The Pharma Data

DECEMBER 11, 2020

The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV. Source link.

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The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

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The Pharma Data

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. Eligible U.S.

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The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above. Results of the Phase 2 trial will inform the Phase 3 protocol. About the Phase 2 study.

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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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The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.” About PREVENT-19.

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The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. government. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

NOVEMBER 18, 2020

Azar said the government expects to have 40 million doses of the two vaccines available for distribution by the end of the year, enough to vaccinate about 20 million Americans, with production continuing to accelerate in the new year. The only notable adverse events were fatigue and headache in a small percentage of participants, 3.8

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The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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The Pharma Data

JANUARY 22, 2021

Pending ImmunityBio’s discussions with the US Food and Drug Administration , the oral vaccine will enter Phase 1 trials as a prime and boost, and will be explored as an option to provide healthcare providers with a boost to subcutaneous vaccinations.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. link] 1. About ImmunityBio.

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The Pharma Data

NOVEMBER 23, 2020

government has already acquired millions of doses from the domestic and European companies and pledged to offer them free to the U.S. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. In Phase III trials, it demonstrated 95% efficacy. Also, the U.S. Type: mRNA.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

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Drug Target Review

APRIL 3, 2024

Our research demonstrated that GDF-15 acts as a versatile tool for tumours to inhibit the mounting of an effective antitumoral immune response at various steps of its process, including antigen presentation, immune cell activation, and their migration and infiltration into the tumour. in North America) in late 2017.

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The Pharma Data

NOVEMBER 27, 2020

This week, another pharma company revealed a new technology device that can detect if a patient is infectious or not, while the Russian government published results of its Sputnik V vaccine, claiming it is more than 95 per cent efficient 42 days after the first dose. Read on to for the full insight.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial. Argentina and Brazil.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. government’s Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19. immediately.

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The Pharma Data

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication.

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The Pharma Data

JUNE 24, 2021

“We appreciate the agency’s thorough and efficient review of the data from our clinical trial, and look forward to seeing more people across Europe immunized as a result of today’s decision.”. The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years.

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The Pharma Data

SEPTEMBER 5, 2021

“This new analysis from NAVIGATOR is exciting for the up to one in five severe asthma patients who have comorbid nasal polyps,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the NAVIGATOR trial.

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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

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

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

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The Pharma Data

MAY 7, 2021

Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. 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

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800.

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DrugBank

JULY 18, 2024

Adjuvants are substances added to vaccines to enhance the immune response. They work by decreasing the solubility of the vaccine, which sustains the release of the drug and prolongs the immune response. Even after a vaccine is approved and distributed, the pharmaceutical industry's responsibility does not end.

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DrugBaron

APRIL 13, 2020

If enough people have become immune, and critically can neither suffer symptoms nor act as a carrier for the virus, then immunity will replace social distancing as the key breaker of transmission chains. The solution is a test for the immune response to the virus (often called a “serology test”).

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

JANUARY 25, 2021

In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Initial efficacy data are anticipated in the first quarter and the phase 2/3 trials are expected to wrap up in May.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

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The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

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