BioSpace

OCTOBER 26, 2020

While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their.

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Drug Discovery Today

JULY 7, 2022

Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess (..)

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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Drug Discovery World

FEBRUARY 20, 2024

A five-year contract totalling up to $31 million including programme options has been awarded to Ginkgo Bioworks to discover and develop next-generation vaccine adjuvants. Licensing for human use Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination.

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XTalks

MAY 28, 2024

In a move signaling a major shift in influenza prevention strategies, CSL Seqirus, a global leader in flu vaccines, has transitioned from quadrivalent to trivalent formulations for the upcoming 2024/25 flu season in the US.

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XTalks

OCTOBER 15, 2021

Moderna is facing criticism for refusing to share its COVID-19 vaccine formula amid global vaccine shortages and continuing COVID-19 vaccine inequities. However, on Tuesday, Moderna told The Associated Press that it has “no plans to share the recipe for its COVID-19 vaccine.” Addressing COVID-19 Vaccine Inequities.

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pharmaphorum

OCTOBER 7, 2021

Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. of Africans have been fully vaccinated against COVID-19, and just 15 African nations have met the agency’s objective of 10% coverage.

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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 UK also sank money into a manufacturing facility in Scotland owned by French biotech Valneva as the pandemic gathered pace in 2020, tied to a €1.4

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BioPharma Reporter

SEPTEMBER 2, 2021

Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.

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Drug Discovery World

OCTOBER 3, 2023

The R21/Matrix-M malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG). The developers expect additional regulatory approvals will follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out next year.

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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XTalks

DECEMBER 20, 2021

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. CEO and Co-founder of BioNTech.

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pharmaphorum

FEBRUARY 19, 2021

billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. Novavax has signed a deal to provide 1.1

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Pfizer

DECEMBER 13, 2021

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. A massive manufacturing undertaking. Anonymous (not verified). Mon, 12/13/2021 - 11:40.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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Pfizer

APRIL 26, 2023

But the underlying question is always the same: How will Pfizer and BioNTech ensure a seamless distribution of our vaccine? With the pandemic still raging, our vaccine will be in high demand and, upon authorization or approval, rapidly utilized to help beat back the virus. In the U.S.,

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pharmaphorum

SEPTEMBER 8, 2022

A malaria vaccine developed by members of the University of Oxford team behind the AstraZeneca COVID-19 jab has been hailed as a possible game-changer in the fight against the deadly parasitic infection. The post High hopes as new malaria vaccine shows unprecedented efficacy appeared first on.

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Pfizer

APRIL 14, 2023

Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines kimkevin Fri, 04/14/2023 - 15:38 Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines Friday, January 22, 2021 - 11:21am Share We have crossed another milestone in the fight against COVID-19.

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Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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Pfizer

SEPTEMBER 28, 2022

5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age. 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

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pharmaphorum

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. The post Bayer joins the COVID-19 vaccine push, backing CureVac shot appeared first on.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

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pharmaphorum

NOVEMBER 12, 2021

AstraZeneca has said it plans to start making a small profit from sales of its COVID-19 vaccine Vaxzevria, which brought in just over $1 billion in sales in the third quarter, after selling it at cost since it was first made available. By the end of September AZ and sub-licensing partners had delivered more than 1.5

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Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .

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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.

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BioTech 365

SEPTEMBER 18, 2020

Bintai Kinden Corporation Berhad (www.bintai.com.my) is an investment holding company headquartered in Malaysia with operations throughout South-East Asia, China, and the Arabian Gulf Region Upfront licensing fee of $2.5

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BioTech 365

OCTOBER 15, 2020

Aegis Life is launched to pursue US-based development and commercialization of SARS-CoV-2 vaccine using the Entos Fusogenix technology and to support manufacturing and distribution of millions of DNA vaccine doses globally Aegis Life signs a license agreement with Nature Technology … Continue reading →

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