Worldwide Clinical Trials

SEPTEMBER 29, 2022

For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. anti-human IgG).

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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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Pharmaceutical Technology

MARCH 31, 2023

Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra. Moreover, these events also have ramifications for planned clinical trials. The Sanofi vaccine contains an adjuvant, like Bimervax, to help strengthen the immune response to the vaccine.

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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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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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Clinical Trials Clinical Trials Trials Containment 52

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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Drug Discovery World

JANUARY 31, 2024

Vera Therapeutics has announced positive 72-week data from the open label extension (OLE) period of its Phase IIb ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN). In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN.

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Drugs Clinical Trials Clinical Trials Containment 52

pharmaphorum

FEBRUARY 24, 2022

Viral or bacterial infections, or airway irritants can damage lung cells, causing them to release damage associated molecular pattern (DAMP) molecules that attach to and activate the receptor for advanced glycation endproducts (RAGE) protein found on a cell’s membrane. said Cantex CEO Stephen Marcus.

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Drug Discovery World

SEPTEMBER 4, 2023

In August 2023, a study was conducted by Dr Soriful Islam, and Dr James Segars of the Johns Hopkins University School of Medicine and colleagues which found that in laboratory tests of human fibroid cells, EGCG reduced the amount of a compound that promotes cell division and the quantity of proteins responsible for the tumours’ fibrous contents 1.

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Drug Discovery World

JANUARY 11, 2024

Argininosuccinic aciduria is an inherited metabolic disorder that affects how the body breaks down protein – potentially leading to high levels of ammonia in the blood. mRNA contains instructions that direct the cells to make proteins.

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Research Gene Therapy RNA Gene 59

XTalks

MAY 24, 2022

The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Now, Gilead has replaced the material of the container vial with aluminosilicate glass, proving it to be a good material for storage and compatibility. “We to continue.

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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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XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The therapy’s strong clinical safety data helped Sarepta secure the approval, as among 85 patients, only 13 serious side effects and no deaths or discontinuations due to adverse events were reported.

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Gene Therapy Gene Protein FDA Approval 98

Drug Discovery World

SEPTEMBER 11, 2023

Both the diagnostic agent and therapeutic drug contain Ariceum’s proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC).

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Containment Clinical Trials Clinical Trials Production 59

Advarra

MARCH 10, 2023

Red blood cells contain hemoglobin, a protein that carries oxygen. hindering progress on SCD – there is also a lack of clinical trials and research. Diversity in Clinical Trials and SCD As many clinical trials in the U.S.

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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 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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Drug Discovery World

MARCH 3, 2023

So we wanted to examine if it would still work.” Mice lived longer or were cured Many ovarian tumours contain mesothelin, and the researchers tested three types of CAR molecule programmed to attack this particular protein. This can cause attacking T cells to be neutralised, which impairs the therapeutic effect.

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Protein Clinical Trials Clinical Trials Containment 52

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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Drug Discovery World

OCTOBER 21, 2022

The first and only oral contraception containing a new, synthetic version of a naturally occurring oestrogen has been launched in the UK. . Clinical study first step towards treating respiratory syncytial virus . First synthetic contraceptive pill launched in UK . New antibiotic could kill resistant pathogens .

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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

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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Drugs Clinical Trials Clinical Trials Containment 52

Pfizer

AUGUST 3, 2022

Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. mitogen activated protein kinase pathway, which demonstrated improvement in functional capacity (6-minute walk test; 6MWT) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM. Disclosure Notice.

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Development Vaccination Vaccine Production 101

pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

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Gene Therapy Gene Manufacturing Clinical Trials 93

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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XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

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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Drug Discovery World

JANUARY 19, 2023

A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint.

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Drugs Trials Clinical Trials Clinical Trials 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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XTalks

MAY 1, 2023

XTALKS WEBINAR: Patient-Centricity in Clinical Trials Sites — The Trinity of Patient, Sites and Sponsors Live and On-Demand: Monday, June 12, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how the Patient Concierge program increases study participants’ engagement and decreases dropout.

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FDA Approval Gene Genetics Protein 89

pharmaphorum

SEPTEMBER 14, 2021

The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the ‘repeatome’, that could contain targets for cancer and autoimmune disorders.

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The Pharma Data

DECEMBER 15, 2020

Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC ® Discovery Engine, today announced the pricing of an underwritten public offering of 5,714,286 shares of its common stock at a price of $70.00 NEW HAVEN, Conn., Forward-Looking Statements.

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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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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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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

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