Pharmaceutical Technology

MAY 24, 2023

is expected to enter Phase II/III registration trial as the first-line treatment for advanced Merkel cell carcinoma (MCC) early next year. to investigational new drug-enabling trials, expected in 2024, to treat aggressive diffuse large B-cell lymphomas (DLBCLs). Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

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Gene Therapy In-Vivo In-Vitro Immune Response 130

The Pharma Data

JUNE 17, 2022

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The two antibodies also were fully active against Alpha, Beta, Gamma, and Delta variants. 2 subtypes.

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Antibody In-Vivo In-Vitro Immune Response 52

pharmaphorum

OCTOBER 5, 2022

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

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Antibody In-Vitro Radiology Development 110

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.

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Antibody Licensing Licensing In-Vitro 52

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours.

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Antibody Immune Response Production Engineer 52

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Monoclonal antibodies (mAbs). Somatic cells. Gene and cellular therapies. Recombinant therapeutic proteins. Growth factors. Fusion proteins. Interferons.

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XTalks

MARCH 1, 2021

NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials. Pfizer Inc.

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Vaccine Vaccination Development In-Vitro 111

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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Antibody Licensing Licensing Development 52

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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Antibody In-Vitro Trials Development 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo.

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Trials Antibody Vaccination Vaccine 52

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccine Vaccination Trials Clinical Trials 59

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Antibody In-Vivo Medicine Vaccination 52

Pharmaceutical Technology

SEPTEMBER 10, 2008

IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo. Natalie Coomber: Can you provide a quick background on the history of Biotest and the main work it is currently undertaking?

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In-Vitro Genotoxicity In-Vivo Development 100

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. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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Antibody Clinical Trials Clinical Trials Manufacturing 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

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Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset. In both PROVENT and Paraphernalia, AZD7442 was generally well permitted.

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Trials Antibody In-Vitro Vaccination 52

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. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.

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Antibody Medicine In-Vitro Trials 52

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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Trials Antibody In-Vitro Medicine 52

Delveinsight

JANUARY 12, 2021

It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. million after Birinapant successfully becomes a part of the Phase I trials. million after Birinapant successfully becomes a part of the Phase I trials.

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Licensing Licensing Antibody Gene Therapy 52

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%

Antibody 52

Antibody In-Vitro Medicine Engineer 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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Clinical Trials Clinical Trials Trials Production 52

The Pharma Data

JANUARY 17, 2021

The year is starting to pick up in terms of clinical trial announcements. After a single vaccination, neutralizing antibodies against COVID-19 were observed in more than 90% of volunteers at Day 29 and 100% of the volunteers between the ages of 18 and 55 at Day 57. Here’s a look at last week’s news. COVID-19-Related.

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Immune Response Antibody Trials Clinical Trials 52

XTalks

MARCH 11, 2021

After its identification in late 2019, COVID-19 was officially declared a pandemic by the World Health Organization (WHO) on March 11, 2020. On the one-year anniversary of the COVID-19 pandemic, there is much to reflect on. As of March 11, 2021, COVID-19 has claimed the lives of over 2.6 million people worldwide. COVID-19 Treatments.

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Vaccination Vaccine In-Vitro Antibody 98

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 Vaccination Vaccine Antibody 52

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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Antibody Trials Vaccination Vaccine 52

The Pharma Data

NOVEMBER 12, 2021

COMET-TAIL Phase III data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations The trial enrolled participants during the Delta variant wave of the pandemic in the US. In the IM administration (500 mg) arm of the trial, there was a2.7

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Trials In-Vitro Antibody Clinical Development 40

The Pharma Data

NOVEMBER 17, 2021

Nasdaq VIR) moment blazoned US government contracts totalling roughly$ 1 billion (1) (USD) to buy sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Exigency Use Authorization (EUA) in May 2021. 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

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Antibody In-Vitro Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 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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Vaccination Vaccine In-Vitro Protein 52

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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In-Vitro Antibody Medicine Clinical Trials 52

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; 95% C.I,

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Clinical Trials Clinical Trials Trials In-Vivo 40

The Pharma Data

JANUARY 19, 2021

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. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).

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In-Vitro Production Trials Manufacturing 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

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Trials Allergies In-Vitro Antibody 52

The Pharma Data

NOVEMBER 23, 2021

Vital results from the phase I/ II GO29781 study, presented for the first time and featured in the ASH press programme, showing mosunetuzumab, a CD20xCD3 T- cell engaging bispecific antibody immunotherapy, achieved high response rates with a manageable safety profile. The safety profile was similar for Polivy plus R-CHP versus R-CHOP.1

Antibody 52

Antibody In-Vitro Development Genome 52

XTalks

NOVEMBER 15, 2023

The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. According to the agency, the virus is found primarily in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas where the virus-carrying mosquitos are endemic.

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FDA Approval Vaccination Vaccine In-Vitro 59