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 97

FDA Approval Antibody Immune Response Drugs 97

Drug Discovery World

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). It is directed to Nectin-4, a protein highly expressed in bladder cancer.

FDA Approval 52

FDA Approval Antibody Trials Drugs 52

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.

FDA Approval 96

FDA Approval Antibody Clinical Trials Clinical Trials 96

Drug Discovery World

MARCH 1, 2023

Antiverse has successfully identified functional antibody clusters targeting two G-protein-coupled receptors (GPCRs), both displaying versatile binding profiles and nanomolar affinity. The company has raised $3 million in funding, which will enable in-house development of the antibodies showing the highest affinity blocking function.

Antibody 52

Antibody Development In-Vivo FDA Approval 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. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 147

Sales Drugs Antibody FDA Approval 147

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. At the time, aducanumab was the first new Alzheimer’s drug in nearly 20 years.

Antibody 59

Antibody Development FDA Approval Trials 59

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.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

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. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 130

Sales Drugs Antibody FDA Approval 130

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. Dupixent is approved for patients 12 years of age or older (weighing over 40 kg) at a dose of 300 mg per week. On Friday, Regeneron Pharmaceuticals, Inc.

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

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

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).

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

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

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

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. C5 is a protein that is involved in the activation of the complement system.

Antibody 130

Antibody FDA Approval Licensing Licensing 130

pharmaphorum

MARCH 29, 2021

Abecma’s review was delayed after the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant step forward in the treatment of this incurable condition. The delay was caused by coronavirus restrictions delaying the site inspections necessary for approval.

FDA Approval 62

FDA Approval Genetics Protein Antibody 62

XTalks

AUGUST 2, 2022

On July 27, 2022, GSK announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as an intravenous treatment for lupus and active lupus nephritis (LN) in children between the ages of 5 and 17 who are receiving standard therapy. How Benlysta (belimumab) Works.

FDA Approval 94

FDA Approval Antibody Bacteria Protein 94

Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

Protein 130

Protein FDA Approval Antibody Trials 130

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 127

Antibody Protein Vaccination Vaccine 127

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.

FDA Approval 52

FDA Approval Drug Delivery Doctors Doctor 52

XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

FDA Approval 52

FDA Approval Drugs Antibody Medicine 52

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

XTalks

FEBRUARY 20, 2024

have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for sibeprenlimab, an investigational drug intended for treating immunoglobulin A (IgA) nephropathy, commonly known as Berger’s disease. Consequently, this damage causes blood and protein leakage into the urine.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an 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

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

Drug Discovery World

AUGUST 24, 2023

It is approved in adult patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5%

Antibody 52

Antibody FDA Approval Protein Drugs 52

Drug Discovery World

FEBRUARY 7, 2024

Professor Jonathan Blackburn, Chief Scientific Officer (CSO) of Sengenics, featured in a sponsored DDW Sitting Down With podcast to discuss the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics’ new i-Ome Discovery chip, and more. He elaborates in the podcast.

Medicine 59

Medicine Protein FDA Approval DNA 59

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. “We This antibody guides the therapy to the cancer.

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

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. The first-in-class drug also being tested in another rare kidney disease, idiopathic membranous nephropathy, in phase 2.

Trials 104

Trials Protein Antibody FDA Approval 104

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. First the bad news.

Trials 52

Trials Drugs Antibody FDA Approval 52

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) had several approvals this week. Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. GlaxoSmithKline. GSK announced on Thursday that the U.S.

FDA Approval 52

FDA Approval Genome Genomics Production 52

XTalks

JANUARY 8, 2024

Calliditas Therapeutics AB announced that the US Food and Drug Administration (FDA) has granted full approval for Tarpeyo (budesonide) delayed-release capsules, aimed at diminishing kidney function loss in adults diagnosed with primary immunoglobulin A nephropathy (IgAN) who are susceptible to disease advancement. mL/min/1.73

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Nurses 64

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. How Does Qalsody Work?

FDA Approval 89

FDA Approval Gene Genetics Protein 89

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.

Drugs 52

Drugs Clinical Trials Clinical Trials Antibody 52

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

Gene Therapy 98

Gene Therapy Gene FDA Approval Antibody 98