The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces. bioRxiv [Preprint].

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The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc. Disclaimer.

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Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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XTalks

JANUARY 3, 2024

In individuals affected by ATTR, which includes both hereditary and wild-type (non-hereditary) variants, the TTR protein forms fibrils that accumulate in various tissues. Safety and Efficacy of Wainua The FDA’s approval of Wainua is underpinned by compelling clinical data. This conjugation facilitates ASO delivery to hepatocytes.

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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 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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pharmaphorum

SEPTEMBER 14, 2020

While there may be just under 20,000 confirmed protein coding genes, it turns out that much of the genome outside of these genes is also important in regulating how the genome is controlled. Genomics also means we will be able to stratify patients, based upon their genomic makeup, to make clinical trials much more efficient and targeted.

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The Pharma Data

JANUARY 7, 2021

HER2/ neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. GP2 is a 9 amino acid transmembrane peptide of the HER2/ neu protein.

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Containment Clinical Trials Clinical Trials Protein 52

XTalks

SEPTEMBER 8, 2020

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. The genetic material contains SARS-CoV-2 spike protein.

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pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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The Pharma Data

SEPTEMBER 14, 2020

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). The move follows a green light by the UK's MHRA. Source link.

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XTalks

JULY 1, 2021

The name contains two syllables, the first referencing the spike protein of SARS-CoV-2, and the second a short-form of the word “vaccine.”. “At However, the groundwork was laid in April of that year, shortly after clinical trials of the Pfizer-BioNTech vaccine began.

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The Pharma Data

NOVEMBER 9, 2020

Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. and globally.”.

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The Pharma Data

JANUARY 13, 2021

Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties. Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”.

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pharmaphorum

JANUARY 3, 2023

SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. The clinical trial participants will be evaluated as part of a long-term study over 15 years.

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The Pharma Data

JANUARY 13, 2021

HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells. Dose escalation for HPN217 in the Phase 1/2 clinical trial is progressing rapidly. NYSE: ABBV).

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XTalks

AUGUST 7, 2023

He also thanked the 500 patients, caregivers, investigators and healthcare professionals involved in the Phase III trials and stated that Verrica’s commercial team is actively preparing for the product’s commercial launch in September 2023. Participants in these trials ranged in age from two to 60, with a median age of six.

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Trialfacts

MARCH 7, 2025

This study offers a simple blood test to detect an abnormal protein associated with Alzheimers disease in adults aged 65 to 80. The majority of participants (about 96%) will not have this abnormal protein and will not progress further in the study. Participants may receive a new study medication for early Alzheimers at no cost.

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The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. FORWARD LOOKING STATEMENT. References. Nat Commun 12, 288 (2021).

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Pfizer

SEPTEMBER 28, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . The information contained in this release is as of September 28, 2022. . • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. .

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XTalks

MAY 15, 2023

Protalix BioTherapeutics focuses on the production, development and commercialization of recombinant therapeutic proteins. He also highlighted that the development of Elfabrio marked a significant milestone in the quest for a durable therapy for Fabry disease, supported by promising results from clinical trials.

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The Pharma Data

JANUARY 20, 2021

HER2/ neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. GP2 is a 9 amino acid transmembrane peptide of the HER2/ neu protein.

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XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. islet cells of the organ, giving rise to the disease.

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D.,

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The Pharma Data

OCTOBER 14, 2020

is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA.

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The Pharma Data

JANUARY 29, 2021

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks. 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.

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The Pharma Data

JANUARY 29, 2021

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks. 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.

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

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