H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. First let’s look at some challenges and then opportunities.

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JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government under its existing supply agreement to 500 million. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. This press release features multimedia.

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NOVEMBER 19, 2021

government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral seeker, PAXLOVID ™ (PF-07321332; ritonavir), subject to nonsupervisory authorization from theU.S. government will acquire 10 million treatment courses to be delivered by Pfizer beginning latterly this time and concluding in 2022.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. The company is set to charge between $32 and $37 per dose.

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AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. Johnson & Johnson Announces Agreement with U.S.

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The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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The Pharma Data

OCTOBER 30, 2020

More recently, the FDA announced regulatory approval for the first treatment for Covid-19. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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Drug Discovery World

JANUARY 9, 2024

2024 is anticipated to be a transformational year for the pharma industry, with new modalities like antibody drug conjugates and AI/machine learning providing therapies for patients with limited treatment options. The therapy has shown positive results in Phase III trials in both breast and lung cancer.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

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The Pharma Data

NOVEMBER 9, 2021

Merck , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics moment blazoned that the United States government will exercise two of its options to buy a aggregate of1.4 government has now committed to buy a aggregate of roughly3.1 government has now committed to buy a aggregate of roughly3.1

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), announced today that it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. President of the Global Vaccine Business Unit, Takeda.

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Drug Discovery World

OCTOBER 9, 2023

Despite the size of the market and the global impact, there are currently no effective treatments. The reported MOD framework advances the mechanistic rationale of the clinical benefits on fatigue observed in our clinical trial with AXA1125 in the context of the combination’s mechanism of action.

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The Pharma Data

OCTOBER 26, 2021

Pfizer and BioNTech SE blazoned topline results from a Phase 3 randomized, controlled trial assessing the efficacity and safety of a 30-µg supporter cure of the Pfizer-BioNTech COVID-19 Vaccine in further than individualities 16 times of age and aged. The observed relative vaccine efficacity of95.6 (95 95 CI89.3,98.6)

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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. TAK-019 Clinical Trial.

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The Pharma Data

NOVEMBER 22, 2021

Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, NEW BRUNSWICK, N.J., NEW BRUNSWICK, N.J.,

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The Pharma Data

SEPTEMBER 23, 2020

Scientists around the globe are working on potential vaccines for coronavirus. The UK could be the first country in the world to carry out Covid “challenge trials” – where healthy volunteers are deliberately infected with coronavirus to test possible vaccines. How close are we to a coronavirus vaccine?

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Drug Discovery World

OCTOBER 20, 2022

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Government policies . Investment and collaboration .

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The Pharma Data

SEPTEMBER 10, 2020

Pascal Soriot, Chief Executive of AstraZeneca, said that the company’s vaccine could still be available this year, despite the clinical trials being paused after a participant became ill. . We could still have a vaccine by the end of this year, early next year.”. Conor Kavanagh. Source link.

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The Pharma Data

AUGUST 31, 2021

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant following positive interim Phase 1/2 results. GSK commitment to tackling COVID-19.

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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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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

SEPTEMBER 4, 2020

Dr Moncef Slaoui, the leading doctor involved with Operation Warp Speed, has said it is unlikely a vaccine for the US will be ready by November. . But Slaoui did say that he believes a vaccine will be available by the end of the year, and could possibly vaccinate between 20 and 25 million people.

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Drug Discovery World

JANUARY 2, 2024

More significantly, she says, with the boost from what we have learned from Covid, cancer vaccines will become a reality. She believes we might start to see a combination of vaccines with other immunotherapies or classical therapies out there, and that this will become more and more prevalent because of the nature of cancer.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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The Pharma Data

OCTOBER 6, 2021

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO.

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The Pharma Data

OCTOBER 29, 2021

Food and Drug Administration (FDA) has authorized for exigency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 times of age ( also appertained to as 5 to< 12 times). For this age group, the vaccine is to be administered in a two- cure authority of 10-µg boluses given 21 days piecemeal. EligibleU.S.

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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

JANUARY 19, 2021

20, 2021 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). SAN DIEGO, Jan. Dr. Dennis J. About Adamis Pharmaceuticals. The company’s subsidiary, U.S.

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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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The Pharma Data

DECEMBER 2, 2020

Pontarollo’s extensive experience both as a microbiologist and biotech executive strengthens our team and gives EYAM significant momentum as we prepare to enter animal trials.” Pontarollo’s primary areas of research and technical expertise include Genomics, Molecular Biology, Vaccine development and Immunology.

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Drug Discovery World

NOVEMBER 24, 2023

The success of the Covid-19 vaccines should be a reminder that professionals from all corners of the world and from many disciplines can work together effectively and efficiently to achieve a common goal. Facing imminent threats, it’s easier to be motivated by common goals than be caught up in differences.

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The Pharma Data

FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages.

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

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