XTalks

SEPTEMBER 29, 2021

Although the Bad Ad program is primarily directed towards healthcare providers, the general public can also anonymously report dubious ads to the FDA’s Office of Prescription Drug Promotion (OPDP), which runs the program. The data shows that the vaccine is safe, well-tolerated and elicits robust immune responses in this age group.

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Life Science Vaccine Vaccination Immune Response 52

XTalks

NOVEMBER 3, 2021

The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer.

Life Science 52

Life Science Drug Delivery Systems Vaccine Vaccination 52

XTalks

DECEMBER 15, 2021

The drug is the first CGRP receptor antagonist in a nasal spray formulation. The results showed that the vaccine had no serious safety concerns and elicits immune responses against four different strains of the influenza virus. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 40

Life Science FDA Approval Vaccine Vaccination 40

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

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. Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US.

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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

pharmaphorum

MARCH 23, 2021

US biotech Aura Biosciences has closed an oversubscribed financing, raising $80 million to help take its lead virus-like drug conjugate (VDC) for a cancer that affects the eye into late-stage development. The post Aura raises $80m to develop its virus-like cancer drugs appeared first on.

Development 71

Development Drugs Immune Response Life Science 71

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

BioTech 365

OCTOBER 22, 2020

-Proof-of-concept achieved for VY-UC to engineer donor cells without the complexities of gene-editing -Novel platform abrogates cellular immune response and obviates the need for immunosuppressive drugs TAMPA, Fla. & an immuno-centric discovery life science company with a … Continue reading →

Gene Editing 40

Gene Editing Immune Response Life Science Engineer 40

XTalks

JANUARY 8, 2021

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. The depth of the immune response is associated with the duration of protection.

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Vaccine Vaccination Clinical Trials Clinical Trials 144

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

The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. Tiziana Life Sciences January 9, 2020 Press Release ( [link] ). Billion by 2025. and Europe.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. It has been one of Pfizer’s best-selling drugs. Related: GSK’s Vaccine Awareness Campaign Targets Baby Boomers.

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FDA Approval Vaccine Vaccination Immune Response 89

pharmaphorum

JULY 20, 2021

According to some studies, beta may be the most likely to evade immune responses stimulated by the currently available shots as well as some antibody drugs for SARS-CoV-2, and is also thought to be more transmissible. 1.351) variant first identified in South Africa.

Vaccine 98

Vaccine Vaccination Protein Immune Response 98

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

Antibody 102

Antibody Immune Response Radiology Marketing 102

XTalks

MAY 30, 2023

This year, advocates are particularly focusing on lobbying for policy changes that will make MS drugs more affordable and accessible, especially in low-income countries. Drugs that promote remyelination (the process of repairing damaged myelin) are also being developed.

Genetics 98

Genetics Research Immune Response Drugs 98

XTalks

SEPTEMBER 15, 2020

In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.

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Vaccine Vaccination Insulin Trials 103

XTalks

AUGUST 16, 2021

The US Food and Drug Administration (FDA) has amended its emergency use authorizations (EUA) for both the Pfizer and Moderna COVID-19 vaccines to incorporate a third dose for immunocompromised individuals. Related: CDC Backs J&J COVID-19 Shot Amid GBS and Delta Variant Concerns.

Vaccine 104

Vaccine Vaccination Antibody Immune Response 104

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

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

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

XTalks

SEPTEMBER 5, 2023

Finally, addressing the time-consuming and costly transition from non-clinical to clinical development due to difficulties in predicting human immune responses is another issue. Therefore, planned protocols should specify in detail methodologies to be used to evaluate immune responses to vaccination.

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Vaccine Vaccination Development Clinical Trials 96

pharmaphorum

NOVEMBER 29, 2022

T cells are known to mediate anti-tumor immune responses. For that reason, they have become the key target of immune checkpoint therapies, like PD-(L)1 agents. Dr Yang has created several intellectual-property protected inventions, including the hyFc® platform technology and NT-I7 drug candidate. NT-I7 (efineptakin alfa).

Clinical Trials 105

Clinical Trials Clinical Trials Trials Engineer 105

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.

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XTalks

DECEMBER 12, 2023

These therapies consist of thousands of antibodies that are made in the laboratory versus being extracted from plasma, to treat disease with a diverse response, the same way a natural immune system would.

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Medicine Recombinant Antibody Protein Antibody 111

The Pharma Data

JANUARY 3, 2021

Zeldis, who formerly served as Chief Medical Officer (CMO) and Head of Clinical Research, Medical Affairs, and Drug Safety, at Celgene, and CEO of Celgene Global Health, helped guide Celgene’s expansion into one of the biotechnology industry’s most successful companies. . GAITHERSBURG, Md.,

Immune Response 40

Immune Response Clinical Trials Clinical Trials Development 40

XTalks

JULY 14, 2021

And the science backs this. The studies have shown that robust immune responses are achieved when a Pfizer vaccine dose is followed by a dose of AstraZeneca. Several studies support the pairing of the Pfizer and AstraZeneca vaccines, including research from the UK, Spain and Germany. two doses of the same vaccine).

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Vaccine Vaccination Immune Response FDA Approval 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. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

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

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Vaccine Vaccination Trials Antibody 98

XTalks

JUNE 21, 2024

Dr. Bryan began his career at Schering-Plough, engaging in formulation and drug delivery. Unlike traditional therapies that act on the immune cascade after it has been initiated, Revolo’s treatments act at the very beginning of the immune response.

Development 52

Development Immune Response Drugs Regulation 52

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

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. These data showed that drug exposure and efficacy were consistent with previous results from adult trials.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

JANUARY 19, 2021

The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). Its first drug is PHVS416 for HAE, with plans to initiate a Phase II trial this year. It has two drugs in Phase I/II trials: NEXI-001 for acute myeloid leukemia and NEXI-002 for multiple myeloma.

In-Vitro 52

In-Vitro Production Trials Manufacturing 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

XTalks

JUNE 10, 2024

The portrayal opened up the possibility of a life unhindered by the visible signs of psoriasis. 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

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. Ongoing and Future Studies.

Trials 52

Trials Antibody Genetics Gene 52

XTalks

NOVEMBER 10, 2020

The US Food and Drug Administration (FDA) says that for a vaccine to be approved, it must be 50 per cent effective, ideally for preventing the disease, but possibly for only preventing severe disease. The early stage trial is evaluating the safety profile and immunogenicity of the vaccine.

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Vaccine Vaccination Trials Clinical Trials 75