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 96

FDA Approval Antibody Clinical Trials Clinical Trials 96

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Global President, Vaccines, Pfizer.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

XTalks

JANUARY 6, 2023

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS). Briumvi (ublituximab-xiiy) Clinical Trial Results.

FDA Approval 94

FDA Approval Clinical Trials Clinical Trials Antibody 94

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

Drug Delivery Systems 98

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

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 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

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 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

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 98

FDA Approval Drugs Antibody Trials 98

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 26, 2022

The treatment is indicated for such patients who had received four or more previous lines of therapy, including an immunomodulatory drug, proteasome inhibitor and anti-CD38 monoclonal antibody. Based on the response rate from a trial, the regulatory agency approved the indication under an accelerated approval process.

Antibody 130

Antibody FDA Approval Clinical Trials Clinical Trials 130

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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 Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Enhertu Trial Data. The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

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

Drug Discovery World

DECEMBER 22, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients.

Drugs 52

Drugs Antibody FDA Approval Clinical Trials 52

XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

Vaccination 98

Vaccination Vaccine FDA Approval Protein 98

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc.,

Trials 111

Trials Clinical Trials Clinical Trials FDA Approval 111

Drug Discovery World

DECEMBER 21, 2023

Other biotechnologies coming to the fore this year were antibody-drug conjugates and CRISPR gene editing. Regulatory issues and diversity in clinical trials were also important in 2023, as well as the role that artificial intelligence tools like ChatGPT might play.

Gene Therapy 59

Gene Therapy Gene Antibody FDA Approval 59

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. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month.

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

The Pharma Data

NOVEMBER 16, 2020

The same DSMB also oversees the additional OWS-supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates. principal investigator of the NIAID-funded Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston; Lindsey R. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Bioengineer

JULY 23, 2021

MUSC Hollings Cancer Center part of promising clinical trial for aggressive lymphoma. MUSC Hollings Cancer Center was one of 28 clinical sites around the world that participated in the LOTIS-2 trial to test the efficacy of Loncastuximab tesirine, a promising new treatment for aggressive B-cell lymphoma. Original Source.

Trials 52

Trials Antibody Drugs Clinical Trials 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

The Pharma Data

DECEMBER 17, 2020

An Fc-engineered monoclonal antibody targeting the HER2 oncoprotein, MARGENZA offers hope for patients who have received two or more prior anti-HER2 regimens, with at least one being for metastatic disease. The FDA approval of Klisyri is a significant milestone for Athenex. Athenex, Inc.

FDA Approval 52

FDA Approval Genome Genomics Production 52

Pharmaceutical Technology

FEBRUARY 24, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Recombinant DNA Technology 100

Recombinant DNA Technology Production Antibody FDA Approval 100

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 52

FDA Approval Drugs Sales Development 52

Delveinsight

NOVEMBER 26, 2020

About 35% of the animals were cleared of their tumors as reported in Science Translational Medicine. Urovant’s vibegron fails Irritable bowel syndrome phase 2 trial. A phase 2a clinical trial of vibegron of Urovant in Irritable bowel syndrome (IBS) patients has flunked primary endpoint. Clancy, M.D.,

Antibody 79

Antibody Trials Drugs Engineer 79

The Pharma Data

AUGUST 28, 2020

The top 10 news stories this week are focused on coronavirus vaccines and treatments, as China is set to move ahead with human testing of a potential vaccine that has been created using insect cells, while AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100