Pharmaceutical Technology

APRIL 24, 2023

Researchers may develop nanodrugs due to their smaller surface area to allows drugs to dissolve faster, or nanoparticles may encapsulate drugs, so they last longer in the body. Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages.

Drug Delivery 147

Drug Delivery Vaccine Vaccination Research 147

XTalks

DECEMBER 29, 2023

Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

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. Tzield is administered as an intravenous 30-minute infusion once daily for 14 consecutive days.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. If approved, it would become the first PD-1 drug approved in the indication. Its well-configured, a true PD-1 inhibitor and an ideal partner for antibody-drug conjugates (ADCs), he said.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

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. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

FDA Approval 102

FDA Approval Vaccine Vaccination Clinical Trials 102

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. If approved, it would become the first PD-1 drug approved in the indication. Its well-configured, a true PD-1 inhibitor and an ideal partner for antibody-drug conjugates (ADCs), he said.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

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.

Development 161

Development Production Immune Response Licensing 161

XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The drug is the first CGRP receptor antagonist in a nasal spray formulation. Read the full articles here: Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results.

Life Science 40

Life Science FDA Approval Vaccine Vaccination 40

XTalks

JULY 31, 2024

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

Pharmaceutical Technology

APRIL 17, 2023

The Fc region interacts with the cell surface receptors to cause the protective immune response. In December 2021, the US Food and Drug Administration (FDA) approved argenx’s Vyvgart for the treatment of myasthenia gravis in December 2021, marking the company’s first approval.

Antibody 130

Antibody Engineer FDA Approval Development 130

pharmaphorum

APRIL 26, 2022

The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones.

Containment 115

Containment Development Production Drugs 115

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).

Life Science 52

Life Science Drug Delivery Systems Vaccine Vaccination 52

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).

Drugs 59

Drugs FDA Approval Production Immune Response 59

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. .

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials.

FDA Approval 52

FDA Approval Immune Response Drug Delivery Drugs 52

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.

Vaccine 59

Vaccine Vaccination Immune Response Protein 59

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.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Meanwhile, drugs targeting TIM-3, LAG3, VISTA and STING also coming through development.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

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.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

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

Immune Response 52

Immune Response Antibody FDA Approval Trials 52

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. S-Trimer is intended to be adjuvanted.

Vaccine 52

Vaccine Vaccination Immune Response Protein 52

XTalks

JULY 14, 2021

The studies have shown that robust immune responses are achieved when a Pfizer vaccine dose is followed by a dose of AstraZeneca. And in turn, the question’s context was Pfizer’s recent announcement of seeking FDA approval for a third booster dose of its COVID-19 vaccine. And the science backs this.

Vaccine 98

Vaccine Vaccination Immune Response FDA Approval 98

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. Stelara Clinical Trial Results. Stelara is a human IgG1? in a press release.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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.),

Marketing 52

Marketing Sales FDA Approval Antibody 52

XTalks

SEPTEMBER 23, 2021

one month after administration of the second dose, which indicates a strong immune response. Pfizer and BioNTech say they plan to promptly share the data with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators. This was non-inferior, or comparable, to the GMT of 1146.5

Vaccine 98

Vaccine Vaccination Trials Antibody 98

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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. In the U.S.,

Vaccine 52

Vaccine Vaccination Immune Response Antibody 52

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. 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

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. In early 2021, the FDA approved Pfizer’s Panzyga for the treatment of CIDP.

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

XTalks

MAY 24, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in patients who have experienced disease progression after platinum-based chemotherapy. About 40 percent of patients saw significant shrinkage.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

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.

Vaccine 52

Vaccine Vaccination Immune Response Protein 52

XTalks

JUNE 9, 2022

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. The drug was well-tolerated by patients except for two adverse events that were deemed unrelated to the therapy.

Trials 52

Trials Antibody Genetics Gene 52

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic.

Vaccine 98

Vaccine Vaccination Immune Response Manufacturing 98

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

Trials 98

Trials Gene Hormones Clinical Trials 98

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. .

Development 52

Development DNA Clinical Trials Clinical Trials 52

XTalks

JUNE 10, 2024

Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Immune Response 52

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

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52