly, offering potential solutions for diseases such as cancer and cardiovascular disease through the creation of novel therapies.

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Vaccines 95

Pharmaceutical Technology

JANUARY 25, 2023

It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022. Spikevax is an mRNA vaccine that is approved in 20 geographies including the US, EU, and, the UK. The vaccine first gained Emergency Use Approval in December 2020 in response to the Covid-19 pandemic.

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Vaccines 59

Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

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Vaccines FDA Immunization 64

European Pharmaceutical Review

JANUARY 5, 2023

Moderna’s two Omicron-targeting bivalent COVID-19 vaccines have been approved in more than 70 countries. finalised a strategic partnership to create a state-of-the-art mRNA vaccine research, development, and manufacturing facility in the UK. Moderna’s mRNA therapeutics strategy. At the end 2022, Moderna, Inc.

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Vaccines 59

Pharmaceutical Technology

MAY 16, 2023

This growth is expected to continue, with a 62% growth in annual consensus sales forecast from 2023 to 2028, fuelled by the company’s semaglutide portfolio, according to GlobalData’s report, ‘Looking ahead to 2023 – the future of pharma’. Novo Nordisk reported an 18.2%

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Vaccines FDA 52

PharmaShots

MAY 2, 2023

The US FDA was granted the expanded conditional approval authority in the Animal Drug User Fee Act of 2018 with the program planned to sunset in 2028 The efficacy of molidustat oral suspension had been established based on the results of a study conducted in 2 phases in 23 cats aged 4-17yrs.

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FDA Vaccines 45

Pharmaceutical Technology

MAY 26, 2023

These figures are only expected to grow in the coming years, with sales forecasted to reach over $150 billion by 2028. GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies.

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Immunization Vaccines Compounding Insurance 105

European Pharmaceutical Review

AUGUST 21, 2023

Part of this growth was driven by Arexvy, which in May 2023, became the world’s first approved RSV vaccine for older adults. billion sales globally by 2029, this could offset Keytruda’s decline sales expected after its loss of exclusivity in 2028, GlobalData highlighted. Merck & Co Merck & Co reached third in ranking, due to 8.4

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Vaccines FDA 85

pharmaphorum

AUGUST 8, 2022

billion in 2028 – a leap forward from the $195 million it made last year and $127 million in the first half of 2022. The deal is another example of Pfizer splashing out on business development thanks to windfall cash generated by its COVID-19 vaccine Comirnaty and oral antiviral therapy Paxlovid.

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Vaccines FDA 103

European Pharmaceutical Review

FEBRUARY 14, 2023

Recently there have been several key advances in the clinical development of messenger RNA (mRNA) vaccines, including vaccines for RSV and a personalised cancer vaccine. Progress on mRNA vaccines for RSV Moderna’s mRNA vaccine mRNA-1345 demonstrated vaccine efficacy of 83.7

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Vaccines Immunization FDA 94

Hospital Pharmacy Europe

NOVEMBER 23, 2023

According to the Government, the new VPAG deal – which will run until 31 December 2028 – will help keep the price of vital branded medicines affordable for the NHS. Victoria Atkins, health and social care secretary, said: ‘Millions of NHS patients will benefit from this momentous, UK-wide agreement.

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Hospitals Vaccines 52

European Pharmaceutical Review

AUGUST 15, 2022

According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. million more children missed the third dose of polio vaccine and 3.5 million more than in 2019.

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Vaccines Communication 88

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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Packaging Vaccines Documentation FDA 100

European Pharmaceutical Review

OCTOBER 12, 2023

With the goal of supplying cell therapies, vaccines and other essential medicines such as antibody drugs to patients, the facilities aim to address major supply challenges and navigate the intricacies of producing fragile biological products. Subject to planning permission, the site is expected to be opened by 2028. The new £26.4

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Vaccines Dosage Pharmaceutical Companies Pharmaceutical Companies 87

PharmaShots

JUNE 1, 2023

PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. The technology can potentially be applied to any type of cancer.

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Immunization Vaccines Health and Personal Care Stores Labelling 40

The FDA Law Blog

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. covered insulin product or vaccine). Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024. Final Guidance at 2. state pharmaceutical assistance programs).

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Labelling Compounding Payment Processing Vaccines 105

pharmaphorum

NOVEMBER 4, 2021

Medicare would negotiate up to 10 drugs per year starting in 2023, with the prices taking effect two years later, rising to 20 medicines per year in 2028. “This discourages drug companies from abusing laws to prolong their monopolies, while encouraging investments in research and development of new cures.”

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Vaccines 52

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. billion by 2028. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

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Vaccines Documentation Communication 52