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. It is already approved for three other diseases, and EoE is the first gastrointestinal disease included in this group.

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FDA Approval Antibody Clinical Trials Clinical Trials 105

Drug Discovery World

NOVEMBER 14, 2023

DDW’s Megan Thomas looks at how different diseases will benefit from the success of therapeutic antibodies. Cancer Monoclonal antibodies (mAbs) are a type of targeted drug therapy, and as such are often used to treat cancer. This is not only made clear by the fact that the global cancer mAbs market size was valued at $55.6

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Antibody Development FDA Approval Trials 59

XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

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Sales Drugs Antibody FDA Approval 147

XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

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Clinical Trials Clinical Trials FDA Approval Trials 59

Pharmaceutical Technology

AUGUST 23, 2022

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. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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Vaccination Vaccine Gene Therapy Protein 130

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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FDA Approval Drug Delivery Doctors Doctor 52

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

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Sales Drugs Antibody FDA Approval 130

Drug Discovery World

JUNE 10, 2024

The US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than Covid-19.”

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Vaccination Vaccine FDA Approval Clinical Trials 59

The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. . CHENGDU, China , Feb. S-Trimer is intended to be adjuvanted.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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FDA Approval Clinical Trials Clinical Trials Nurses 64

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. aiming to end the HIV epidemic by 2030.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). TROP2 is a protein that is widely present in most tumors associated with NSCLC. This antibody guides the therapy to the cancer.

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Antibody Clinical Trials Clinical Trials Trials 59

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

MAY 24, 2024

.” XTALKS WEBINAR: AI-based Antibody Therapeutics Developability Assessment and Its Engineering Live and On-Demand: Friday, June 21, 2024, at 10am EDT (4pm CEST/EU-Central) Register for this webinar today to learn how AI can be used to improve developability screening of antibody therapeutics and optimization of antibody candidates.

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Antibody Clinical Trials Clinical Trials Trials 52

The Pharma Data

DECEMBER 17, 2020

Lupus causes the production of proteins called autoantibodies in the immune system, which attack tissues and organs, including the kidneys. There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). Athenex, Inc.

FDA Approval 52

FDA Approval Genome Genomics Production 52

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.

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Antibody Production Manufacturing Clinical Trials 52

XTalks

MAY 1, 2023

Today marks an important moment in ALS research as Qalsody is the first ALS treatment approved based on a biomarker,” said Jean Swidler, chair of Genetic ALS & FTD: End the Legacy, in Biogen’s press release. Reduction in these two biomarkers in response to tofersen is believed to predict clinical benefit for patients.

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FDA Approval Gene Genetics Protein 89

XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US.

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Vaccination Vaccine Immune Response Protein 59

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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Antibody Vaccination Vaccine Trials 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

Antibody 52

Antibody Trials Production Clinical Trials 52

pharmaphorum

JULY 13, 2021

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. All told, the deal could be worth up to $1.2

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Gene Silencing Sales Gene Editing Clinical Trials 98

XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

FDA Approval 52

FDA Approval Production Research Doctors 52

XTalks

MAY 10, 2023

GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE. What’s special about Benlysta is that it was the first and only approved biologic for SLE in over five decades. What Is the Theme of World Lupus Day 2023?

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Drugs Clinical Trials Clinical Trials 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. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. and globally.”.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 14, 2022

Roche’s Genentech division has reported disappointing top-line results from its highly-anticipated phase 3 trial of gantenerumab in early Alzheimer’s disease, in yet another setback for an amyloid-targeting drug. Study participants in GRADUATE 1 and 2 treated with gantenerumab showed a slowing of clinical decline of -0.31

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Trials Drugs Antibody FDA Approval 52

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. This approach allowed them to find disease conditions similar to COVID-19 for which approved treatments were available. The list also included melatonin.

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Research Hormones Protein Regulation 98

The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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Clinical Development Vaccination Vaccine Development 52

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

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Vaccination Vaccine Antibody Protein 52

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

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Marketing Antibody Drugs Sales 85

XTalks

MAY 2, 2023

In December 2021, AstraZeneca and Amgen’s Tezspire (tezepelumab) was approved by the FDA for patients 12 years of age and older with severe asthma that is not controlled by their current asthma medicine. Tezspire is the first treatment for asthma that targets thymic stromal lymphopoietin, a protein involved in airway inflammation.

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Protein FDA Approval Clinical Trials Clinical Trials 109