XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 Glenn, president of research and development at Novavax, in a news release. “It

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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The Pharma Data

AUGUST 15, 2021

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. Although the first vaccines to receive Emergency Use Authorization by the U.S.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods?

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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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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.

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Advarra

MARCH 10, 2023

Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

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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

OCTOBER 21, 2022

However, there was also controversy as researchers faced a backlash from the National Institute of Allergy and Infectious Diseases for their study which created a hybrid version of Covid-19. . Boston researchers criticised over creation of Covid-19 variant . Clinical study first step towards treating respiratory syncytial virus .

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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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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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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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Pfizer

AUGUST 3, 2022

Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. We thank the patients, families, investigators and members of the advocacy community who contributed to this research,” said Chris Boshoff, M.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

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XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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WCG Clinical

NOVEMBER 17, 2023

Originally released in 1976, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) serve as the foundation of biosafety-focused oversight of research involving recombinant or synthetic nucleic acids (rsNA). Since then, however, certain genetic engineering technologies (e.g.,

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XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. AstraZeneca, a UK-based global pharmaceutical company, is leading the COVID-19 trial as a regulatory sponsor. Fauci, in a statement.

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XTalks

MAY 1, 2023

While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. Attendees will explore how Virtual Research Coordination (VRCC) can help with attracting a more diverse patient population, and more. How Does Qalsody Work?

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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. President of Research and Development, Novavax. Data from the event-driven trial could support global authorization and approval, including in the U.S.

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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. Some research has suggested systemic administration of AAV vectors can cause damage to liver cells and inflammation.

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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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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

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. It’s an exciting area,” he told The Guardian.

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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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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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XTalks

JANUARY 5, 2021

In other research areas, innovations in the pharmaceutical, medical device and biotech industries will benefit from approaches such as artificial intelligence (AI) and increased digitization. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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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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Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples.

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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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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. TAK-019 Clinical Trial.

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XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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The Pharma Data

DECEMBER 13, 2020

The DSMB indicated that the Phase III clinical study should continue without modifications. “We are pleased with the DSMB recommendation that the Phase III clinical trial continues without any protocol modification,” said Frank Weber, MD, CMDO of Polyphor. ALLSCHWIL, Switzerland, Dec. ALLSCHWIL, Switzerland, Dec.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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Pfizer

FEBRUARY 9, 2023

The gE protein is important for viral replication and the cell-to-cell spread after reactivation of the virus in the nerve cells. Pfizer Disclosure Notice The information contained in this release is as of February 10, 2023. 3 Pfizer and BioNTech announced a shingles vaccine collaboration in January 2022.

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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. and CHENGDU, China , Feb.

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XTalks

JANUARY 27, 2021

The study was conducted in collaboration with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). “As The two variants studied have mutations in the spike protein of SARS-CoV-2, with 17 mutations in B.1.1.7 1.351 variant.

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The Pharma Data

NOVEMBER 17, 2021

2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 3,4,5,6,7). .”

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