NIH Director's Blog: Drug Development

JUNE 30, 2020

It’s now clear that nearly everyone who recovers from coronavirus disease 2019 (COVID-19) produces antibodies that specifically target SARS-CoV-2, the novel coronavirus that causes the infection. But there is a catch: 99 percent of the study’s participants didn’t make enough neutralizing antibodies to mount an ideal immune response.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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The Pharma Data

DECEMBER 16, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 GAITHERSBURG, Md., 16, 2020 (GLOBE NEWSWIRE) — Novavax , Inc. About Novavax. Novavax, Inc.?(Nasdaq:

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Drug Discovery World

MAY 6, 2024

Amsterdam: The centre of European life sciences As a result of the UK withdrawing from the EU, in 2019 the EMA headquarters was moved from London to Amsterdam. The company is now investigating a promising gene therapy for Huntingdon’s disease in a Phase I/II trial, with patients already showing signs of preserved neurological function.

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The Pharma Data

NOVEMBER 10, 2020

P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. Crohn’s Disease Therapeutics Market Size $4.7 Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”.

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The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older.

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. 9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications. Nature reviews Drug discovery 18 , 358-378 (2019).

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The Pharma Data

NOVEMBER 19, 2020

Centers for Disease Control and Prevention (CDC), there were more than 216,000 confirmed COVID-19 cases in healthcare workers in the U.S., The results were published in the journal BMC Infectious Diseases. “We Deep Sleep May Protect Against Alzheimer’s Disease. As of November 15, 2020, according to the U.S. Working with C.

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The Pharma Data

JANUARY 11, 2021

Centers for Disease Control and Prevention (CDC) cautioned that the COVID-19 vaccine seems to cause severe allergic reactions at a much higher rate than other vaccines, such as the flu vaccine. . Centers for Disease Control and Prevention (CDC) to provide genomic sequencing of SARS-CoV-2 samples. A study published by the U.S.

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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.

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The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. today announced that they have submitted Phase 1 data to the U.S. today announced that they have submitted Phase 1 data to the U.S.

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The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. GSK’s response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development. GSK commitment to tackling COVID-19.

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The Pharma Data

MARCH 9, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Canakinumab is a first-in-class interleukin-1beta (IL-1?) million new cases each year 11 , 1 3.?Currently,

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The Pharma Data

NOVEMBER 9, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. GAITHERSBURG, Md.,

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The Pharma Data

JULY 23, 2021

Vaccines have been and will remain critical to protecting lives against this devastating disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As a long-term partner to the U.S. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Canakinumab is a first-in-class interleukin-1beta (IL-1?) million new cases each year 11 , 1 3.?Currently,

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The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. . PLYMOUTH MEETING, Pa. ,

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019. Available online.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

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The Pharma Data

JANUARY 6, 2021

The alliance, announced on October 14, 2019 , has assisted in advancing the 89Zr CD8 Immuno-PET technology. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases.

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The Pharma Data

JULY 6, 2021

“Breaking barriers for people living with rare blood disorders requires that we push ourselves to transform the therapeutic landscape, ” said Karin Knobe, MD, PhD, Head of Development, Rare Disease s and Rare Blood Disorders at Sanofi. “We Three additional Phase 2 studies in immunological diseases are planned to start in 2021.

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The Pharma Data

JUNE 24, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.: The Pfizer?BioNTech

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The Pharma Data

OCTOBER 26, 2020

The National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor, could not verify the safety issue, but their analysis also indicated there was little likelihood the antibody would help the hospitalized patients. The approval marks the first drug approved by the U.S. Organizational Actions/Announcements .

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The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

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The Pharma Data

MARCH 25, 2021

With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. 4,5 Efficacy varied by serotype.

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The Pharma Data

SEPTEMBER 17, 2020

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. In 2019, Roche invested CHF 11.7

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The Pharma Data

NOVEMBER 1, 2020

Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug. Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. NEW YORK and LONDON, Nov.

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The Pharma Data

JANUARY 24, 2021

In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. Kenilworth, N.J.,

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The Pharma Data

JANUARY 20, 2021

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Forward-Looking Statements.

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

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The Pharma Data

MAY 12, 2021

New data and analyses to be presented from the pivotal Phase 3 CADENZA and CARDINAL studies of sutimlimab, a first-in-class investigational C1s inhibitor that has the potential to be the first approved treatment for hemolysis in adults with cold agglutinin disease (CAD), a serious and chronic autoimmune hemolytic anemia. Oral Presentation.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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The Pharma Data

SEPTEMBER 8, 2020

(LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Cambridge, UK.

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The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., 35 — Have chronic kidney disease — Have diabetes — Have immunosuppressive disease — Are currently receiving immunosuppressive treatment — Are ?65

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. The vaccine was 94.1%

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Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease. The findings were published in the journal The Lancet Microbe.

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