XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. Finally, addressing the time-consuming and costly transition from non-clinical to clinical development due to difficulties in predicting human immune responses is another issue.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

The Pharma Data

AUGUST 28, 2020

Oxford coronavirus vaccine triggers immune response. The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020. UK signs deals for 90 million virus vaccine doses.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

pharmaphorum

DECEMBER 1, 2021

BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy.

Drugs 52

Drugs Immune Response Trials Clinical Trials 52

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

XTalks

JUNE 21, 2024

This transition led to roles in companies such as Shire, which spun out a division to start a new company called Supernus Pharmaceuticals, in which he engaged in corporate development, licensing and strategic management, taking companies public and navigating mergers and acquisitions.

Development 52

Development Immune Response Drugs Regulation 52

XTalks

APRIL 2, 2021

We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”. 1.351 variant, which may have the potential to evade the immune response.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

The Pharma Data

DECEMBER 15, 2020

The human monoclonal antibody targets specific immune plasma cells. The researchers regulated the abnormal immunological memory processes found in these patients. Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most.

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. relevant government policies and regulations relating to our industry.

In-Vivo 40

In-Vivo Development Immune Response Big Data 40

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.

Vaccination 40

Vaccination Vaccine Development Medicine 40

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

DECEMBER 21, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

Trials 40

Trials Production Sales Manufacturing 40

XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. Malaria Vaccine Phase II Trial. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

FEBRUARY 9, 2021

InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells. Regulus meanwhile remains a microRNA player, but has suffered a number of setbacks.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

The Pharma Data

FEBRUARY 22, 2021

Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40

The Pharma Data

OCTOBER 18, 2020

” EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.

Immune Response 40

Immune Response Antibody Regulation Development 40

The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

Antibody 52

Antibody Sales Development Production 52

pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

Vaccination 64

Vaccination Vaccine Immune Response Gene Sequencing 64

XTalks

SEPTEMBER 16, 2021

The federal health regulator maintains that boosters of Pfizer’s vaccine may not be needed, but in documents prepared for outside advisors, FDA scientists acknowledged yesterday that a third dose can heighten immune responses.

Vaccination 52

Vaccination Vaccine Immune Response Clinical Trials 52

pharmaphorum

JUNE 2, 2021

The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

The Pharma Data

SEPTEMBER 8, 2020

Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NanoFlu , its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NanoFlu , its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52