Pharmaceutical Technology

AUGUST 17, 2022

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas.

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

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Drug Discovery World

JULY 24, 2023

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. Degarelix Accord (degarelix acetate), a generic medicine for the treatment of prostate cancer.

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pharmaphorum

SEPTEMBER 2, 2022

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The FDA has just authorised vaccines from the two companies that will specifically target the BA.4

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Vaccination Vaccine Protein Regulation 103

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. Since 2004, the NIAID has been championing the discovery and development of the cytomegalovirus (CMV) vector used to deliver the HIV vaccine material to the immune system without causing disease.

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pharmaphorum

NOVEMBER 12, 2020

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium.

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pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

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pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

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XTalks

JULY 1, 2021

Moderna has won approval from the European Medicines Association (EMA) for branding its COVID-19 vaccine with the name Spikevax. Now the vaccine maker is awaiting the same approval from the US Food and Drug Administration (FDA). Pfizer’s Comirnaty was the first COVID-19 vaccine brand name created by the company.

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Pharmaceutical Technology

NOVEMBER 7, 2022

5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg vaccine is indicated for usage as a booster shot for active immunisation against Covid-19. 5 Omicron variants’ spike protein and 25µg encoding for the virus’ initial strain. 5 versus mRNA-1273.

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Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market. Capacity Analysis.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . VLA15 is the only Lyme disease vaccine candidate currently in clinical development. Valneva Pfizer Report Positive Phase 2 Pediatric Data for Lyme Vaccine Candidate.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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XTalks

SEPTEMBER 8, 2020

The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.

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Drug Discovery World

NOVEMBER 20, 2023

Raquel Sanches-Kuiper , Vice President of Science and Applications at Evonetix, and Clare Whitewoods , Marketing Communications Manager at Evonetix, look at the benefits synthetic DNA brings to pharmaceutical development. The Covid-19 pandemic demonstrated the potential for mRNA vaccines.

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DNA Engineer Antibody Gene 69

Pharmaceutical Technology

FEBRUARY 24, 2023

It is developed based on protein engineering platform. Merck overview Merck is a biopharmaceutical company focused on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines and animal health products. It acts by targeting TGF-beta 1 and 3.

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Production Vaccination Vaccine Engineer 100

Drug Discovery World

OCTOBER 5, 2023

This free 2-hour Summit will take place online and will outline areas of advancement and opportunity in the cancer research market. Find out the answer to questions such as: Where is the opportunity in the cancer research market? What are the best research tools to aid development of new treatments and vaccines?

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Research Antibody Medicine RNA 52

pharmaphorum

SEPTEMBER 12, 2022

Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 5 has been recommended for authorisation by the EMA’s human medicines committee, shortly after the panel gave its blessing to jabs targeting the original BA.1 1 vaccines from Pfizer/BioNTech and Moderna, with around 26 million people eligible.

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Pfizer

FEBRUARY 9, 2023

Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program kimkevin Thu, 02/09/2023 - 15:05 Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program Friday, February 10, 2023 - 06:45am Share Phase 1/2 trial will enroll up to 900 healthy U.S.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. OspA is a surface protein expressed by the bacteria when present in a tick.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. COVID-19 Vaccine AstraZeneca , formerly AZD1222.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

MARCH 18, 2021

Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

JULY 28, 2021

Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable. Very rare clotting disorders (TTS) were observed with both vaccines but these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.

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Vaccination Vaccine Protein Medicine 52

pharmaphorum

FEBRUARY 4, 2022

The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future booster campaigns, according to the former chair of UK Vaccine Taskforce. It was also filed in the US earlier this month after development and manufacturing setbacks.

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

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The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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The Pharma Data

APRIL 26, 2022

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.

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Pharmaceutical Technology

MARCH 27, 2023

National Resilience will use the funding to establish a significant domestic biomanufacturing capacity and capabilities for vaccines, nucleic acids including mRNA, and biologics including antibodies, proteins and multi-specifics. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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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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The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,

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pharmaphorum

NOVEMBER 10, 2021

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony. The patent has been filed but not yet awarded.

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The Pharma Data

MAY 27, 2022

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

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The Pharma Data

JUNE 1, 2022

has been appointed Senior Vice President and Head of the Company’s Vaccine Research & Development (R&D) organization effective August 1, succeeding Kathrin U. Annaliesa is a world-class scientist with a track record of delivering both vaccines and therapeutics in pioneering new areas of science and where there is urgent unmet need.

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