Clinical Trials

Tony Wood Replaces Hal Barron as GSK’s Chief Executive Officer

by Samantha McGrail

GSK recently appointed Tony Wood as chief executive officer (CSO), replacing current CSO Hal Barron. Wood, a highly respected scientist and one of the world’s pre-eminent chemists, has over 30...

Bristol Myers, Century to Develop Allogeneic Cell Therapies

by Samantha McGrail

Bristol Myers Squibb and Century Therapeutics recently collaborated to develop and commercialize up to four engineered natural killer (iNK) and/or allogeneic cell therapies for hematologic malignancies...

Pfizer’s COVID-19 Vaccine, Pneumococcal Vaccine Helps Older Adults

by Samantha McGrail

Pfizer recently announced positive top-line results from a Phase 3 trial studying its COVID-19 vaccine combined with its pneumococcal 20-valent conjugate vaccine, Prevnar 20. The study, B74710126,...

Real-World Evidence Confirms J&J COVID-19 Vaccine Protection

by Samantha McGrail

Real-world evidence recently confirmed that Johnson & Johnson’sJohnson’s COVID-19 vaccine provides long-lasting protection against breakthrough infections, hospitalizations, and ICU...

Moderna Doses First Participant in Study of EBV mRNA Vaccine

by Samantha McGrail

Moderna recently dosed the first participant in a Phase 1 study of its mRNA vaccine, mRNA-1189, for Epstein-Barr Virus (EBV). The Eclipse study will enroll nearly 270 participants 18 to 30 years of...

Convalescent Plasma Reduces COVID-19 Hospitalizations Nearly 50%

by Samantha McGrail

Convalescent plasma from patients who have recovered from COVID-19 reduced hospitalizations by nearly 50% for outpatients infected with the virus in a nationwide, multicenter clinical trial. Johns...

FDA Approves Two Pediatric Indications For J&J’s Xarelto

by Samantha McGrail

FDA recently approved two pediatric indications for Johnson & Johnson’s direct oral anticoagulant (DOAC), Xarelto. The agency approved the drug to treat venous thromboembolism (VTE) and to...

iQ Group Seeks Approval for Diabetes Care Management Biosensor

by Samantha McGrail

Life Science Biosensor Diagnostics (LSBD), a subsidiary of the iQ Group Global, recently filed an FDA Breakthrough Device Designation application for its Saliva Glucose Biosensor for diabetes care...

South African Study Shows J&J’s COVID-19 Vaccine 85% Effective

by Samantha McGrail

Johnson & Johnson recently announced that its COVID-19 vaccine, Ad26.COV2.S, was 85 percent effective against coronavirus-related hospitalization in a Phase 3b study. The South African Medical...

FDA Grants Emergency Authorization to Roche’s At-Home COVID-19 Test

by Samantha McGrail

FDA recently granted emergency use authorization to Roche’s COVID-19 At-Home Test for children aged 14 years and older and by an adult for children aged two to 13 years. The COVID-19 At-Home...

Pfizer to Amend Clinical Study of COVID-19 Vaccine in Children

by Samantha McGrail

Pfizer and BioNTech recently announced that they will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their COVID-19 vaccine in children. The Phase 1/2/3 trial...

FDA Approves Pfizer’s Drug to Treat Adult Patients With AS

by Samantha McGrail

FDA recently approved Pfizer’s Xeljanz (tofacitinib) to treat adults with active ankylosing spondylitis (AS). The agency approved the drug specifically for individuals who have had an inadequate...

Moderna’s COVID-19 Vaccine Booster Protects Against Omicron

by Samantha McGrail

Moderna recently announced that its COVID-19 vaccine booster increased neutralizing activity levels against the Omicron variant. The currently authorized 50-microgram booster of mRNA-1273...

Kite’s Yescarta Helps High-Risk Large B-Cell Lymphoma Patients

by Samantha McGrail

Kite, a Gilead Company, recently announced positive primary results from a Phase 2 study of Yescarta in patients with high-risk large B-cell lymphoma (LBCL). The global ZUMA-12 study enrolled 42...

J&J’s CAR T-Cell Therapy Effective in Multiple Myeloma Patients

by Samantha McGrail

Johnson & Johnson recently announced longer-term results from the Phase 1b/2 study evaluating the safety and efficacy of its T-cell (CAR-T) therapy for patients with relapsed or refractory multiple...

Moderna Doses First Patients in Phase 2 Study of mRNA RSV Vaccine

by Samantha McGrail

Moderna recently dosed the first participant in the Phase 2/3 study of its mRNA respiratory syncytial virus (RSV) vaccine candidate. mRNA-1345 is an RSV vaccine for a prefusion F glycoprotein,...

Pfizer Confirms COVID-19 Vaccine Safety, Efficacy in Adolescents

by Samantha McGrail

Pfizer and BioNTech recently announced that their COVID-19 vaccine, BNT162b2, was 100 percent effective in adolescents 12 through 15 years of age in a longer-term analysis.  Researchers also...

US Gov’t Purchases 10M Courses of Pfizer’s COVID-19 Antiviral

by Samantha McGrail

The US government recently purchased 10 million courses of Pfizer’s COVID-19 antiviral candidate, PAXLOVID.  Under the terms of the agreement, the government will acquire 10 million...

Moderna’s mRNA Therapeutic Helps Patients With Heart Failure

by Samantha McGrail

Moderna recently announced that its mRNA therapeutic for heart failure patients undergoing coronary artery bypass grafting (CABG) surgery met its primary endpoint in a Phase 2 study.  The...

Opdivo Plus Chemotherapy Helps Non-Small Cell Lung Cancer Patients

by Samantha McGrail

Bristol Myers Squibb recently announced that Opdivo plus chemotherapy significantly improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer...