Drug Patent Watch

DECEMBER 9, 2024

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. Biosimilar Series Part I: Overcoming Statistical Challenges in Trials. National Center for Biotechnology Information.

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Pharmaceutical Technology

FEBRUARY 6, 2023

Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. Feinstein Institutes president and CEO Kevin Tracey said: “The first step in drug discovery is identifying molecular targets. “Dr

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XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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Research Dermatology Clinical Trials Clinical Trials 105

World of DTC Marketing

DECEMBER 29, 2020

Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.

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Vaccination Vaccine Development Clinical Trials 307

pharmaphorum

APRIL 12, 2021

Exscientia was the first company to start human trials of a new drug designed using artificial intelligence (AI) last year, and now says it has started testing of the first AI candidate for immuno-oncology. . Exscientia will lead the clinical development of the A2A drug, with Evotec retaining co-ownership rights.

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Trials Clinical Trials Clinical Trials Immune Response 127

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. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

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XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025. Polyrizon’s partnerships further strengthen its R&D capabilities.

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Drug Delivery Drugs Immune Response Allergies 111

pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

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Pharmaceutical Technology

JUNE 16, 2023

Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients. Avenge Bio is currently adding patients in an ongoing Phase I/II trial investigating AVB-001 to treat refractory ovarian cancer.

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Drugs Immune Response Clinical Development Trials 130

XTalks

DECEMBER 30, 2024

has announced promising Phase IIb results for cenerimod, an investigational drug targeting immune system dysfunction in moderate-to-severe systemic lupus erythematosus (SLE). SLE is an autoimmune disease where the immune system attacks healthy tissues, causing inflammation, pain and potential organ damage. Viatris Inc.

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Pharmaceutical Technology

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years.

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Scienmag

JANUARY 26, 2022

WHAT: In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The […]. (..)

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Pharmaceutical Technology

JULY 12, 2022

Health Canada has accepted to review Arcutis Biotherapeutics’ New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adult and adolescent patients. A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses. versus a vehicle rate of 6.1%

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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.

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Pharmaceutical Technology

OCTOBER 6, 2022

Ramatroban will be analysed in a placebo-controlled, randomised Phase II/III RAMBAN-1 clinical trial. To be carried out at several study sites in India, the trial is anticipated to back an emergency use authorisation from regulatory agencies in the country for acute Covid-19. .

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Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Flow cytometry (FCM) is the primary method scientists use to monitor immune responses in clinical trials, primarily because of its power, speed, and ability to provide a comprehensive view of a disease’s macro-environment.

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Camargo

JULY 27, 2021

When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.

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Pharmaceutical Technology

NOVEMBER 20, 2022

The latest development was based on findings from a Phase II clinical trial of the vaccine in South Africa as well as from the Phase III Prevent-19 trial in the US and Mexico. Healthy adult subjects were inoculated with a booster dose of the vaccine nearly six to 11 months following their initial two-dose regimen in the trials.

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XTalks

NOVEMBER 12, 2024

Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies. These therapies work by controlling excessive inflammatory responses in the lungs.

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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. It has been developed using the company’s recombinant nanoparticle technology.

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The Pharma Data

MAY 17, 2021

The drug companies had hoped to have regulatory approval for their jab in the first half of this year, but interim results from a Phase 1/2 study, released in December 2020, had shown an “insufficient” ? response in the over-50s, the age group deemed at higher risk for contracting the severe form of the virus. .

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Pharmaceutical Technology

AUGUST 18, 2022

The company sought expanded provisional approval for the booster shots based on findings from its Phase II clinical trial carried out in Australia, another Phase II trial in South Africa and the COV-BOOST trial sponsored by the UK. Furthermore, the occurrence of Grade 3 or higher events was found to be comparatively low.

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XTalks

NOVEMBER 12, 2024

Research is focused on discovering biomarkers for early detection, developing new drug therapies and exploring immunotherapy options to help the body’s immune system recognize and attack cancer cells. Targeted therapies and clinical trials also offer potential treatment avenues for those diagnosed with the disease.

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Research FDA Approval Trials Clinical Trials 105

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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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

NOVEMBER 25, 2021

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). The post Trial of intranasal Alzheimer’s vaccine gets underway in US appeared first on.

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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.

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FDA Approval Immune Response Antibody Marketing 52

XTalks

MAY 4, 2023

As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments. How does Beyond Celiac spread awareness about research and clinical trials for celiac disease?

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Clinical Trials Clinical Trials Trials Immune Response 98

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.

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pharmaphorum

JANUARY 6, 2023

The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.

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Worldwide Clinical Trials

JUNE 21, 2024

Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline. Interested in hearing more insights from Matt?

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pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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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

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.

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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

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

World of DTC Marketing

AUGUST 3, 2020

QUICK READ: As COVID-19 vaccines enter Phase III trials one has to wonder just how transparent pharma companies will be with the data. What we have right now is a collection of animal data, immune response data, and safety data based on early trials and from similar vaccines for other diseases.

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