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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The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. 9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications. Nature reviews Drug discovery 18 , 358-378 (2019).

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The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

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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. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer?BioNTech

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The Pharma Data

OCTOBER 26, 2020

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located.

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The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients.

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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. There was a 1.08

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The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. About Foralumab.

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The Pharma Data

NOVEMBER 19, 2020

The study not only confirms treatment should start early, but suggests that treatment should focus on addressing the causes of this far earlier trigger. The findings were that the death rate in several demographics exceeded the same period in 2019. It has not yet been confirmed to also occur in humans. The data was from the U.S.

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The Pharma Data

JULY 6, 2021

At ISTH, we are sharing data across all our innovative approaches and collectively, the data reinforce how our pipeline and portfolio may unlock new possibilities in the treatment of rare blood disorders.”. Breaking barriers in hemophilia: helping to evolv e the treatment paradigm. ePoster Abstract # OC48.2 ePoster Abstract # OC48.2

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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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The Pharma Data

SEPTEMBER 17, 2020

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. said Thomas Schinecker, CEO Roche Diagnostics.

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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

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

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

DECEMBER 11, 2020

All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic.

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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

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

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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

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

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The Pharma Data

MAY 12, 2021

New data and analyses to be presented from the pivotal Phase 3 CADENZA and CARDINAL studies of sutimlimab, a first-in-class investigational C1s inhibitor that has the potential to be the first approved treatment for hemolysis in adults with cold agglutinin disease (CAD), a serious and chronic autoimmune hemolytic anemia. Abstract-only.

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SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Cambridge, UK. Every day, Pfizer.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

JULY 21, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. for use in individuals 18 years of age and older.

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The Pharma Data

MAY 6, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

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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

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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Drug Discovery World

JANUARY 20, 2023

The HPX3002/HVTN 706, or ‘Mosaico’, Phase III clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America. Based on the DSMB’s recommendation, the study will be discontinued. The regimen was tested among men who have sex with men (MSM) and transgender people.

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Drug Discovery World

FEBRUARY 3, 2023

A recent four-month SUDV outbreak in Uganda that ended on January 11, 2023, caused 142 confirmed cases and 55 deaths. No treatment or vaccine for SUDV disease is licensed, although candidates are in clinical and preclinical trials.

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Drug Discovery World

FEBRUARY 6, 2023

It’s a rapid growth area for clinical trials in the next few years as we seek to understand the underlying biology behind many of the targets and diseases we study. For example, we noticed in a report that signal of the treatment effect in the data was not aligned with what would be expected.

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Drug Discovery World

FEBRUARY 2, 2023

A late-stage clinical trial in head and neck cancer for the treatment of severe oral blistering or oral mucositis caused by radiation therapy is planned. A late-stage clinical trial in head and neck cancer for the treatment of severe oral blistering or oral mucositis caused by radiation therapy is planned. Future Oncol.

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Drug Target Review

NOVEMBER 17, 2023

NK cells are among the front line of protection from infected and abnormal cells as part of the ‘innate immune response’. They recognise ‘cell stress molecules’ on the surface of infected, old, injured and cancerous cells without the need for complex pre-stimulation signals of the adaptive immune system (eg, T cells).

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