pharmaphorum

JUNE 22, 2021

Sanofi and Translate Bio have started a first clinical trial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. Sanofi and Translate have been working together since 2018, when they agreed to develop mRNA vaccines for up to five infectious diseases.

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Vaccines Immunization Immunity 114

Express Pharma

JUNE 26, 2024

The success of the COVID-19 mRNA vaccines highlighted the major advantages of utilising mRNA technology in vaccine development. Consequently, the FDA has awarded a rising number of review designations to mRNA vaccines in recent years. Implementation of these vaccines is estimated to have prevented 14.4

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Vaccines Immunization Immunity 111

Pharmaceutical Business Review

AUGUST 14, 2024

The vaccine candidate is a virus-like particle (VLP)-based, adjuvanted vaccine designed for active immunisation against chikungunya virus (CHIKV) infection. The US regulator will make a decision on the vaccine approval under the Prescription Drug User Fee Act (PDUFA) by 14 February 2025.

Vaccines 105

Vaccines 105

STAT

FEBRUARY 13, 2023

Reed, who joined the drugmaker in 2018 from Roche, will be leaving “to pursue a new opportunity outside Sanofi,” according to a company statement. Sanofi’s R&D activity was criticized after falling behind other suppliers in the race for a Covid-19 vaccine. Continue to STAT+ to read the full story…

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Vaccines 246

pharmaphorum

NOVEMBER 29, 2021

The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. The post Report suggests UK’s national vaccine facility is on the block appeared first on.

Vaccines 105

Vaccines 105

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 Immunity 115

Express Pharma

JULY 26, 2023

Results are based on analysis of data from 278,375 adults in New Zealand who got the vaccine between April 2018 and July 2021. Most were aged 70 or older Getting vaccinated against shingles could significantly reduce the risk of suffering a stroke or heart attack from the virus, a new study has found. Most were aged 70 or older.

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pharmaphorum

JANUARY 19, 2023

Biotech Vaxxas has announced a partnership agreement with the 2017-established Coalition for Epidemic Preparedness Innovations (CEPI), in order to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology with preclinical testing of an mRNA vaccine patch. The agreement, worth $4.3 The agreement, worth $4.3

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Vaccines Immunization Immunity 105

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. cases per 100,000 people in 2018. “In The vaccine targets six different serotypes of borrelia bacteria.

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Vaccines 119

Express Pharma

APRIL 24, 2023

GlaxoSmithKline Pharmaceuticals (GSK) announced the launch of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in India, for the prevention of shingles (herpes zoster) and post-herpetic neuralgia in adults aged 50 years and above. Shingrix is a non-live, recombinant subunit vaccine to be given intramuscularly in two doses.

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Vaccines Diabetes Immunization Immunity 97

pharmaphorum

DECEMBER 14, 2022

The mRNA technology that was deployed so effectively in vaccines against COVID-19 has now been found to offer similar promise against cancer, according to Merck & Co and Moderna. The vaccine primes the immune system to attack the tumour cells, while Keytruda blocks an immunological ‘brake’ that protects the cancer.

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Vaccines Immunization Immunity 98

FDA Law Blog: Biosimilars

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Vaccines Adverse Reactions 64

STAT

OCTOBER 27, 2022

The investigation began in February and covers 2017, 2018, and 2019. The Italian branch allegedly sent the capital to foreign affiliates linked to a units based in Delaware called Pfizer Production and Pfizer Manufacturing. Continue to STAT+ to read the full story…

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Packaging Vaccines 246

Pharmaceutical Technology

JUNE 29, 2022

The Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted GlaxoSmithKline’s (GSK) regulatory application for recombinant, adjuvanted Zoster vaccine, Shingrix, for preventing shingles (herpes zoster) in at-risk adults of the age 18 years and above.

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Vaccines Immunity Immunization 64

Pharmaceutical Business Review

JANUARY 2, 2025

Brii Bio originally licensed BRII-179 from VBI Vaccines in December 2018 and has since expanded its exclusive license to global rights as of July 2023. The post Brii Biosciences acquires BRII-179 assets from VBI Vaccines appeared first on Pharmaceutical Business review.

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Vaccines Immunization Immunity 59

Express Pharma

JUNE 17, 2024

Based on CDC data from 2018-2021, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine). These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. Merck has announced that the U.S.

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Vaccines Immunization Immunity 105

pharmaphorum

AUGUST 16, 2022

One of the unexpected consequences of the COVID-19 vaccine race was that some top-tier vaccine companies like Merck, GSK and Sanofi ended up trailing the field, as their efforts to bring shots based on conventional technologies to patients were outstripped and outclassed by mRNA competitors from Pfizer/BioNTech and Moderna.

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Vaccines Packaging 98

pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

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Vaccines Immunization Immunity 111

pharmaphorum

JANUARY 10, 2022

The arrival of COVID-19 brought precious few positives, but one that emerged for the pharmaceutical industry was the emergence and validation of mRNA vaccine technology to prevent disease. Pfizer already has a head start on competitors in the field, having achieved the first US FDA approval for an mRNA vaccine, alongside BioNTech.

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Vaccines Immunization Immunity 111

pharmaphorum

JANUARY 5, 2023

The company develops mRNA therapeutics and vaccines , and the move will enable it to utilise the synthetic biology and enzyme tech of 2018-founded Japanese company OriCiro, which develops cell-free DNA synthesis and amplification technologies, and thereby expand Moderna’s portfolio. Biotech Moderna, Inc. and OriCiro Genomics K.K.

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Vaccines Immunity Immunization 97

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.

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Vaccines 52

Pharmaceutical Business Review

JULY 21, 2023

Earlier known as AV7909, CYFENDUS vaccine’s efficacy for post-exposure prophylaxis is only based on studies in animal models of inhalational anthrax. Emergent senior vice president, science and development Dr. Kelly Warfield said: “The approval of CYFENDUS vaccine is symbolic of Emergent’s longstanding partnership with the U.S.

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Vaccines Immunity Immunization Packaging 52

Pharmaceutical Technology

MARCH 24, 2023

Since the first human administration of the Bacillus Calmette-Guérin vaccine in 1921, no one has been able to successfully follow the vaccine’s path to become the next approved vaccine to tackle tuberculosis (TB). However, as the TB-related death toll remains high, the global need for another vaccine is steadily rising.

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Vaccines Health and Personal Care Stores Immunization Immunity 64

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

2014) June 2016 Vaxchora (Pax Vax Bermuda) Cholera vaccine for travelers $ 290 (June 2016) Aug 2017 Benznidazole (Chemo Research) Chagas disease UNK June 2018 Moxidectin (Medicines Devt for Global Health) Onchocerciasis, or river blindness UNK (May 2019) July 2018 Krintafel (GSK) P.

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Vaccines 52

European Pharmaceutical Review

OCTOBER 27, 2022

Since 2018, employment numbers in the industry have grown by 11 percent, totalling $2.9 For instance, small and mid-sized biotech companies invested heavily in developing vaccines. The investigation identified that in the pandemic, the economy reduced 1.5 percent of its workforce. trillion dollars in 2021. Sluggish economic growth.

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Pharmaceutical Manufacturing Vaccines Compounding 105

Pharmacy Is Right For Me

AUGUST 10, 2022

Dr. Brown is the National Field Director for Janssen Infectious Diseases & Vaccines. From 2015 through Jan 2018, I served as the U.S. We’re in the process of hiring a new Medical Science Liaison vaccines team that will focus on providing medical information about our vaccines portfolio, driving innovation.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 130

pharmaphorum

MAY 30, 2022

For comparison, there were just seven cases of monkeypox in the UK between 2018 and 2021, according to a just-published paper in The Lancet Infectious Diseases. No deaths have been reported from the infections. It says it has the capacity to produce around 30 million doses per year.

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Vaccines Labelling Immunization Immunity 105

pharmaphorum

NOVEMBER 23, 2021

Entrepreneur brothers Thomas and Andreas Struengmann – who hold a stake in COVID-19 vaccine developer BioNTech – have history in the generics sector, having sold drugmaker Hexal to Sandoz in 2005, said Reuters. It also said other private equity groups have taken an interest in Sandoz.

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Vaccines 97

pharmaphorum

FEBRUARY 10, 2022

It provides members with primary and preventive care, ongoing support for chronic conditions, and referrals to secondary and tertiary care, as well as prescription medicine services – the latter a result of its 2018 acquisition of PillPack. million employees – was shut down last year.

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Vaccines 104

Pharmafile

MARCH 15, 2023

This funding marks the third grant awarded from the Bill & Melinda Gates Foundation to DelSiTech since 2018. This funding marks the third grant awarded from the Bill & Melinda Gates Foundation to DelSiTech since 2018. read more

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Vaccines Drug Development 40

Express Pharma

JULY 24, 2023

Standard offering acquisitions have continued to decline since 2018. During the pandemic, the production capacity for vaccines and generally all injectables was stretched, driven by unexpected sharp increases in demand, and it would have been a wise investment to acquire these capabilities.

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Vaccines 98

pharmaphorum

OCTOBER 26, 2021

It exited a consumer healthcare joint venture with GlaxoSmithKline in 2018, and within the last decade also sold off its vaccines division to GSK, its animal health unit to Eli Lilly and a blood diagnostics business to Grifols.

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Generic Medicine Vaccines 116

Express Pharma

DECEMBER 19, 2024

The formulation underwent in-vitro testing on the MCF7 human breast cancer cell line in both 2018 and 2024. The innovation is the result of extensive development, rigorous testing, and validation to address the rising rate of breast cancer cases globally.

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Vaccines 98

pharmaphorum

FEBRUARY 3, 2021

billion in 2018, according to the latest BioIndustry Association (BIA) and Clarivate report, and represents a 1,000% increase on 2012. BIA points to a sharp dip in the number of new biotechs formed in 2020 – just eight compared to 30 in 2019 and 47 in 2018 – suggesting that the pandemic had a dramatic impact on entrepreneurship.

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Vaccines Drug Development 111

Eye on FDA

JANUARY 6, 2021

During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. One has to also take into account that the approval mechanism at FDA was particularly busy this year. While not full licensure, the mechanisms for approval did utilize agency resources.

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Compounding Vaccines 82

pharmaphorum

JULY 23, 2021

GSK chairman Sir Jonathan Symonds highlighted McNamara’s experience in integrating businesses on two prior occasions – combining Novartis and GSK’s consumer health businesses and overseeing the creation of the JV with Pfizer in 2018 – as evidence that he is the best candidate to be chief executive of the demerged company.

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Vaccines 111

pharmaphorum

MARCH 1, 2021

AstraZeneca has sold its stake in Moderna for more than $1 billion as the US biotech’s shares soared in value following its coronavirus vaccine breakthrough. Moderna was among the first companies to get a COVID-19 vaccine approved and has been selling it at a profit, even though the project was kick-started with around $1.5

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Vaccines 64