Worldwide Clinical Trials

JUNE 21, 2024

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

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Scienmag

OCTOBER 9, 2020

Cross-reactive neutralization of SARS-CoV-2 by serum antibodies from recovered SARS patients and immunized animals Antibodies in serum samples collected from patients infected with SARS-CoV during the 2003 outbreak effectively neutralized SARS-CoV-2 infection in cultured cells, according to a new study.

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XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. The antibodies are conjugated to fluorochromes for them to be detected. What is Flow Cytometry?

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XTalks

JANUARY 6, 2021

Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. Nanobodies are about a quarter of the size, and approximately one tenth of the weight, of a typical human antibody. TJ” Esparza, BS, and David L.

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The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. Alloy’s first platform, the ATX-Gx(TM) mouse platform, is a suite of transgenic mice designed for best-in-class in vivo discovery of fully human monoclonal antibodies.

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Pharmaceutical Technology

FEBRUARY 28, 2023

Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma and Shenzhen Chipscreen Biosciences’ holding subsidiary Chipscreen NewWay Biosciences have entered an exclusive licensing agreement for YH008, a bispecific antibody. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. before expanding it into Europe.

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XTalks

DECEMBER 28, 2023

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Nipocalimab is an investigational monoclonal antibody that targets the neonatal Fc receptor. This test can be performed as early as the tenth week of pregnancy.

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BioSpace

FEBRUARY 16, 2021

the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several s. In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D.,

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The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. months, 39.4%

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The Pharma Data

APRIL 7, 2021

Anti-p53 antibodies are antibodies that mistakenly target a patient’s own tissues, leading to a growth of solid tumors. today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. The assay is now available for all markets accepting the CE Mark.

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XTalks

MARCH 1, 2021

The third dose will be administered to the participants regardless of antibody titer levels. After the third dose, antibody levels will be assessed at the time of the third dose, and then one week and one month thereafter. The third booster will be given to participants from the Phase I study in the US.

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The Pharma Data

OCTOBER 14, 2021

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).

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pharmaphorum

DECEMBER 1, 2022

Exploring the implementation of complex in-vitro models for drug development. The pharmaceutical industry globally is realising the growing potential of in vitro tissue models for drug discovery, pathology modelling and validation, safety and toxicity. Billion by 2028. Billion by 2028. Event Hashtag: #3DCellCulture2023.

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pharmaphorum

MARCH 1, 2021

The test is the result of Roche’s collaboration with South Korean in-vitro diagnostic company SD Biosensor, which has also resulted in two antigen tests for use by healthcare professionals and an antibody test that can detect if a person has been infected with SARS-CoV-2 in the past.

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FDA Law Blog

SEPTEMBER 27, 2022

The program is currently not accepting applications for antibody tests (HPM has blogged previously about FDA’s Monkeypox Policy here ). The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

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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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Protein Vaccine Vaccination Antibody 52

XTalks

JANUARY 27, 2021

The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S.

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The Pharma Data

JANUARY 6, 2021

Studies Show Cyto-111 Enables Delivery of Antibodies to Previously Inaccessible Intraneuronal Targets without the need for a Viral Vector or Transfection. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. NEW YORK, Jan.

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Medicine Antibody Protein In-Vitro 52

FDA Law Blog

DECEMBER 13, 2022

Javitt & Jeffrey N. Gibbs — It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here ). This is not a trivial matter. Telehealth has become increasing important to the health care system. Emphasis added).

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The Pharma Data

AUGUST 31, 2020

Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate.

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The Pharma Data

JANUARY 19, 2021

Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

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Roots Analysis

NOVEMBER 30, 2021

Most of the facilities are providing in vitro bioassay services for cell and gene therapies. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.

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The Pharma Data

OCTOBER 14, 2021

Roche today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). Roche’s Chief Medical Officer and Head of Global Product Development.

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BioSpace

JUNE 16, 2022

The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.

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XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. 1.351, offers much-needed reassurance, as does its durability over a period of at least six months.

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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. days quicker compared to placebo. days; 95% C.I, days compared to placebo [5.7

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XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. A positive result on the test indicates a high likelihood of amyloid presence, as confirmed by amyloid PET scans or cerebrospinal fluid (CSF) testing.

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The Pharma Data

NOVEMBER 15, 2020

Diadem has taken steps to patent the innovative AlzoSure technology, including its proprietary antibody and the actual process for the assay. . “Alzheimer’s disease and other dementias afflict more than 50 million people worldwide. ” Diadem also provided an update on its intellectual property. en/homepage/.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Function Dictates Regulation It’s essential to understand how the product interacts with a patient, as well as what level of importance it holds to the patient’s health.

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