pharmaphorum

OCTOBER 4, 2022

Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test becomes the only FDA approved companion diagnostic indicated to aid assessment of HER2 low-metastatic breast cancer patients. HER2 is a receptor protein that accelerates cancer cell growth.

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FDA Approval Protein Antibody Engineer 105

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

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Antibody FDA Approval Clinical Trials Clinical Trials 246

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

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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

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FDA Approval Drugs Gene Trials 99

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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FDA Approval Genetics Gene Therapy Gene 105

XTalks

NOVEMBER 26, 2024

This progressive disease occurs when misfolded transthyretin (TTR) proteins form amyloid deposits in the heart, leading to cardiac dysfunction. Attruby offers a more potent option , following Pfizer’s tafamidis (Vyndaqel and Vyndamax), the first therapy and TTR stabilizer approved to treat ATTR-CM.

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Genetic Disease Genetics Protein Clinical Development 105

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.

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FDA Approval Life Science Production Trials 98

XTalks

OCTOBER 25, 2022

The FDA clearance is the first for tremelimumab, which faced an uphill battle after having suffered several failures in trials for other cancer types over the past two decades of its development, including non-small cell lung cancer, head and neck cancer and bladder cancer.

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FDA Approval Trials Drugs Immune Response 98

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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FDA Approval Bacteria Trials Protein 95

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?

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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.

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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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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.

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FDA Approval Drugs Licensing Licensing 105

XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

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FDA Approval Antibody Drugs Protein 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.

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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.

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FDA Approval Antibody Sales Protein 66

pharmaphorum

SEPTEMBER 16, 2022

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Kim recognised then, he said, that better tools for medicine needed to be developed, and that they still do.

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pharmaphorum

MARCH 29, 2021

The modified cells recognise and bind to B-cell maturation antigen (BCMA), a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of cells expressing it. The delay was caused by coronavirus restrictions delaying the site inspections necessary for approval.

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FDA Approval Genetics Protein Antibody 85

XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis.

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FDA Approval Development Containment Licensing 98

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.

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FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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Gene Therapy Gene FDA Approval In-Vivo 98

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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pharmaphorum

DECEMBER 1, 2021

The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition. The post Sanofi snaps up acne vaccine developer Origimm Bio appeared first on.

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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.

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FDA Approval Drugs Gene Therapy Protein 59

pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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Antibody Protein Vaccination Vaccine 128

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

Pharmaceutical Technology

FEBRUARY 13, 2023

Gene therapies are an attractive way of targeting the underlying genetic mutations, but traditional approaches cannot be used while targeting mutations for Dravet Syndrome, forcing researchers to develop new ways. To tackle this, companies have developed different ways to focus on the gene.

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Research Gene Gene Therapy Genome 264

XTalks

MAY 10, 2022

Researchers at the University of Manchester have developed a new blood test that can help diagnose ovarian cancer faster and more accurately in women, particularly those under the age of 50, using a newer ovarian cancer biomarker. The test includes the use of the emerging ovarian cancer biomarker, human epididymis protein 4 (HE4).

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Research Development Clinical Trials Clinical Trials 105

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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Development Vaccine Vaccination Production 101

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals stated that the fast-track designation enables increased communication with the regulator across the development cycle of the gene therapy. Fast-track status also offers the potential for expedited approval of RP-A601 and permits a rolling review of the biologic licence application.

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Gene Therapy Gene FDA Approval Trials 147

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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Vaccination Vaccine Antibody Development 162

XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A While most people usually recover within a few weeks, infants and older adults are at a higher risk of developing severe complications. percent and severe RSV-associated LRTD by 94.1

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Vaccination Vaccine FDA Approval Protein 98

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).

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Protein Regulation FDA Approval Licensing 105