The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.?Novavax?is Source link.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. Roughly 16.4 million U.S.

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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. The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Related Information.

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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

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.

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Drug Target Review

MAY 14, 2024

The combination of P1 with antiPD1 more efficiently activated innate and adaptive immune responses than either P1 or antiPD1 alone by re-energising T cell effector functions, thus providing the remarkable reduction of tumour growth in solid tumours and extended survival period.

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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

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

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

8 Translation inhibitors Developing translation inhibitors will always be challenging due to their critical effects on healthy tissues, but omacetaxine was approved by the US Food and Drug Administration (FDA) in 2012 for the treatment of adult patients with chronic myeloid leukaemia.

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The Pharma Data

AUGUST 19, 2021

FDA, CDC and other health authorities and will share new data shortly regarding boosting with the Johnson & Johnson COVID-19 vaccine. We are engaging with the U.S. Ensuring long-term and durable protection against hospitalization and death are critical in curbing the COVID-19 pandemic.

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The Pharma Data

JANUARY 25, 2021

The 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,” the researchers said. The FDA granted Regeneron’s antibody cocktail Emergency Use Authorization in November.

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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

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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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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Codon

NOVEMBER 3, 2024

If present before vaccination, memory immune cells primed to destroy the environmental relatives might cross-react with and neutralize the BCG strain before it has a chance to set up an immune response against itself and M. Food and Drug Administration (FDA)-approved drug library, some of which inhibit E. tuberculosis.

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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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Drug Target Review

OCTOBER 26, 2023

Alipogene tiparvovec and voretigene neparvovec-rzyl, two recombinant AAV-based gene therapy products, were approved by the European Medicines Agency (EMA) to treat lipoprotein lipase deficiency in 2012 2 and by the US Food and Drug Administration (FDA) to treat inherited retinal dystrophy in 2017, respectively.

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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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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

OCTOBER 21, 2020

Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??) The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? T cell therapy in NHL patients. Forward-Looking Statements.

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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 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. 24, 2020 ). Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.”.

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PerkinElmer

NOVEMBER 9, 2022

These cells overexpress PD-L1, leading to inhibition of cytotoxic T-cells by binding to the PD-1 receptor on activated T-cells, and subsequent evasion of an immune response. To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs).

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. This is a question that sponsors have been struggling with for quite some time.

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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

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.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. SAN CARLOS, Calif. ,

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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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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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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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New Drug Approvals

DECEMBER 16, 2023

3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immune responses against pathogens. Food and Drug Administration (FDA). 1] It is taken by mouth. [1] 5 December 2023.

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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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DrugBank

MAY 6, 2024

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. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

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Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.

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The Pharma Data

NOVEMBER 24, 2020

The FDA, which has not yet commented on the situation, could ask the company to collect more data due to the mistake, which could delay receiving Emergency Use Authorization (EUA). There are a number of variables that we need to understand and what has been the role of each one of them in achieving the difference in efficacy.”.

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The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (FDA). The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 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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