XTalks

APRIL 9, 2025

Primary IgAN is a rare autoimmune disease in which deposits of IgA provoke glomerular inflammation and excessive protein leakage into the urine. Beyond Vanrafia, Novartis is advancing zigakibart, a subcutaneously administered antiAPRIL monoclonal antibody in PhaseIII development for IgAN.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. TGCT is a rare, non-cancerous tumor that develops inside or near joints.

FDA Approval 59

FDA Approval Drugs Trials Clinical Trials 59

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. to 4,437 yen, reflecting investor confidence.

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Antibody FDA Approval HR Trials 105

Pharmaceutical Technology

NOVEMBER 14, 2022

Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial. binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4. The ADC comprises an FR?-binding

Antibody 246

Antibody FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

JUNE 28, 2022

grant from the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) for developing a Covid-19 oral antiviral drug. They analysed whether various Food and Drug Administration (FDA)-approved drugs acting on the hepatitis C protease could attach and hinder SARS-CoV-2 proteases.

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Development Bioinformatics Drugs Allergies 147

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation. Metzger, CEO of Syndax. “We

FDA Approval 99

FDA Approval Drugs Gene Trials 99

XTalks

APRIL 3, 2024

Approximately ten to 20 percent of patients with PNH may develop extravascular hemolysis (EVH), a condition that causes RBC destruction outside of blood vessels. The RBCs in circulation are marked by proteins in the complement system for removal by the spleen and liver. While Soliris had its market launch 17 years ago with $3.2

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

MARCH 3, 2022

Developed in partnership with Legend Biotech Corp of China, Johnson & Johnson’s cell therapy Carvykti (formerly known as cilta-cel) received approval from the US Food and Drug Administration (FDA) this week for the treatment of multiple myeloma. Both Abecma and Breyanzi got FDA clearance in early 2021.

FDA Approval 98

FDA Approval Life Science Production Trials 98

XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. What is Molluscum Contagiosum?

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

MARCH 9, 2023

The approval was granted for its use as a non-immunosuppressive therapy for the reduction of proteinuria (protein in urine) in IgA nephropathy in adults. Filspari is the first single molecule dual endothelin angiotensin receptor antagonist (DEARA) approved for this indication. g/g and be at risk of rapid disease progression.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JULY 25, 2023

“The approval of Cyfendus vaccine is symbolic of Emergent’s longstanding partnership with the US government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. What Is Anthrax? How Does Cyfendus Work?

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FDA Approval Vaccine Vaccination Antibody 98

XTalks

OCTOBER 22, 2024

transmembrane tight junction protein, which is commonly found in some gastric and GEJ cancers. Vyloy is approved to be used in combination with chemotherapy (fluoropyrimidine- and platinum-based) as a first-line treatment for patients with locally advanced, unresectable or metastatic forms of these cancers.

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

XTalks

OCTOBER 4, 2022

Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malignancies on myelosuppressive anti-cancer drugs. How Does Rolvedon Work?

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. XTALKS WEBINAR: Novel Protein-Like Synthetic Polymers with Superior Properties as Therapeutics, Diagnostics and Targeted Delivery Agents.

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

FDA Approval 66

FDA Approval Sales Antibody Protein 66

XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Gene therapies are expensive and complex to develop.

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Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. The study involved food challenges where participants were given gradually increasing amounts of foods they are allergic to and a placebo ingredient.

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Allergies FDA Approval Drugs Protein 100

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Tyrosine Kinase Inhibitors for Cancer Treatment Tyrosine kinases, or TKs, are a group of signaling molecules that affect multiple downstream proteins.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

pharmaphorum

NOVEMBER 12, 2021

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The tool meanwhile could also be applied to new outbreaks of other novel viral infections as they emerge, according to the scientists.

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Doctor Doctors Drugs Gene Expression 135

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

STAT News

NOVEMBER 23, 2022

Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder , STAT writes. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.

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Gene Therapy FDA Approval Gene Genetics 97

Pharmaceutical Technology

NOVEMBER 1, 2022

An oral inhibitor of exportin 1 (XPO1), Nexpovio works by selectively attaching to hindering the nuclear export protein XPO1. It prevents the tumour suppressor, growth regulatory and anti-inflammatory proteins’ nuclear export, causing their build-up in the nucleus and boosting their anti-cancer activity in the cell.

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Protein FDA Approval Production Licensing 130

XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. Tryngolza works by targeting a protein in the liver, apoC-III, which regulates triglyceride metabolism. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain.

FDA Approval 59

FDA Approval Drugs Clinical Trials Clinical Trials 59

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. point reduction in the placebo arm.

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Drugs Gene Hormones Clinical Trials 317

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Vaccine Vaccination Protein Immune Response 111

pharmaphorum

JANUARY 11, 2023

AbbVie and Anima Biotech have announced that they are collaborating in a deal worth up to over $580 million to discover and develop drugs that modulate mRNA biology for three targets in cancer and immunology. before disease-related proteins are expressed). before disease-related proteins are expressed).

Protein 105

Protein Regulation FDA Approval Licensing 105

Pharmaceutical Technology

AUGUST 23, 2022

On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. 5-adapted bivalent vaccine will be made readily available for shipping.

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Vaccine Vaccination Gene Therapy Protein 130

XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG). How Does Rystiggo (Rozanolixizumab) Work?

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

Pharmaceutical Technology

FEBRUARY 21, 2023

C5 is a protein that is involved in the activation of the complement system. The antibody is developed using the company’s VelocImmune technology. Earlier this month, Regeneron received US FDA approval for its Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants.

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Antibody FDA Approval Licensing Licensing 130

pharmaphorum

MAY 13, 2021

There are already several drugs on the market to treat Duchenne, notably from Sarepta Therapeutics which has three FDA-approved drugs that use “exon skipping” technology. These allow the body to produce a correct version of the misfolded dystrophin protein that is the root cause of DMD.

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Gene Therapy Gene Trials Protein 102

The Pharma Data

APRIL 26, 2022

A drug used to treat asthma and allergies can bind to and block a crucial protein produced by the virus SARS-CoV-2, and reduce viral replication in human immune cells, according to a new study by researchers at the Indian Institute of Science (IISc). Targeting Nsp1 could therefore reduce the damage inflicted by the virus.

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Protein Drugs Allergies FDA Approval 52

XTalks

NOVEMBER 1, 2024

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. Invega Sustenna (Paliperidone Palmitate) Invega Sustenna 2023 sales: $4.115 billion Company/developer: Janssen Pharmaceuticals, Inc.

FDA Approval 85

FDA Approval Drugs Botox Sales 85

Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. Initially centered on Librela®, this agreement paves the way for developing and manufacturing other molecules in the coming years. until 2026. until 2026.

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pharmaphorum

NOVEMBER 5, 2021

Patients whose C3G returned after a transplant also showed significantly reduced C3 protein deposits in kidney biopsies with iptacopan, which is now in a phase 3 trial for C3G called APPEAR-C3G. The post Novartis’ iptacopan hits the mark in rare kidney disease C3G appeared first on.

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Trials Protein Antibody FDA Approval 105

The Pharma Data

AUGUST 13, 2020

NS Pharma has claimed a tentative FDA approval for its Viltepso (viltolarsen) injection in the treatment of Duchenne muscular dystrophy (DMD) in patients who are suitable to receive exon 53 skipping therapy. Mutations in the DMD gene can lead to an absence of the muscle cell protein dystrophin. Matt Fellows. Source link.

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FDA Approval Genetics Protein Gene 52