XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

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Drug Delivery Drugs Immune Response Allergies 111

XTalks

DECEMBER 30, 2024

has announced promising Phase IIb results for cenerimod, an investigational drug targeting immune system dysfunction in moderate-to-severe systemic lupus erythematosus (SLE). SLE is an autoimmune disease where the immune system attacks healthy tissues, causing inflammation, pain and potential organ damage. Viatris Inc.

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Immune Response Gene Expression Drugs Trials 52

XTalks

DECEMBER 20, 2024

The US Food and Drug Administration (FDA) has approved Celltrions Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for the treatment of several immune-mediated diseases. By blocking these inflammatory pathways, it helps manage overactive immune responses in conditions like psoriasis and Crohns disease.

FDA Approval 52

FDA Approval Immune Response Antibody Marketing 52

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.

Life Science 52

Life Science Vaccine Vaccination Immune Response 52

XTalks

NOVEMBER 12, 2024

Research is focused on discovering biomarkers for early detection, developing new drug therapies and exploring immunotherapy options to help the body’s immune system recognize and attack cancer cells. In a small trial, half of the participants exhibited strong anti-tumor immune responses.

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Research FDA Approval Trials Clinical Trials 105

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

AUGUST 8, 2022

Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash.

Immune Response 98

Immune Response Antibody Life Science Engineer 98

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.

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

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.

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Development Drugs Immune Response Life Science 71

pharmaphorum

APRIL 28, 2021

Today, most drug discovery programmes begin with the identification and validation of disease modifying biological targets. Text mining was also able to highlight new insights into the mechanisms of pancreatic cancer’s immune evasion, which refers to cancer cells’ ability to evade an immune response.

Immune Response 105

Immune Response Life Science Genome Genomics 105

XTalks

OCTOBER 11, 2024

Approved by the US Food and Drug Administration (FDA) in May 2023, Arexvy is designed to prevent lower respiratory tract disease (LRTD) caused by RSV in older adults. No new safety issues emerged over the course of the three seasons. When compared to other approved RSV vaccines for older adults, Arexvy shows some key differences.

Vaccine 103

Vaccine Vaccination Immune Response Trials 103

XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. According to a November 2023 readout, Capvaxive also elicited superior immune responses for ten of the 11 serotypes not covered by Prevnar 20.

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FDA Approval Vaccine Vaccination Life Science 108

Pharmaceutical Technology

NOVEMBER 22, 2022

The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. billion towards the “pandemic-busting plan”, which involves the investigation of rapid response vaccine technologies. The UK Government is behind this effort.

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Manufacturing Vaccine Vaccination RNA 130

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

pharmaphorum

AUGUST 27, 2020

The Biotechnology and Biological Sciences Research Council (BBSRC), part of UK Research and Innovation (UKRI), works with universities, research organisations, businesses, charities, and government to develop a supportive ecosystem. Other university cities such as Nottingham and Cardiff are also prominent. COVID-19 sparks change.

Vaccination 122

Vaccination Vaccine Life Science Clinical Trials 122

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.

Vaccine 105

Vaccine Vaccination Immune Response Trials 105

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.

Vaccine 144

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

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. percent in the placebo group.

FDA Approval 111

FDA Approval Gene Therapy Gene Clinical Trials 111

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

XTalks

JULY 26, 2023

The US Food and Drug Administration (FDA) has granted approval to Daiichi Sankyo’s Vanflyta (quizartinib) for newly diagnosed patients with FMS-like tyrosine kinase 3 receptor-internal tandem duplication ( FLT3 -ITD) positive acute myeloid leukemia (AML). The drugs target other, non-ITD mutations in the FLT3 receptor.

FDA Approval 98

FDA Approval Immune Response Drugs Trials 98

XTalks

JUNE 24, 2022

The US Food and Drug Administration (FDA) has authorized the use of Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines for children as young as six months old, a much-awaited decision for some parents with young children.

Vaccine 98

Vaccine Vaccination Immune Response Trials 98

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

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

JULY 8, 2021

The IL-6 receptor antagonists are used to treat rheumatoid arthritis and include drugs such as Roche’s Actemra (tocilizumab) and Regeneron’s Kevzara (sarilumab). The WHO added the class of drugs to its patient care guidelines, deeming the medications to be a lifesaving COVID-19 treatment in combination with corticosteroids.

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Doctor Doctors Drugs Manufacturing 98

XTalks

OCTOBER 25, 2022

While the results are positive, they don’t quite measure up to the combo of PD-L1 blocker Tecentriq and anti-vascular endothelial growth factor (anti-VEGF) drug Avastin, which together have been shown to cut the risk of death by 42 percent in trials. The company said it will disclose Imjudo’s price in the next couple of days.

FDA Approval 98

FDA Approval Trials Drugs Immune Response 98

XTalks

OCTOBER 1, 2024

In the context of asthma, this means potentially restoring the immune response in the respiratory tract to better protect against viral infections that often trigger severe asthma symptoms. Ensuring the stability of mRNA drugs without the need for ultra-cold chain requirements was crucial for practical clinical use.

Development 52

Development Drugs Immune Response Protein 52

pharmaphorum

OCTOBER 12, 2022

“We founded Whitelab Genomics after realising the potential to use data, data science, and AI in a more systematic way to develop genomic therapies,” Del Bourgo says. Poulard goes onto add that, “we think that for the last five years digital technologies and AI have demonstrated the strong value they add to the drug discovery process.

Genome 105

Genome Genomics Medicine Development 105

XTalks

JUNE 18, 2021

The RECOVERY trial found that adding REGEN-COV to standard care reduced the risk of death by 20 percent in patients who had not elicited a natural antibody response on their own against SARS-CoV-2, compared with standard care alone. Regeneron has enlisted the help of Roche to help manufacture the antibody drug.

Antibody 75

Antibody Immune Response Trials Clinical Trials 75

XTalks

MAY 4, 2023

As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease. Drug therapy: Other researchers are investigating the use of drugs that could help reduce the immune response to gluten and prevent damage to the small intestine.

Clinical Trials 98

Clinical Trials Clinical Trials Trials 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