XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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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. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S.

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XTalks

MARCH 8, 2024

The US Food and Drug Administration (FDA) has granted approval to two of Sandoz’s biosimilars to Amgen’s blockbuster bone drugs Prolia (denosumab) and Xgeva (denosumab). Jubbonti is the first interchangeable biosimilar approved to treat osteoporosis and increase bone mass.

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Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study. In trying to fix the problem, the immune system causes even more damage,” said Evseenko.

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XTalks

JUNE 5, 2023

Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD).

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene.

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XTalks

JUNE 15, 2022

Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). protein that triggers the immune system to generate antibodies against the virus.

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pharmaphorum

APRIL 20, 2022

per-share deal values CheckMate at around $250 million, and revolves around the toll-like receptor-9 (TKR9) agonist, which is in clinical testing in combination with other drugs for melanoma and non-melanoma skin cancers, as well as head and neck cancer. The $10.50-per-share

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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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). Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.

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XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. The featured speakers will discuss how to facilitate trial participation in rare disease.

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XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Part A involved assessing the safety profile of the drug.

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Children have been the focus of malaria vaccine and drug trials because over 90 percent of deaths attributable to malaria are in African children under the age of five. Moreover, a very strong immune response is needed to fend off the disease.

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The Pharma Data

OCTOBER 28, 2020

(NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron has shared these results with the U.S. combined dose groups; 6.5% placebo; p=0.024). .”

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.

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Delveinsight

SEPTEMBER 8, 2021

The exact cause of SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition, and many studies have revealed a complex genetic basis. The first line of therapy/agents recommended for the Systemic Lupus Erythematosus treatment includes Nonsteroidal anti-inflammatory drugs (NSAIDs) (Naproxen, Celecoxib, etc.),

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. 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.

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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. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

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The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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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 goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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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. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

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Find Me Cure

OCTOBER 13, 2019

Drugs and therapies under study are our hope for the future of healthcare, so taking the time to learn more about them is an investment in your future health as well as the background education you need to make informed decisions about your treatment. Neratinib and tucatinib are such inhibitors being studied in metastatic breast cancer. .

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XTalks

SEPTEMBER 23, 2021

The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old. Results showed that the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 Pfizer Inc. Results for children under the age of five are expected later this year.

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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). In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease.

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XTalks

AUGUST 17, 2020

chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. Treatment vaccines : these boost the immune system responses to target cells.

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Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.

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Pharmaceutical Technology

OCTOBER 25, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), a kind of liver cancer.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

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