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. Results were similar at the higher 0.8

FDA Approval 78

FDA Approval Antibody Immune Response Drugs 78

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

FDA Approval 98

FDA Approval Antibody Drugs Protein 98

XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death.

FDA Approval 94

FDA Approval Trials Drugs Immune Response 94

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 88

FDA Approval Drugs Clinical Trials Clinical Trials 88

XTalks

JUNE 8, 2022

Amgen’s Riabni, a CD20-directed cytolytic antibody and biosimilar to Rituxan, got approval from the FDA on Monday for adults with moderate to severe rheumatoid arthritis. B-cell targeted therapy with the monoclonal antibody Rituxan (rituximab) is used to treat RA. million Americans. Evidence for the Efficacy of Riabni.

FDA Approval 73

FDA Approval Antibody Clinical Trials Clinical Trials 73

XTalks

FEBRUARY 26, 2024

Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure. Xolair is a monoclonal antibody that binds to IgE, a type of antibody in the body that triggers allergic reactions, to block it from binding to its receptors.

Allergies 74

Allergies FDA Approval Drugs Protein 74

Pharmaceutical Technology

OCTOBER 25, 2022

A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins. Imjudo is also a human monoclonal antibody and hinders cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) activity.

Protein 173

Protein Immune Response Antibody FDA Approval 173

Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

Antibody 246

Antibody FDA Approval Clinical Trials Clinical Trials 246

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

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.

FDA Approval 91

FDA Approval Antibody Clinical Trials Clinical Trials 91

pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA.

FDA Approval 69

FDA Approval Protein Trials Packaging 69

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 79

FDA Approval Life Science Clinical Trials Clinical Trials 79

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.

FDA Approval 85

FDA Approval Genetics Protein Antibody 85

XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. How Does Rystiggo (Rozanolixizumab) Work?

FDA Approval 91

FDA Approval Antibody Protein Engineer 91

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

pharmaphorum

AUGUST 6, 2020

This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term. Blenrep is also set for approval in Europe in the coming months after a positive opinion from the CHMP scientific committee at the end of last month. of patients in the cohort.

FDA Approval 87

FDA Approval Antibody Drugs Packaging 87

pharmaphorum

FEBRUARY 11, 2021

ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role in the development of AD dementia. It remains to be seen of course if that antibody response translates into an effect on symptom progression.

Antibody 128

Antibody Protein Vaccination Vaccine 128

Pharmaceutical Technology

NOVEMBER 13, 2022

A human monoclonal antibody (mAb), Imfinzi attaches to the PD-L1 protein and hinders its interaction with the PD-1 and CD80 proteins, preventing the immune-evading strategy of the tumour. Imjudo (tremelimumab) is also a mAb that acts on the cytotoxic T-lymphocyte-associated protein 4’s (CTLA-4) activity.

Protein 130

Protein FDA Approval Antibody Trials 130

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

Pharmaceutical Technology

FEBRUARY 21, 2023

Currently, there are no approved treatments for CHAPLE, a life-threatening hereditary immune disease caused by an overactivation of the complement system. The investigational, fully human monoclonal antibody, Pozelimab has been designed to block the complement factor C5 activity.

Antibody 130

Antibody FDA Approval Licensing Licensing 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.

FDA Approval 52

FDA Approval Drug Delivery Development Doctors 52

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 The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The F-protein facilitates the fusion of the virus with the membrane of the host cell. billion by 2028.

Vaccination 94

Vaccination Vaccine FDA Approval Protein 94

XTalks

OCTOBER 23, 2024

Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN. IgAN, also known as Berger’s disease, occurs when IgA antibodies build up in the kidneys, leading to inflammation.

Trials 75

Trials Clinical Trials Clinical Trials Antibody 75

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. According to the Centers for Disease Control and Prevention (CDC) , 45.8 This is a significant increase compared to the 2021–20 season when the rate was 28.3

Vaccination 162

Vaccination Vaccine Antibody Development 162

XTalks

AUGUST 2, 2022

Benlysta (belimumab) is a biologic therapy, a human monoclonal antibody. Autoreactive B cells release antibodies like other B cells do, except they release autoantibodies. B cells require a specific protein for growth called BLyS (B-lymphocyte stimulator), which is implicated in the pathogenesis of SLE.

FDA Approval 69

FDA Approval Antibody Bacteria Protein 69

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

Antibody 52

Antibody Immune Response Production Engineer 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.

Sales 147

Sales Drugs Antibody FDA Approval 147

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,

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

APRIL 28, 2023

Its scope includes Syngene providing integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. until 2026. Syngene’s collaboration with Zoetis started in 2011.

Manufacturing 130

Manufacturing Antibody Clinical Supply Protein 130

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.

Sales 130

Sales Drugs Antibody FDA Approval 130

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. director of the FDA’s Center for Drug Evaluation and Research. The issuance of an EUA is different than an FDA approval. Today, the U.S.

Antibody 40

Antibody Vaccination Vaccine FDA Approval 40

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 Genomics Genome Production 52

The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. Overall, 311 patients were randomized and treated with RIABNI, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US).

FDA Approval 52

FDA Approval Antibody Medicine Manufacturing 52

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.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

NOVEMBER 5, 2021

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. billion in peak annual sales if it gets approved for all its target indications.

Trials 105

Trials Protein Antibody FDA Approval 105

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.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52