Pharmaceutical Technology

JANUARY 9, 2023

AbbVie has entered a global collaboration and option agreement with Immunome to discover new antibody-target pairs for cancer treatment. The multi-year collaboration will use Immunome’s Discovery Engine to discover up to ten new antibody pairs arising from three specified types of tumours.

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Engineer Antibody Drugs Immune Response 130

Worldwide Clinical Trials

OCTOBER 14, 2024

Scientists now use cutting-edge techniques, including biological therapies that target specific immune system components and precision medicine approaches that personalize treatment plans based on a patient’s genetic profile.

Research 147

Research Clinical Trials Clinical Trials Immune Response 147

Worldwide Clinical Trials

OCTOBER 14, 2024

Scientists now use cutting-edge techniques, including biological therapies that target specific immune system components and precision medicine approaches that personalize treatment plans based on a patient’s genetic profile.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

Pharmaceutical Technology

OCTOBER 25, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), a kind of liver cancer. Imjudo is also a human monoclonal antibody and hinders cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) activity.

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Protein Immune Response Antibody FDA Approval 173

XTalks

DECEMBER 20, 2024

The US Food and Drug Administration (FDA) has approved Celltrions Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for the treatment of several immune-mediated diseases. By blocking these inflammatory pathways, it helps manage overactive immune responses in conditions like psoriasis and Crohns disease.

FDA Approval 52

FDA Approval Immune Response Antibody Marketing 52

Pharmaceutical Technology

MAY 12, 2023

The collaboration will use the integrated drug creation platform of Absci and the clinical immunology datasets from the Kennedy Institute to identify antibodies to immune-mediated inflammatory diseases and autoimmune conditions with unprecedented speed.

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Development Antibody Immune Response Genome 130

pharmaphorum

JULY 5, 2021

The number of positive cases per 100,000 people, yes/no results on PCR tests, absence or presence of antibodies – these have set the benchmarks used to determine when we can open our schools and restaurants, remove our masks and resume something resembling our old routines. As the U.S.

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Immune Response Antibody Vaccination Vaccine 105

Pharmaceutical Technology

DECEMBER 16, 2022

The example of rituximab, originally a cancer drug, now used for lupus, has shown the potential of adopting cancer medications for lupus. Furthermore, drug-free remission was maintained during longer follow-up and even beyond the reappearance of B cells.

Immune Response 147

Immune Response Marketing Antibody Trials 147

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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Antibody Clinical Trials Clinical Trials In-Vitro 162

Pharmaceutical Technology

MAY 19, 2023

OncoResponse has secured a $13m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and raised an additional $14m in funding from investors for advancing OR502 to investigational new drug (IND) and clinical trials. It is planned to enter clinical studies this year. ”

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Immune Response Clinical Trials Clinical Trials Antibody 130

pharmaphorum

JUNE 16, 2021

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. 37% of the standard care group deteriorated to that point, compared to 30% of those on Regeneron’s drug.

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Antibody Drugs Immune Response Trials 98

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19. Regeneron Pharmaceuticals Inc.’s

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Antibody Immune Response Trials Clinical Trials 75

STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response. Happy holidays from all of us.

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FDA Approval Immune Response Drugs Research 98

NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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Immune Response Vaccination Vaccine Antibody 62

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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Antibody Trials Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. They looked at safety as well as carrying out a futility analysis to gauge whether the drug was working as expected.

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Drugs Antibody Contract Manufacturing Immune Response 97

Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. THN391 binds the inflammation-driving component of fibrin, known for activating the immune responses in neurodegenerative and ophthalmologic diseases.

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Development Immune Response Clinical Trials Clinical Trials 130

pharmaphorum

JULY 6, 2021

It also said that the tumour response was aligned to the level of HER2-targeting antibodies generated by the vaccine, which is given as three doses over a 35-day period. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

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Vaccination Vaccine Trials Antibody 119

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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Antibody Trials Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. In January 2022, the vaccine was approved by KFMDS as a primary series in adults aged 18 and above.

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Vaccination Vaccine Immune Response Protein 147

Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report. Buy the report here.

Immune Response 130

Immune Response Development Clinical Trials Clinical Trials 130

pharmaphorum

JUNE 28, 2022

billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. Astellas has agreed a $1.36 The alliance includes an upfront payment of $90 million, backed by $422.5

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Antibody Immune Response Gene Therapy Drugs 105

Pharmaceutical Technology

MAY 17, 2023

The treatment is an investigational first-in-class monoclonal anti-human complement factor C5a antibody. It has been designed for controlling the complement factor C5a, which is a protein that plays an important and harmful role in the immune response of the body.

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Manufacturing Immune Response Protein Antibody 130

pharmaphorum

DECEMBER 17, 2020

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. EUSA Pharma bought global rights to the drug from Janssen in $115 million. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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Drugs Immune Response Trials Clinical Trials 105

pharmaphorum

OCTOBER 11, 2022

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immune response to the virus. “The authors acknowledge certain limitations of the study, including small numbers of participants.

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Vaccination Vaccine Immune Response Development 116

Pharmaceutical Technology

AUGUST 18, 2022

According to the findings, a third dose induced greater immune responses similar to or surpassing levels linked to protection in Phase III trials. Nuvaxovid vaccine elicited a substantial antibody response when administered as a heterologous third booster dose in the COV-BOOST trial.

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Immune Response Vaccination Vaccine Protein 130

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing 161

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Vaccination Vaccine Trials Immune Response 98

XTalks

AUGUST 8, 2022

MiroBio is a private biotech company based in the UK that focuses on developing checkpoint agonist antibodies, which are a new class of therapies that work to restore immune balance in patients with autoimmune and inflammatory diseases. PD-1 is a potent immune inhibitory receptor. MiroBio’s Research Pursuits.

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Immune Response Antibody Life Science Engineer 98

pharmaphorum

MAY 11, 2021

Flagship Pioneering, the VC fund run by Moderna’s co-founder Noubar Afeyan has launched a new biotech Laronde , with an ambitious plan to create a new class of drugs based on Endless RNA. The technology is designed to replace antibodies, which have become standard therapy in many diseases but are complicated and expensive to manufacture.

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RNA Drugs Protein Immune Response 98

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8

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FDA Approval Antibody Immune Response Drugs 97

pharmaphorum

JANUARY 12, 2021

For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens. There are other theoretical advantages as well.

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Licensing Licensing Vaccination Vaccine 119

The Pharma Data

SEPTEMBER 14, 2020

Illustration of antibodies attacking the coronavirus. A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus. What are monoclonal antibodies?

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Antibody Trials Immune Response Vaccination 52

XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US.

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Insulin Drugs FDA Approval Immune Response 97

pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

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Antibody Immune Response Development Medicine 105

pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs. Sutimlimab, which Sanofi acquired via its $11.6

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Drugs Immune Response Development Antibody 96

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

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Antibody Immune Response Radiology Marketing 102