The Pharma Data

SEPTEMBER 30, 2021

Our results show that the candidate vaccine formulation is safe, produces rapid immune responses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “We

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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. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. However, if the immune system malfunctions, it can attack healthy cells, tissues and organs. Autoimmune disease impacts different parts of the body, weakening functionality. Autoimmune diseases affect more than 24 million people in the U.S.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. Following today’s FDA approval, the U.S.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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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. Pfizer Inc.

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Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. 15 ISACs use small immuno-agonist molecules conjugated to the antibody to boost the immune response while minimising toxicity.

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The Pharma Data

MARCH 29, 2022

The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. ” The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. SILVER SPRING, Md. , Hahn , M.D.

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The Pharma Data

JANUARY 5, 2021

However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence,” they added. You’re just hoping that you’re right,” said Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

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Codon

JULY 14, 2024

In contrast, people with sickle cell disease commonly receive red blood cell transfusions to alleviate vaso-occlusive pain crises. 2 And while transfusions are among the safest procedures in medicine, there is still a very slight risk of transmission of infectious diseases and adverse immune reactions. In the U.S.,

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DrugBank

MAY 6, 2024

This category encompasses a broad spectrum of treatments including vaccines, blood components, gene therapies, and more, each tailored to combat diseases in highly specific ways. A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. If the vaccine receives the designation, the FDA will allow some people to receive the product as the agency continues to look at the data. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA.

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The Pharma Data

JANUARY 22, 2021

The EUA covers adults and children over age 12 who have mild or moderate COVID-19 and are at high risk for severe disease. The Weinreich article also reports that the “antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline.

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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.

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Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection. About Trimer-Tag © Technology.

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The Pharma Data

JULY 8, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

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Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. Over the decade, entire categories of diseases disappeared. 2024 Statistical models of organisms have existed for decades.

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New Drug Approvals

DECEMBER 16, 2023

2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. of patients experienced a sustained hemoglobin improvement without transfusions respectively.

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The Pharma Data

JANUARY 17, 2021

Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing its single-dose COVID-19 vaccine candidate created an immune response that lasted at least 71 days. The data showed that the vaccine induced an immune response and was generally well-tolerated.

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Drug Target Review

DECEMBER 13, 2024

These types differ in their etiology, natural history, and present distinct challenges in disease management. 7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. percent of total cancer fatalities.

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The Pharma Data

OCTOBER 21, 2020

Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??) MENLO PARK, Calif.

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PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998.

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The Pharma Data

JANUARY 11, 2021

Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests. . 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. .

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The Pharma Data

JANUARY 5, 2021

.” The clinical trial involved 24 COVID patients at one of two Miami-area hospitals who had developed severe acute respiratory distress syndrome, a condition in which the body’s immune response to a serious infection causes the lungs to fill with fluid.

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The Pharma Data

SEPTEMBER 8, 2021

While these results are disappointing, w e believe th e rilzabrutinib clinical program holds great potential to address the unmet treatment needs of people living with immune-mediated diseases , ” said Naimish Patel, Head of Global Development, Immunology and Inflammation. “

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The Pharma Data

JULY 6, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

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The Pharma Data

JANUARY 21, 2021

Its core therapeutic areas are immuno-oncology, autoimmune disorders, and infectious diseases. Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. Precigen is focused on next-generation gene and cell therapy using precision technology.

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Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. CD24 and Siglec-10 Selectively Repress Tissue Damage-Induced Immune Responses.

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The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

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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. Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA).

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The Pharma Data

MARCH 3, 2022

The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.

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