The Pharma Data

NOVEMBER 17, 2021

AstraZeneca continues to engage with governments, multilateral organisations and collaborators to ensure broad and equitable access to the vaccine. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. 3,4,5,6,7). About AstraZeneca.

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The Pharma Data

MARCH 26, 2021

It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. Across government, action is being taken to enforce these tough regulations. SURVIVING THE VIRUS: ‘Our medical science is struggling to catch-up’ COVID-19: How are dentists coping? ” Image copyright. .

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

DECEMBER 19, 2020

Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. government by the end of December 2020. W911QY-20-C-0100.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

OCTOBER 14, 2020

The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. The research encompasses two projects. The study led by Dr. Ilya Trakht, Ph.D., About TNX-1800. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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The Pharma Data

JANUARY 12, 2021

The Swiss Federal Government has secured 7.5 Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. million doses of the COVID-19 Vaccine Moderna. About Moderna.

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The Pharma Data

NOVEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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The Pharma Data

SEPTEMBER 9, 2020

BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. About the Phase 2/3 Study. In the late-stage trial, Pfizer and BioNTech are studying a 30µg dose level in a 2-dose regimen among up to 30,000 participants aged 18 to 85 years. billion doses by the end of 2021.

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The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

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The Pharma Data

JUNE 24, 2021

This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

SEPTEMBER 12, 2020

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

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The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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The Pharma Data

DECEMBER 21, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. For more than 150 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

DECEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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The Pharma Data

AUGUST 20, 2020

We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. “The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials.

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The Pharma Data

OCTOBER 29, 2020

We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan.

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Agency IQ

JUNE 29, 2023

The amendment would make clear that the establishments that manufacture HCT/Ps regulated as devices are required to follow the registration and listing procedures in 21 CFR part 807. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

JANUARY 12, 2021

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. million doses. . We are pleased to work with the U.S.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on supply of bamlanivimab and etesevimab together.

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The Pharma Data

SEPTEMBER 21, 2020

Licensed premises such as pubs and bars will need to shut by 23:00 every night. Live: Welsh Government coronavirus update. ‘People just come out earlier’ Customers at the The Pen and Wig pub in Newport on Monday were not convinced a pub curfew would help to control the virus. What are the restrictions? in Newport.

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Codon

FEBRUARY 27, 2024

Patient YY’s neighbors quickly started to become infected, passing on the virus in turn. While the consensus that emerged among experts was that the virus spread primarily via airborne transmission , it also made use of another route: fomite transmission. Puzzled, epidemiologists sought to understand the source of the outbreak.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. For more information, visit www.avantgen.com.

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The Pharma Data

NOVEMBER 20, 2020

Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. Yancopoulos, M.D., President and Chief Scientific Officer of Regeneron.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.

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The Pharma Data

SEPTEMBER 12, 2020

It comes as one scientist warned the UK was “on the edge of losing control” of the virus. “There is an anticipation that everyone is going to have a big last binge, but people are starting to get fearful and a lot of licensed premises have already been clamped down on by the police,” he said.

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The Pharma Data

NOVEMBER 21, 2020

government allocation program. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. government and Regeneron signed an agreement for this initial supply of REGEN-COV2.

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The Pharma Data

JULY 29, 2021

Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. About HilleVax.

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The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. These building blocks are designed to target different sites on the virus for multiple concurrent effects.

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The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

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