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

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

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The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

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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

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. And safety outcomes were similar in the REGN-COV2 dose groups and the placebo group.

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The Pharma Data

JANUARY 22, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.”. Martin Berman-Gorvine.

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The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. It is now in a Phase I/IIa trial for adult NSCLC with EGFRex20ins mutations.

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. The Novavax jab is only the second to enter large scale trials in the UK; the other has been developed by the University of Oxford.

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. Preliminary results from that trial are expected in the third quarter ( DID , March 15 ). ? 14, 2020 ). Jason Scott. Source link.

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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. . Moderna started a large-scale Phase 3 trial last month that will test the vaccine’s safety and effectiveness on 30,000 people with results expected in October.

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The Pharma Data

AUGUST 6, 2020

Under the pact, AZ will transfer the vaccine’s technology to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.

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Drug Discovery World

JULY 17, 2023

Unravelling the influence of these gut bacteria—commonly referred to as the bacterial gut microbiome—on drug response and immune response will bring fundamental changes to how we approach drug discovery and development, as well as patient care. REFERENCES Rosshart, S. Science (80-. ). 365, (2019) .

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The Pharma Data

OCTOBER 14, 2021

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Immune response was measured using immunoglobulin G (IgG) assays. Using data from the MS PATHS network in the U.S.,

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PLOS: DNA Science

OCTOBER 12, 2023

Can they deliver healing genes without triggering an overactive immune response? The details are disturbingly reminiscent of the famous case of Jesse Gelsinger , who died from a ferocious immune response to experimental gene therapy in September 1999. An immune response is two-tiered.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. ” Dr.

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The Pharma Data

JULY 6, 2021

Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. FDA for ITP.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% The CDD will sponsor and manage KWF-supported trials.

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Drug Target Review

JANUARY 15, 2024

Onchilles Pharma has translated this breakthrough research into a proprietary set of therapeutics and plans to start first-in-human clinical trials for its first programme, N17350, in 2024 in skin cancers, head and neck cancer, and triple-negative breast cancer. 2021 May 7;0(0). Reference 1. Cui C, Chakraborty K, Tang XA, et al.

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Drug Discovery World

APRIL 20, 2023

SARS-CoV-2 particles spread through the respiratory mucosa and other infected cells, causing changes in peripheral immune cells and eliciting a cascade of immune responses, resulting in a detrimental cytokine storm. 2021, doi: 10.1038/ s41598-021-92045-x. 2021, doi: 10.1016/j.eclinm.2021.101019. S Bliddal et al.,

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Drug Discovery World

FEBRUARY 13, 2023

Diseases ranging from cancer to viral immune response, from cardiovascular to reproductive health, and from metabolic to nervous systems all have the potential to benefit from in-depth transcriptomics. DDW: Can RNA profiling be used past the point of early development to monitor how drugs perform within clinical trials?

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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. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. Results of the Phase 2 trial will inform the Phase 3 protocol.

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The Pharma Data

JANUARY 20, 2021

20, 2021 /PRNewswire/ — INOVIO Pharmaceuticals, Inc. The offering is expected to close on or about January 25, 2021 , subject to customary closing conditions. PLYMOUTH MEETING, Pa. , This offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement.

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The Pharma Data

DECEMBER 8, 2020

With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer. “We

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The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. Jason Scott. Source link.

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The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and Australia. About Matrix-M.

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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

MAY 12, 2021

New data to be featured at EHA 2021 Congress highlight Sanofi’s ongoing commitment to rare blood disorders. Additional data to be shared on rilzabrutinib, an investigational, peripheral Bruton’s tyrosine kinase (BTK) inhibitor with Tailored Covalency ® technology intended to treat immune thrombocytopenic purpura (ITP).

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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The Pharma Data

JANUARY 12, 2021

Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immune response. . “It It is a new immune checkpoint that is expressed on three different immune cells: Macrophages, [Natural Killer] NK cells, and T cells. [It]

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.

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The Pharma Data

APRIL 8, 2021

AstraZeneca will share updates from the Company’s innovative early oncology pipeline across multiple strategic platforms during the virtual American Association of Cancer Research (AACR) Annual Meeting, 10 to 15 April 2021. A pooled analysis of interstitial lung disease data in patients treated with Enhertu across eight cancer trials.

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The Pharma Data

JANUARY 21, 2021

The 2021 trend of biotech initial public offerings (IPOs) continued this week. The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). On January 5, 2021, the U.S. Here’s a look. Precigen – Germantown, Md.-based million IPO at a price of $7.50

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The Pharma Data

JANUARY 25, 2021

25, 2021 — Giving melanoma patients a “personalized” vaccine can prompt an anti-tumor immune response that lasts for years, an early study finds. But it builds on earlier work showing it is possible to spur the immune system to respond to an individual’s unique tumor. 21, 2021, online.

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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

SEPTEMBER 8, 2021

The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.

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The Pharma Data

JANUARY 3, 2021

This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021.

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