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. The post The role of T-cells in future SLE therapies appeared first on Pharmaceutical Technology.

Immune Response 147

Immune Response Marketing Antibody Trials 147

Pharmaceutical Technology

AUGUST 24, 2022

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% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. CAGR between 2020 and 2028.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

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

XTalks

DECEMBER 20, 2024

Steqeyma was evaluated through a comprehensive set of studies, including a Phase III trial that showed that the biosimilar met the primary endpoint of improved Psoriasis Area and Severity Index (PASI) scores by Week 12 and sustained results through Week 28. billion by 2034, driven by an 11.2 percent compound annual growth rate (CAGR).

FDA Approval 52

FDA Approval Immune Response Antibody Marketing 52

pharmaphorum

FEBRUARY 22, 2021

In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. The vaccine is based around an adjuvanted recombinant protein, which will be tested in a new phase 2 study to assess the response including in older adults.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

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

Vaccine 147

Vaccine Vaccination Immune Response Protein 147

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.

Vaccine 130

Vaccine Vaccination Protein Immune Response 130

Pharmaceutical Technology

MAY 10, 2023

XinThera’s therapy targeting MK2 is expected to enter clinical trials later in 2023. The acquisition will give Gilead Sciences access to XinThera’s portfolio of two small molecule inhibitor programmes, one of which targets PARP1 to treat cancer and the other of which targets MK2 for inflammatory diseases.

Immune Response 130

Immune Response DNA Clinical Trials Clinical Trials 130

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

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.

Vaccine 155

Vaccine Vaccination Immune Response Trials 155

Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The vaccine works by inducing the body's immune response. Influenza vaccine 2 overview Vaccine is under development for the prevention of infections caused by pandemic influenza virus.

Production 100

Production Vaccine Vaccination Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The vaccine works by inducing the body's immune response. Influenza vaccine 2 overview Vaccine is under development for the prevention of infections caused by pandemic influenza virus.

Production 100

Production Vaccine Vaccination Immune Response 100

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. 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

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. The vaccine is currently being tested in children in Phase III trials and the company is hoping to get FDA approval by the end of the year.

FDA Approval 89

FDA Approval Vaccine Vaccination Immune Response 89

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

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

Trials 98

Trials Gene Hormones Clinical Trials 98

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies. Product Type-Specific Analysis.

Development 161

Development Production Immune Response Licensing 161

XTalks

NOVEMBER 10, 2020

Update (November 10, 2020): Pfizer and BioNTech announced in a press release yesterday that their candidate COVID-19 vaccine was found to be more than 90 percent effective in preventing infection by the novel coronavirus in Phase III trials. The ongoing Phase III trial continues to evaluate the mRNA vaccine in close to 44,000 individuals.

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Vaccine Vaccination Trials Clinical Trials 75

pharmaphorum

NOVEMBER 24, 2020

AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

Vaccine 111

Vaccine Vaccination Immune Response Marketing 111

XTalks

NOVEMBER 10, 2020

Update (November 11, 2020): Quebec-based biopharmaceutical company Medicago has announced positive results from a Phase I trial of its candidate plant-derived vaccine. Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate.

Vaccine 52

Vaccine Vaccination Trials Immune Response 52

pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The question now is whether Ampio has the resources on hand to run a new study without raising additional funding.

Immune Response 111

Immune Response Trials Clinical Trials Clinical Trials 111

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

Immune Response 52

Immune Response Vaccine Vaccination Clinical Trials 52

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

XTalks

NOVEMBER 22, 2022

In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo. Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US. Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

pharmaphorum

SEPTEMBER 15, 2020

The antibody – called lenzilumab – targets colony stimulating factor 2 (CSF2) and granulocyte-macrophage colony stimulating factor (GM-CSF), two cytokines that are linked to the runaway immune response that can result in serious lung damage in COVID-19. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccine 111

Vaccine Vaccination Immune Response Trials 111

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.

Vaccine 105

Vaccine Vaccination Immune Response Marketing 105

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

pharmaphorum

NOVEMBER 14, 2022

Sanofi and Regeneron are running a phase 3 trial of the drug in COPD patients with type 2 inflammation called NOTUS that is due to generate results next year.

Sales 118

Sales Immune Response Drugs Medicine 118

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351)

Vaccine 98

Vaccine Vaccination Protein Immune Response 98

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.

Vaccine 59

Vaccine Vaccination Immune Response Drugs 59

pharmaphorum

JANUARY 17, 2023

Shares in the company fell sharply this morning after the announcement of the deal, which will see the two companies combine behind lead programme ELI-002, an immunotherapy targeting KRAS-driven cancers that is currently in a phase 1 trial in pancreatic ductal adenocarcinoma and colorectal cancer. Darrell Irvine.

Immune Response 93

Immune Response Trials Engineer Sales 93

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

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.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

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

Delveinsight

DECEMBER 22, 2020

Vorasidenib is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, AG-270 is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while AG-636 is a novel inhibitor of dihydroorotate dehydrogenase.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52