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.

FDA Approval 65

FDA Approval Therapies Treatment Clinical Trials 65

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.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

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.

FDA Approval 52

FDA Approval DNA Therapies Clinical Trials 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52

Vaccine FDA Approval FDA Disease 52

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.

Therapies 64

Therapies Treatment Vaccine FDA Approval 64

Vial

DECEMBER 11, 2023

The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Other inhibitors, currently in different stages of development (including clinical trials ), mainly target viral non-structural proteins or the internal ribosome entry site (IRES). Zhao et al.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. and globally.”.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021.

Vaccine 52

Vaccine Immune Response Virus RNA 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. Data from Rousseau G.F.

Production 131

Production Clinical Trials Trials Therapies 131

The Pharma Data

NOVEMBER 30, 2020

In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 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). CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting.

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

Cutting through the usual red tape and working with an intense sense of purpose, the partnership took a mere matter of weeks to set up its first four clinical trials. Therapeutics Clinical Working Group : Prioritizes therapeutic agents for testing within an adaptive master protocol strategy for clinical research.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

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.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

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.

Vaccine 52

Vaccine Immune Response FDA FDA Approval 52

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.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

The Pharma Data

DECEMBER 28, 2020

. Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B /2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease.

FDA 52

FDA Clinical Trials Drugs Pharmaceutical Companies 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.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

FDA 40

FDA Clinical Trials Vaccine Trials 40

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. The vaccine was 94.1%

Vaccine 52

Vaccine FDA Clinical Trials FDA Approval 52

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.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

Codon

NOVEMBER 3, 2024

Fortunately, some novel preventatives and therapies are in the works, including a vaccine equipped with adjuvants that efficiently prime the immune system and newer antibiotics against which the bacteria have yet to evolve resistance. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

Vaccine 83

Vaccine Trials Therapies Research 83

The Pharma Data

FEBRUARY 18, 2022

“These findings demonstrate important and clinically meaningful responses across multiple key endpoints and build upon our current knowledge of the efficacy and safety profile of Zeposia.”. About Ulcerative Colitis. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. About Bristol Myers Squibb.

Clinical Trials 40

Clinical Trials Treatment Immune Response Disease 40

The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Treatment Immune Response Clinical Trials 52

The Pharma Data

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

FEBRUARY 23, 2022

Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. About VAT08 and VAT02 The Phase 3 trial, VAT08 is evaluating a 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine?

Vaccine 52

Vaccine Virus Trials Immune Response 52

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. Anti-CD40L Antibody.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Anticancer Fund

JUNE 23, 2023

Given the low toxicity associated with this drug, this study is strong support for clinical exploration of the combination of checkpoint inhibition and canagliflozin. In this small (n=10) proof of concept trial colorectal cancer patients undergoing surgical resection were injected intratumourally with flu vaccine.

Drugs 52

Drugs Trials Clinical Trials Treatment 52

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.

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 21, 2020

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.

FDA 40

FDA Clinical Trials Hospitals Production 40

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. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals 52

Hospitals Production Clinical Trials Therapies 52

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.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Clinical Trials 40

The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

Therapies 52

Therapies Clinical Trials Production Treatment 52

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JULY 23, 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.

Treatment 52

Treatment Trials Therapies Disease 52