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 83

Allergies FDA Approval Drugs Protein 83

XTalks

SEPTEMBER 16, 2024

The shift towards monoclonal antibodies, including Ocrevus, has also contributed to this growth. Genentech is pursuing over 30 ongoing trials — including a Phase I study on transferring anti-CD20 antibodies across the blood-brain barrier ­— to better understand disease progression and improve patient outcomes in multiple sclerosis.

FDA Approval 59

FDA Approval Drug Delivery Antibody Drugs 59

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 83

FDA Approval Antibody Clinical Trials Clinical Trials 83

XTalks

OCTOBER 22, 2021

Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

FDA Approval 97

FDA Approval Production Insulin Antibody 97

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

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

FDA Approval 89

FDA Approval Life Science Clinical Trials Clinical Trials 89

XTalks

MARCH 9, 2023

IgA nephropathy, also known as Berger’s disease , is a rare kidney disease that occurs due to build-up of the antibody immunoglobulin A in the kidneys. The efficacy data used for the FDA-approved label is based on post-hoc sensitivity analysis evaluating only the first 281 randomized patients in the trial.

FDA Approval 96

FDA Approval Drugs Clinical Trials Clinical Trials 96

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. Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo is administered as a single dose with Imfinzi, followed by Imfinzi infusions every four weeks.

FDA Approval 98

FDA Approval Trials Drugs Immune Response 98

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

NOVEMBER 15, 2023

Related: FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration The FDA approval of Ixchiq was based on data from two clinical studies conducted in North America. Almost all study participants who received the vaccine achieved an antibody level determined to be protective in non-human primates.

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

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 25, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab’s Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two or more lines of systemic therapy.

Antibody 91

Antibody FDA Approval Drugs Trials 91

XTalks

JANUARY 5, 2021

These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity. Eli Lilly’s bamlanivimab and Regeneron’s monoclonal antibody cocktail REGEN-COV2 which consists of two monoclonal antibodies, casirivimab and imdevimab, were approved in 2020 for use in the treatment of COVID-19 patients.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

Life Science 93

Life Science Vaccination Vaccine Trials 93

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 100

FDA Approval Antibody Clinical Trials Clinical Trials 100

XTalks

NOVEMBER 3, 2021

The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science Drug Delivery Systems Vaccination Vaccine 52

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC).

FDA Approval 52

FDA Approval Vaccine Vaccination Sales 52

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. Photo courtesy of AbbVie. . They are chronic and progressive, meaning they will worsen over time without proper intervention.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials DNA 52

XTalks

JULY 28, 2021

In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at the Alzheimer’s Association International Conference (AAIC) 2021 this week.

Life Science 52

Life Science FDA Approval Drugs Antibody 52

XTalks

NOVEMBER 26, 2024

Keytruda (Pembrolizumab) Keytruda 2023 sales: $25.011 billion Company/developer: Merck Date of first US Food and Drug Administration (FDA) approval: September 4, 2014 Indications Keytruda is FDA-approved for: Unresectable or metastatic melanoma.

Sales 97

Sales FDA Approval Drugs Marketing 97

XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

FDA Approval 97

FDA Approval Drugs Antibody Trials 97

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

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

Life Science 52

Life Science Medicine RNA Vaccine 52

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. The pain relief effects were sustained for up to 48 hours.

FDA Approval 92

FDA Approval Trials Drugs Sales 92

XTalks

OCTOBER 6, 2020

FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial. Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both the soluble and transmembrane bioactive forms of human TNF-alpha.

FDA Approval 61

FDA Approval Clinical Trials Clinical Trials Trials 61

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. How Benlysta (belimumab) Works. The autoantibodies do not fight actual infection or bacteria, but rather the normal tissue in the body.

FDA Approval 78

FDA Approval Antibody Bacteria Protein 78

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

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 84

Trials Clinical Trials Clinical Trials Antibody 84

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.

FDA Approval 97

FDA Approval Antibody Protein Engineer 97

XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Immunotherapy techniques use monoclonal antibodies to target malignant cells. Product logo and product image courtesy of Bristol Myers Squibb.

FDA Approval 52

FDA Approval Gene Therapy Antibody Gene 52

XTalks

FEBRUARY 29, 2024

In a statement , the company said it will discontinue Aduhelm to focus efforts on its other amyloid beta-directed antibody Leqembi (lecanemab) for Alzheimer’s and focus on developing other new treatments. After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

FDA Approval 92

FDA Approval Gene Therapy Antibody Gene 92

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. In October 2023, the bispecific antibody got a label expansion to retinal vein occlusion.

FDA Approval 93

FDA Approval Clinical Trials Clinical Trials Sales 93

XTalks

JUNE 5, 2023

Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease,” said Edward E. The global RSV vaccine and antibody market is expected to reach $2.56

Vaccination 98

Vaccination Vaccine FDA Approval Protein 98

XTalks

DECEMBER 28, 2023

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Currently, there are no approved non-surgical treatments for pregnancies at high risk of this condition.

Trials 88

Trials Clinical Trials Clinical Trials Antibody 88

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Karl Ziegelbauer, Almirall’s chief scientific officer, in the press release.

Dermatology 87

Dermatology Antibody Clinical Trials Clinical Trials 87