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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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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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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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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Drug Discovery World

JULY 3, 2023

From June 20-22, 2023, Cambridge Healthtech Institute hosted the seventh annual Immuno-Oncology Summit Europe in London.

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Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. We were there to present the latest findings from our research. MT: What’s next for STORM’s research? Results of that Phase I trial are expected to be presented later this year.

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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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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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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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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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XTalks

NOVEMBER 7, 2022

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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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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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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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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XTalks

MARCH 6, 2024

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. The week-long celebration is also a call to action for increased support and funding for neurological and psychological research.

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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

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

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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The Pharma Data

NOVEMBER 23, 2021

1 POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). Roche moment blazoned that new data from its expansive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021.

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Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The cell and gene therapy industry is no exception to this digital transformation.

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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. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. What is Flow Cytometry?

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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Drug Discovery World

NOVEMBER 16, 2022

DDW Editor Reece Armstrong learns about Molecular Devices’ Organoid Innovation Centre (OIC) and how the company is aiming to advance research into 3D biology and organoids. . 2D biology has been used by pharmaceutical researchers for decades. 2D vs 3D .

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The Pharma Data

MARCH 16, 2021

The test runs on widely used high-throughput systems and is for research purposes only. The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. 1.1.7), South Africa (B.1.351), 1.351), and Brazil (P.1). Variants of B.1.1.7, 1.351 and P.1

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The Pharma Data

APRIL 12, 2023

4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. A solution could be at hand with Overland Pharmaceuticals. Below is a roundup of some of this week’s interesting news.

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Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. In addition, to meet U.S.

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The Pharma Data

JUNE 26, 2021

The RECOVERY Actemra/RoActemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalised COVID-19 patients. The RECOVERY Actemra/RoActemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalised COVID-19 patients. Actemra/RoActemra has not been approved by the U.S.

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Drug Discovery World

JULY 22, 2022

As a result, researchers are striving to continually improve immuno-oncology approaches using the patient’s own immune cells to combat tumours. To mitigate these risks, clinicians are turning to other immunomodulators, such as cell-based therapies, bispecific antibodies, and cytokine treatments.

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Pharmaceutical Technology

SEPTEMBER 10, 2008

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. ” New projects we have been involved with have helped the company to accelerate its development in the field of pre-clinical research. Dr Ivana Surovà: Biotest s.r.o.

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Drug Discovery World

FEBRUARY 15, 2023

The first such research dates back to 1891, when William Coley attempted to inject heat-inactivated bacteria to treat osteosarcoma. This is an exciting field of cancer research which involves harnessing the body’s own immune system to target cancerous cells. This continues to be the standard of care.

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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.

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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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The Pharma Data

APRIL 23, 2021

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. Venclyxto combinations significantly improved complete response rates in people with newly diagnosed acute myeloid leukaemia in two key studies (VIALE-A and M14-358). The median OS was 14.7 months (95% CI: 11.9, months (95% CI: 7.4,

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Drug Discovery World

APRIL 11, 2024

The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research. Research highlights Blacksmith Medicines announced preclinical data on its oncology programme targeting flap endonuclease 1 (FEN1). And thanks to the city of San Diego for its hospitality.”

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The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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