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

DECEMBER 16, 2022

The rheumatology market is a rapidly growing and highly lucrative industry, but there are still major untapped opportunities for cellular therapies to enter this space, in particular the systemic lupus erythematosus (SLE) market.

Immune Response 147

Immune Response Marketing Antibody Trials 147

BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

Immune Response 105

Immune Response Vaccination Vaccine Trials 105

BioPharma Reporter

NOVEMBER 9, 2020

Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics.

Immune Response 121

Immune Response Regulation Marketing 121

XTalks

DECEMBER 20, 2024

Importantly, patients switching from Stelara to Steqeyma maintained stable anti-drug antibody (ADA) levels, demonstrating consistent immune responses to the drug over time. 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

SEPTEMBER 14, 2022

Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.

Immune Response 246

Immune Response In-Vivo Production Manufacturing 246

pharmaphorum

FEBRUARY 25, 2021

A nasal delivery method will also produce an immune response at the point where the virus enters the body. Professor Sarah Gilbert, who formed the University of Oxford team that developed the vaccine marketed by AstraZeneca, pointed out to the UK’s Commons Science and Technology Committee that there is already a nasal vaccine for flu.

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

Pharmaceutical Technology

MARCH 20, 2023

The collaboration, under a sponsored research agreement, will focus on mRNA vaccines that can help in modulating the normal immune response of the body for the treatment of certain autoimmune diseases as well as allergic conditions.

Vaccination 245

Vaccination Vaccine Development Allergies 245

BioPharma Reporter

SEPTEMBER 14, 2021

Johnson & Johnson says data published in The Lancet on its Ebola vaccine regimen shows it has a robust and durable immune response in adults and children.

Vaccination 93

Vaccination Vaccine Immune Response Regulation 93

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

Vaccination 130

Vaccination Vaccine Protein Immune Response 130

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences research executive vice-president Flavius Martin stated: “The team at XinThera has developed research assets with the potential to target the DNA damage repair pathway in treating cancer and direct the body’s immune response in inflammatory diseases, both of which may improve outcomes for people living with these diseases.

Immune Response 130

Immune Response DNA Clinical Trials Clinical Trials 130

Medical Xpress

JANUARY 25, 2023

A new COVID-19 vaccine based on a different platform than current vaccines on the market has been tested in humans for the first time by researchers at Radboud university medical center. Administration of this vaccine in healthy study participants was well tolerated and led to a good immune response.

Vaccination 80

Vaccination Vaccine Immune Response Marketing 80

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

Pharmaceutical Technology

AUGUST 26, 2022

A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) Japan also approved a vaccine in July 2022, marketed by KM Biologics Co (Kumamoto, Japan). See Table 1).

Vaccination 130

Vaccination Vaccine Immune Response Manufacturing 130

Pharmaceutical Technology

JUNE 10, 2023

The vaccine works by inducing the body's immune response. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.

Production 100

Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

The vaccine works by inducing the body's immune response. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.

Production 100

Production Vaccination Vaccine Immune Response 100

pharmaphorum

DECEMBER 4, 2020

Under the agreement Valneva could receive up to $308 million in cash payments, after Pfizer paid $130 million up front for marketing rights to the vaccine if it succeeds in the clinic. VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

Vaccination 119

Vaccination Vaccine Bacterium Protein 119

pharmaphorum

FEBRUARY 22, 2021

In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. At the time analysts said that this was likely due to an insufficient concentration of the antigen and the companies have refined their antigen formulation hoping for a better immune response including in older adults.

Vaccination 89

Vaccination Vaccine Recombinant DNA Technology Trials 89

XTalks

JULY 28, 2021

The companies are set to go head-to-head in a high-stakes market battle involving billions of dollars — a battle Pfizer has been winning for over a decade now. This could significantly help Merck in the race to get a next-gen pneumonia vaccine to kids as children make up about 80 percent of the market for pneumococcal vaccines.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

World of DTC Marketing

AUGUST 3, 2020

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. An editorial in today’s Times said it pretty clearly “I’m a vaccine researcher, and even I would place myself in the “not sure” bucket.

Vaccination 155

Vaccination Vaccine Immune Response Trials 155

Pharmaceutical Technology

AUGUST 12, 2022

The concept behind this form of treatment is that the introduction of these cells will enhance the immune response to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives. Overall, the global CAR-T cell market for all indications was worth $1.7

Development 130

Development Drugs Immune Response Marketing 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.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

APRIL 15, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

pharmaphorum

NOVEMBER 24, 2020

Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

Vaccination 111

Vaccination Vaccine Immune Response Marketing 111

pharmaphorum

DECEMBER 17, 2020

Siltuximab is an IL-6 inhibiting drug that was originally developed and marketed by the Johnson & Johnson’s Janssen unit for the rare disorder idiopathic multicentric Castleman’s disease. Primary outcome of the SILVAR study will be all-cause 28-day mortality. EUSA Pharma bought global rights to the drug from Janssen in $115 million.

Drugs 105

Drugs Immune Response Trials Clinical Trials 105

pharmaphorum

AUGUST 25, 2021

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise.

Vaccination 105

Vaccination Vaccine Immune Response Marketing 105

pharmaphorum

JULY 20, 2022

Shares in VBL Therapeutics have lost around 78% of their value in pre-market trading after the company reported a phase 3 trial of its lead gene therapy VB-111 for ovarian cancer failed a pivotal trial. ” The company’s fall into penny share ($0.44) territory from its year-long high of more than $2.50

Gene Therapy 98

Gene Therapy Gene Immune Response Antibody 98

Roots Analysis

DECEMBER 22, 2021

The Regulatory T-Cell Therapies (Tregs) are a mature subpopulation of T-cells that play a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. Regulatory T-Cell Therapies (Tregs) Market by Target Indications. Web: [link].

Immune Response 52

Immune Response Research In-Vivo Marketing 52

pharmaphorum

OCTOBER 2, 2020

Vaccibody, which is also entitled to tiered royalties on sales of any marketed products, will develop the DNA-based individualised neoantigen vaccines until the end of phase 1b. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

Vaccination 59

Vaccination Vaccine Immune Response Drugs 59

pharmaphorum

JUNE 28, 2022

Shares in Sutro rocketed in pre-market trading in the wake of the announcement, rising more than 50% before slipping back slightly to a 30% increase at the time of writing. Astellas and Sutro haven’t however disclosed the disease targets covered by their partnership.

Antibody 105

Antibody Immune Response Gene Therapy Drugs 105

pharmaphorum

DECEMBER 6, 2022

In March, once the worst of the crisis was passed and COVID-19 vaccines entered regular commercial trade with producers competing for the booster shot market, Moderna said it was time to update its pledge and start to enforce its IP rights.

Vaccination 97

Vaccination Vaccine Immune Response Sales 97

XTalks

APRIL 7, 2021

The new, revised EUA will allow the company to market the test for the qualitative detection of SARS-CoV-2 from nasal swab samples for screening use with serial testing. The test is intended for the detection of COVID-19 infection, either a recent or previous infection, as detected through an adaptive antibody immune response to SARS-CoV-2.

Antibody 102

Antibody Immune Response Radiology Marketing 102

pharmaphorum

NOVEMBER 14, 2022

Sanofi and Regeneron have predicted that Dupixent could make around $13 billion a year at peak, which would propel the drug into the top five biggest pharmaceutical sellers.

Sales 118

Sales Immune Response Drugs Medicine 118

XTalks

JULY 31, 2024

Related: Pfizer’s Newly Approved Litfulo to Take on Eli Lilly’s Olumiant in Growing Alopecia Market So, what is alopecia areata? Alopecia areata occurs when the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face and sometimes other body parts.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 22, 2022

Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US. As part of the deal, Sanofi will pay $35 million to Provention along with another $20 million to secure the right to first negotiation on exclusive global marketing rights when Tzield is approved in other countries.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

Delveinsight

SEPTEMBER 8, 2021

As per DelveInsight’s report on Benlysta (Belimumab) market forecast , the sale of Belimumab has kept on increasing year after year. Currently, the SLE therapeutics market is revolving around only one drug i.e It is the top-selling medication in the market. Anifrolumab (MEDI-546).

Marketing 52

Marketing Sales FDA Approval Antibody 52

Pharmaceutical Technology

AUGUST 24, 2022

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1%

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130