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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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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Small Molecule Research Immune Response FDA Approval 52

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

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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Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants primarily help the immune response through the “graft-versus-leukaemia effect,” and we have to manage the “graft versus host effect.” While research to optimise BiTE molecules and refine their capabilities is ongoing, this is where most FDA approvals are taking place as the field is developing so rapidly.

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The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. The microbes deploy them to dismantle the genetic material of infecting viruses, a little like an immune response.

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FDA Approval DNA Therapies Clinical Trials 52

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). News information is not all-inclusive and updates are published once a week on Tuesdays. . .

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

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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

NOVEMBER 9, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Source: Novavax, Inc. . Posted: November 2020.

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The Pharma Data

MARCH 29, 2022

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).

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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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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History.

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Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

AUGUST 17, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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Treatment Immune Response Trials FDA Approval 52

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.

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The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. Source: Novavax, Inc. . Posted: November 2020.

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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. of patients experienced a sustained hemoglobin improvement without transfusions respectively.

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The Pharma Data

DECEMBER 28, 2020

Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition. For more information about the Company, please visit [link].

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The Pharma Data

SEPTEMBER 8, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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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

DECEMBER 18, 2020

After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. Director of the FDA’s Center for Biologics Evaluation and Research.

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The Pharma Data

APRIL 11, 2021

The scientific rationale for using immunotherapy in the neoadjuvant setting is twofold: it presents the earliest opportunity to treat cancer cells that have spread in the body without detection, and the presence of a tumor during immunotherapy treatment may enable a stronger immune response, potentially making the treatment more effective.

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Trials Treatment Clinical Trials Immune Response 52

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. No new safety concerns were identified from the data available.

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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. Geometric Mean Titers (GMT) (95% CI).

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Vaccine Virus Trials Immune Response 52

Vial

DECEMBER 11, 2023

Hepatitis C Virus (HCV) Drug Development There is an urgent need to develop novel, efficient, reliable, and cost-effective diagnostic technologies and therapeutic and immune prophylactic interventions to manage HCV. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs.

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The Pharma Data

NOVEMBER 20, 2020

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. Source: Regeneron. Posted: November 2020.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

They are called immune modulators because they help to minimize the effects of an overactive immune response in some COVID-19 patients. This response, called a “cytokine storm,” can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.

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The Pharma Data

JUNE 30, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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Treatment Trials FDA Approval Disease 52

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Casirivimab and imdevimab injection is not FDA approved for any use. did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk.

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The Pharma Data

FEBRUARY 18, 2022

Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on gastrointestinal immune-mediated diseases. About Ulcerative Colitis. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. About Bristol Myers Squibb.

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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.

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The Pharma Data

DECEMBER 15, 2020

In September, Corbus Pharmaceuticals Holdings announced topline results from its 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc), a rare life-threatening multi-system autoimmune disease for which there are no FDA-approved treatments.

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The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. “The investigational cocktail is now available to indicated high-risk U.S.

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The Anticancer Fund

JUNE 23, 2023

They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. In this small (n=10) proof of concept trial colorectal cancer patients undergoing surgical resection were injected intratumourally with flu vaccine.

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The Pharma Data

JANUARY 29, 2021

Janssen’s Vaccine Technology The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform , which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. i] [link] [ii] The B.1.351

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

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