Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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Development Production Immune Response Licensing 161

The Pharma Data

MARCH 25, 2021

today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. Source link:[link].

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

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. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

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Protein Vaccination Vaccine Immune Response 126

pharmaphorum

FEBRUARY 18, 2021

Mutations may alter neutralisation by affecting spike function rather than antigen response and its also unclear from this study how the T-cell response is affected. The body’s immune response to the coronavirus is not limited to antibodies with CD8+ T-cells also playing roll combating infections.

Immune Response 52

Immune Response Genetic Engineering Vaccination Vaccine 52

pharmaphorum

DECEMBER 11, 2020

Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults. While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.

Immune Response 73

Immune Response Trials Vaccination Vaccine 73

pharmaphorum

MARCH 28, 2022

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. 2, and would be sharing these data with regulators around the world. 2 subvariant of Omicron. Previously, when the original BA.1

Antibody 52

Antibody Immune Response Regulation Sales 52

pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). Two years after signing a $3.9 Analysts at Jefferies have previously said they think epcoritamab could become a $1.5

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Licensing Licensing Immune Response Antibody 64

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

pharmaphorum

AUGUST 16, 2021

The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and will follow that with filings in Europe and elsewhere in the world in the coming weeks.

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FDA Approval Vaccination Vaccine Antibody 105

The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter. 14, 2020 ). 2 infection.

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Vaccination Vaccine Immune Response RNA 40

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

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.

Immune Response 64

Immune Response Vaccination Vaccine Gene Sequencing 64

pharmaphorum

AUGUST 24, 2020

Forbius has also been working on some other targets, including an EGFR-targeting antibody-drug conjugate (ADC), but these will be spun into another company that will remain in the hands of its current shareholders.

Immune Response 59

Immune Response Antibody Drugs Licensing 59

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

Immune Response 72

Immune Response Trials Drugs Containment 72

Find Me Cure

APRIL 23, 2020

This means that in order for herd immunity to work, 50-70% of the world population needs to get infected and then develop antibodies. . But another huge question mark here is if it’s even possible for people to become immune for long enough for this theory to even work. Thus, herd immunity wouldn’t work in this scenario.

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Immune Response Antibody Scientist Development 117

pharmaphorum

AUGUST 31, 2021

The move follows phase 1/2 results with SK bio’s GBP510, which found that it stimulated neutralising antibodies against SARS-CoV-2 in all 80 recipients, with no safety issues recorded. Neutralising antibody titres in the blood were five to eight times higher than people who recovered from COVID-19.

Vaccination 59

Vaccination Vaccine Protein Immune Response 59

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.

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Immune Response Development Research Protein 115

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

pharmaphorum

SEPTEMBER 29, 2020

The US drugs regulator has placed the phase 2/3 trial of INO-4800 on partial clinical hold while it seeks answers from the company about the DNA-based vaccine as well as the device used to deliver the shot to patients in the study.

Vaccination 52

Vaccination Vaccine Trials DNA 52

pharmaphorum

APRIL 27, 2021

Participants showed high titres of malaria-specific anti-NANP antibodies 28 days after the third vaccination, which were almost doubled with the higher adjuvant dose. The Serum Institute of India has manufactured the malaria vaccine and says it could deliver more than 200 million doses as soon as it is approved by regulators.

Vaccination 52

Vaccination Vaccine Immune Response Trials 52

pharmaphorum

SEPTEMBER 7, 2022

The Swiss pharma group has agreed to buy Seattle-based biotech Good Therapeutics and its preclinical-stage PD-1-regulated IL-2 receptor agonist programme for $250 million upfront, with undisclosed milestone payments on offer tied to development, regulatory, and commercial objectives.

Immune Response 52

Immune Response Engineer Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 27, 2021

The companies said in December they were having to rethink the antigen formulation of their vaccine after it failed to produce the desired immune response in people aged 50 years and older, although results were more favourable in younger age groups. This is expected to delay availability of the vaccine until later this year.

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Vaccination Vaccine Immune Response Manufacturing 69

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. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

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Vaccination Vaccine RNA Immune Response 59

The Pharma Data

NOVEMBER 17, 2020

t for the treatment of autoimmune diseases , which occur when the body’s immune system attacks its own cells and tissues as foreign invaders. . While the antibody responsible for immune-mediated diseases is yet to be identified, they are thought to be regulated by an aberrant immune response.

Immune Response 52

Immune Response Licensing Licensing Sales 52

pharmaphorum

JANUARY 7, 2021

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

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.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

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

APRIL 6, 2021

According to Channel 4 news, two senior sources have said the regulator is being urged to offer other vaccines to younger people because of a possible link between the AZ jab and blood clots, in particular a rare condition known as cerebral venous sinus thrombosis (CVST).

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Vaccination Vaccine Immune Response Manufacturing 80

Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

Marketing 65

Marketing Drugs Antibody Compliance 65

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. Eligible U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

OCTOBER 21, 2022

New research has identified immune targets for chemotherapy-resistant breast cancers. The research sheds light on the function of immune cells in these patients and will help future studies to enhance the anti-cancer immune response in breast cancer.

In-Vivo 52

In-Vivo Research Drugs Engineer 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

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. 1.351 variant, which may have the potential to evade the immune response.

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Vaccination Vaccine Trials Clinical Trials 59

The Pharma Data

MARCH 8, 2021

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1?) Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses 9,10. 6 , 7 and neutralizes IL-1? By neutralizing IL-1?,

Trials 52

Trials Immune Response Clinical Trials Clinical Trials 52