Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. Results of that Phase I trial are expected to be presented later this year. OR: The presentations at ESMO TAT 2024 highlighted our advances in targeted and more personalised anti-tumour therapies.

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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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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

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. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).

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Delveinsight

JANUARY 12, 2021

Thus, the drug appears to be a promising therapeutic agent in treating different forms of cancer in combination with other drugs. IGM-8444 is another drug that is currently being tested in a phase I dose-escalation study in patients with solid and hematologic malignancies by IGM Biosciences.

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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

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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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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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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XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.

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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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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). The primary distinctions between biologics and small molecule drugs are their size, their structural complexity, and the way in which they are produced.

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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

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity.

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XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

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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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Drug Discovery World

FEBRUARY 16, 2024

New drug discovery and development concepts The event started with a panel discussion on new drug discovery and development concepts and tools in cancer research. Another factor he mentioned is that drug development is focused on an efficacy versus effectiveness problem, which Rombotis also mentioned.

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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? Not yet, according to Ewart.

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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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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. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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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

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Drug Discovery World

NOVEMBER 16, 2022

In April 2021, life sciences solutions provider Molecular Devices launched its Organoid Innovation Centre (OIC), an initiative designed to help scientists leverage the potential of 3D biology throughout the drug discovery process. . 2D vs 3D . 2D biology has been used by pharmaceutical researchers for decades. 2D vs 3D .

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The Pharma Data

SEPTEMBER 1, 2020

Food and Drug Administration (FDA). 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.

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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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XTalks

MARCH 2, 2021

As the US Food and Drug Administration (FDA) handed out an emergency use authorization (EUA) to Janssen’s COVID-19 vaccine over the weekend — making it the third authorized COVID-19 vaccine in the US — many people became laser-focused on the 66 percent average efficacy of the single-dose shot.

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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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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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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials.

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The Pharma Data

NOVEMBER 11, 2021

”People with COVID-19 across Europe are formerly being treated with Ronapreve grounded on exigency authorisations that followed the CHMP’s scientific opinion before this time, and we ’re pleased that the commission has now recommended the blessing of the antibody combination.” It has also been conditionally recommended by WHO.

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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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Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In addition, to meet U.S. and around the world.

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The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement.

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The Pharma Data

JUNE 26, 2021

Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. FDA in this setting, but the U.S.

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The Pharma Data

NOVEMBER 12, 2021

About Ronapreve (casirivimab and imdevimab) The efficacity and safety of Ronapreve (casirivimab and imdevimab, known as REGEN-COV ® in the United States) have been studied across multiple phase III clinical trials innon-hospitalised and hospitalised COVID-19 cases, and in the preventative setting.

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