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. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Vaccination Vaccine Trials Immune Response 98

pharmaphorum

DECEMBER 22, 2020

Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot was independently backed by the UK’s regulator. But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants.”.

Vaccination 81

Vaccination Vaccine Protein Immune Response 81

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 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. However, the similarity between the two proteins is not great enough for anti-spike antibodies to cross-react with placental syncytin-1.

Vaccination 105

Vaccination Vaccine Protein Immune Response 105

pharmaphorum

OCTOBER 17, 2022

When James P Allison and Tasuku Honjo were awarded the Nobel Prize for Medicine in 2018 for their discovery of cancer therapy through inhibition of negative immune regulation, it shone a light on decades of research into recruiting the immune system to fight cancer.

Immune Response 115

Immune Response Development Research Protein 115

pharmaphorum

FEBRUARY 24, 2021

Changes in the “Spike” protein targeted by nearly all the vaccines approved or in development could also lead to more infectious variants, such as the strain that emerged in Kent and is now prevalent across most of the UK. Manufacturers are also encouraged to study the response in previously vaccinated and unvaccinated people.

Vaccination 59

Vaccination Vaccine Immune Response Regulation 59

The Pharma Data

SEPTEMBER 14, 2020

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness. Source link.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

pharmaphorum

AUGUST 24, 2020

Just last week, BMS paid $475 million upfront to license Dragonfly Therapeutics’ DF6002, a long-lasting fusion protein that looks like the “tail” (Fc) end of an IL-12 antibody. The rationale behind the drug is that it causes the area around a tumour to become inflammatory, stimulating an immune response against the cancer.

Immune Response 59

Immune Response Antibody Drugs Development 59

pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

Vaccination 59

Vaccination Vaccine RNA Immune Response 59

The Pharma Data

NOVEMBER 17, 2020

Located in Oss, the Netherlands, Lead Pharma is a clinical-stage biopharmaceutical company focused on the development of novel small-molecule therapies for patients suffering from autoimmune diseases (a subset of immune-mediated diseases) and cancer. . The agreement encompasses Lead Pharma’s entire pipeline.

Immune Response 52

Immune Response Licensing Licensing Sales 52

pharmaphorum

SEPTEMBER 12, 2022

” The new 30 µg booster shot is bivalent – with mRNA coding for spike protein from both the original wild-type SARS-CoV-2 virus as well as the BA.4/BA.5 4-5 is expected to be more effective than Comirnaty at triggering an immune response against the BA.4 5 towards the end of August. 5 subvariants.”

Vaccination 52

Vaccination Vaccine Immune Response Protein 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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 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. Dietary changes, including restriction of salt and animal protein, are also recommended.

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. About the Progranulin-Elevating Monoclonal Antibodies – AL001 and AL101.

Genetics 52

Genetics Gene Antibody Development 52

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. Transfer RNA (tRNA): Transfer RNA is an indispensable adaptor molecule central to the translation of mRNA to proteins. Key player engaged in the development of endless RNA based therapeutics is Laronde.

RNA 40

RNA Vaccination Vaccine Development 40

The Pharma Data

DECEMBER 15, 2020

Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. The protein may be involved in such conditions, and a CRP test may be used to find or monitor conditions that cause inflammation. The human monoclonal antibody targets specific immune plasma cells.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

OCTOBER 21, 2020

Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released.

Gene Therapy 40

Gene Therapy Immune Response Sales Gene 40

Delveinsight

SEPTEMBER 8, 2021

Baricitinib, also known as LY3009104 or INCB028050 , is a novel orally bioavailable inhibitor of the tyrosine-protein kinase JAK1 or JAK2. According to the findings of the study, 67 percent of patients in the 4-mg group achieved the SLE Disease Activity Index-2K response, compared to 53 percent in the placebo group.

Marketing 52

Marketing Sales FDA Approval Antibody 52

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. About TNX-1800.

Vaccination 40

Vaccination Vaccine Development Medicine 40

pharmaphorum

APRIL 28, 2021

“Text mining was also able to highlight new insights into the mechanisms of pancreatic cancer’s immune evasion, which refers to cancer cells’ ability to evade an immune response” . Figure 1: Trending ‘Protein and Genomic’ terms with a semantic relationship to pancreatic cancer.

Immune Response 105

Immune Response Life Science Genome Genomics 105

XTalks

DECEMBER 12, 2024

The test builds upon the MeMed BV test, which received FDA clearance in July 2023 and a CE marking under the European In Vitro Diagnostic Devices Regulation (IVDR) in the European Union (EU). Its the first FDA-cleared host-immune response assay for accurately distinguishing between bacterial and viral infections in just 15 minutes.

In-Vitro 92

In-Vitro Immune Response Protein Sales 92

XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. At six months, 29.5 Changing the Face of Malaria.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

The Pharma Data

JANUARY 21, 2021

Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. market specifically target the spike protein to prevent transmission, explained Dr. Kathryn Edwards, scientific director of the Vanderbilt University Vaccine Research Program in Nashville.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

pharmaphorum

FEBRUARY 28, 2021

Prior to that, the agency’s reviewer said the regulator was satisfied with data showing the shot was 66% effective at preventing COVID-19 28 days after a single dose. The vaccine causes the body to create its own copies of the protein, stimulating an immune response.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

Pharmaceutical Technology

APRIL 11, 2023

The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response. It carries out operations in the regulated markets of the US and Europe, as well as in Latin America and South Africa.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

pharmaphorum

SEPTEMBER 8, 2021

Kadmon claimed approval for Rezurock (belumosudil) in July as a treatment for chronic graft versus host disease (GVHD) – a common and often fatal complication that can follow a bone marrow transplant and which occurs when the donated cells mount an immune response against the transplant recipient’s tissues and organs.

Drugs 52

Drugs Sales Immune Response Marketing 52

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

MARCH 13, 2022

People who gained immunity – either through vaccination or exposure – against the original strain of SARS-CoV-2, the virus that causes COVID-19, also are likely to have some protection against the pathogen’s omicron variant. The samples were stored after the researchers measured the T cell response. population.

Immune Response 52

Immune Response Protein Medicine Genetics 52

The Pharma Data

DECEMBER 18, 2020

The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Director of the FDA’s Center for Biologics Evaluation and Research. View original content to download multimedia: [link]. SOURCE U.S. Food and Drug Administration.

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

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.

Development 40

Development Vaccination Vaccine Production 40

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

Vaccination 130

Vaccination Vaccine Regulation Immune Response 130

The Pharma Data

AUGUST 3, 2021

whose proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. The company announced the acquisition of Protomer Technologies Inc., Loxo Oncology at Lilly and Kumquat Biosciences Inc.

Antibody 52

Antibody Sales Development Production 52

pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. .

Vaccination 98

Vaccination Vaccine Antibody Immune Response 98

pharmaphorum

JUNE 14, 2021

Shareholders may also have the jitters because another late-stage COVID-19 vaccine developer – Ocugen – was told by the FDA it would have to file for full approval rather than going down the speedier EUA route, becoming the first drugmaker to be affected by the regulator’s stricter stance on emergency approvals.

Vaccination 84

Vaccination Vaccine Immune Response Protein 84

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 1 sub-lineage on 19 July.

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Manufacturing Vaccination Vaccine Packaging 130