PFIZER INC.

U.S. restarts free COVID test program, offering 4 free tests per household via COVIDTests.gov. Tests detect current variants and are usable through year-end. Over 900 million tests have been distributed. At-home tests provide results in 30 minutes or less, applicable to vaccinated and unvaccinated individuals. Vaccines, including mRNA and Novavax options, are also available, targeting dominant strains.

Tulisokibart, an anti-TL1A monoclonal antibody, outperformed placebo in inducing clinical remission at week 12 in moderate to severe ulcerative colitis, according to the ARTEMIS-UC trial. The study incorporated a predictive biomarker for response, showing significant clinical remission, endoscopic improvement, and clinical response in patients on tulisokibart compared to placebo. A phase 3 program is planned to confirm these results.

IBD, including Crohn's disease and ulcerative colitis, lacks reliable predictors for treatment response. This Research Topic aims to identify and validate novel biomarkers to optimize personalized therapy, focusing on genetic, microbial, transcriptomic, and immunologic data.

Pfizer withdraws Oxbryta from worldwide markets due to clinical data indicating the drug's risks no longer outweigh its benefits. The decision follows an imbalance in vaso-occlusive crises and fatal events observed in trials. Pfizer will halt clinical trials while reviewing data and advises patients to consult their physicians for alternative treatments.

Bispecific antibodies, designed to target two antigens simultaneously, are revolutionizing cancer treatment by enhancing antitumor immune responses and overcoming immune evasion mechanisms. The global market for these antibodies is projected to exceed USD 8 billion by 2023, driven by advancements in antibody engineering and increasing demand for targeted therapies. Major pharmaceutical companies are investing in bispecific antibody research, with strategic collaborations accelerating development. The market is expected to grow further due to expanding therapeutic applications and a shift towards personalized medicine.

Gene therapy Beqvez (fidanacogene elaparvovec) significantly reduces bleeding episodes in hemophilia B patients by 71% after a single infusion, with over half experiencing no bleeds, according to a clinical trial published in the New England Journal of Medicine. The therapy, approved by the FDA in April 2024, uses a virus to deliver a working factor IX gene to the liver, enabling continuous production of the clotting factor. Patients report a 'hemophilia-free state of mind' post-treatment.

Beqvez gene therapy significantly reduces bleeding episodes in hemophilia B patients, with 71% average drop and 50% bleed-free outcomes post-infusion, per NEJM study. FDA approved in April 2024, offering a single-dose alternative to regular factor IX infusions.

Gene therapy Beqvez significantly reduces bleeding episodes in hemophilia B patients by 71% post-infusion, with over half experiencing no bleeds. The therapy, approved in April 2024, delivers a working factor IX gene to the liver via a virus, potentially offering a single-dose, life-changing treatment.

Pfizer withdraws Oxbryta, a sickle cell disease treatment, due to safety concerns, halting clinical trials and global availability.

Pfizer withdraws Oxbryta, its sickle cell disease treatment, from global markets due to increased risks of vaso-occlusive crises and fatal events. The decision follows recent FDA approvals of two gene therapies for SCD, Casgevy and Lyfgenia, which offer potential cures but come with high costs.