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 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

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. Small Molecule Inhibitors. Oral, Small Molecules.

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Advarra

JANUARY 11, 2024

After injection of such a vaccine, the mRNA instructs cells to produce proteins designed to stimulate an immune response against these same protein targets when they show up in viruses or in tumor cells. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

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Drug Target Review

DECEMBER 13, 2024

A notable development in this area is the recent approval by the US Food and Drug Administration (FDA) for a BiTE targeting DLL3, aimed at treating adults with extensive-stage SCLC who have experienced disease progression on or after platinum-based chemotherapy.

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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. Its lead candidate is CLN-081, an oral small molecule designed to be a next-generation, irreversible EGFR inhibitor. Ortho Clinical Diagnostics is a leader in in vitro diagnostics. Most Read Today.

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The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. Auxora is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation.

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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. 1 Noyce RS, et al.

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Vial

DECEMBER 11, 2023

The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Related but genetically diverse virus variants can occur within the same infected patient, which may lead to quasispecies and resistance to antibody and T-cell-mediated immune responses.

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg). 1-4 The U.S. We understand the devastating impact this can have on people’s lives. Source link: [link] nvestor.lilly.com/.

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The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition.

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The Pharma Data

SEPTEMBER 15, 2020

Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allows for the enrollment of new populations. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1.

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. FDA-approved quadrivalent meningococcal vaccine indicated for all patients above 2 years of age, was launched in the U.S. The target action date for the FDA decision is October 21, 2021.

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The Pharma Data

AUGUST 3, 2021

The FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The delay is related to the FDA’s ongoing assessment of JAK inhibitors. Retevmo was approved by the FDA and launched in the U.S. Key Events Over the Last Three Months Regulatory. revenue of $22.5

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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

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

JULY 21, 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

MAY 6, 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) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

MARCH 11, 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) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Bahrain, and Canada. Source link.

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The Pharma Data

SEPTEMBER 8, 2020

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

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The Pharma Data

SEPTEMBER 8, 2020

FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines.

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The Pharma Data

DECEMBER 27, 2020

CytoDyn announced a treating physician received authorization from the FDA to administer leronlimab for a COVID-19 patient under emergency eIND. It is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory diseases. platforms and the human GM-CSF cytokine.

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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

SEPTEMBER 9, 2020

Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. and Germany as well as animal immunogenicity studies.

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Codon

MARCH 26, 2023

Link *Design of Four Small-Molecule-Inducible Systems in the Yeast Chromosome, Applied to Optimize Terpene Biosynthesis. Link A generalizable nanopore sensor for highly specific protein detection at single-molecule precision. Link Top FDA official: Agency needs to start using accelerated approval for gene therapies.

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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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Government Vaccine Clinical Trials Licensing 52

Codon

APRIL 16, 2023

Skin microbes can trigger strong immune responses. These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. million ($1.58

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