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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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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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

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

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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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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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S.

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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

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

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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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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

NOVEMBER 30, 2020

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). 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

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The Pharma Data

JANUARY 21, 2021

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. The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). The company also has an extensive preclinical pipeline.

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The Pharma Data

NOVEMBER 18, 2020

The FDA is expected to assemble its vaccines advisory committee Dec. Former FDA Commissioner Scott Gottlieb hailed Pfizer/BioNTech’s success as a “game change” and predicted their vaccine could be the solution to the health crisis. 8-10 to discuss the recent developments, including Pfizer/BioNTech’s and Moderna’s candidates.

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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

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. Food and Drug Administration (FDA) earlier this year as an expansion to the existing EUA for the primary series.

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The Pharma Data

SEPTEMBER 8, 2021

BTK is an intracellular signaling molecule involved in innate and adaptive immune responses involved in certain immune-mediated diseases. Rilzabrutinib was granted FDA Fast Track Designation for ITP in November 2020 and for pemphigus vulgaris in May 2021.

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The Premier Consulting Blog

APRIL 18, 2024

This is due to the high-risk nature of these kinds of products (especially for a first-in-class therapy) and the fact that some cell or gene therapies can only be administered once due to the development of immune responses to the drug product.

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The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today. The Pfizer – BioNTech COVID-19 vaccine was sent to the FDA for possible Emergency Use Authorization (EUA) on Friday, November 20. Also, the U.S.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. CHENGDU, China , Feb.

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The Pharma Data

JULY 23, 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. .:

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The Pharma Data

JANUARY 19, 2021

On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The company is working on a new approach to immunotherapy that uses the body’s own T-cells to create specific, potent, and durable immune responses for cancer and other life-threatening immune-mediated disease.

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The Pharma Data

DECEMBER 15, 2020

In late October, SetPoint Medical received Breakthrough Device Designation from the FDA for the use of its novel bioelectronic device by patients with rheumatoid arthritis (RA) who have incomplete response to, or are intolerant to multiple biologic drugs. The FDA has set an action date of July 7, 2021. Bioelectronic Platform.

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The Pharma Data

OCTOBER 6, 2021

The study assesses the safety profile and immune response when COVID-19 mRNA investigational booster vaccine (100 mcg dose) and high-dose quadrivalent influenza vaccine are administered simultaneously. Full results of the study will be published later this year. About Fluzone ® High-Dose Quadrivalent / Efluelda ®.

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The Pharma Data

SEPTEMBER 30, 2021

An expert review by a world group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe COVID is so high that booster doses for the overall population aren’t appropriate at this stage within the pandemic. Considerations in boosting COVID-19 vaccine immune responses.

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The Pharma Data

FEBRUARY 23, 2022

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. Figure 1a – Pre- vs post-booster neutralizing antibody titers in 18-55-yr old participants.

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The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S.

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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. .: BioNTech COVID-19 Vaccine.

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

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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. Food and Drug Administration (FDA).

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The Pharma Data

JANUARY 15, 2021

The FDA’s approval of the Pfizer-BioNTech vaccine, for example, listed pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever as common reactions.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. Friday, December 11, 2020. immediately.

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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.

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NIH Director's Blog: Drug Development

OCTOBER 27, 2020

While further study is needed to understand all the details and their implications, it suggests that this interaction may alter important aspects of the human immune response, including blocking interferon signals that are crucial for sounding the alarm to prevent serious illness.

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The Pharma Data

JULY 6, 2021

Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. There are currently no FDA-approved treatment options for FTD. About the Progranulin-Elevating Monoclonal Antibodies – AL001 and AL101.

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