Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
The 340B Drug Pricing Program faces scrutiny after a Florida fraud case and data showing hospitals earn billions in profits. Lawmakers propose new accountability measures, while hospital advocates defend its role in funding community care.
The Trump administration’s proposed 2027 insurance regulation omits copay accumulator protections, allowing insurers and PBMs to continue diverting billions in manufacturer copay assistance from patients. Advocates warn that without action, rising out-of-pocket costs will further strain patients. The rule also fails to close a loophole for large group plans regarding essential health benefits.
Systematic review confirms hepatitis B birth dose is safe and effective; separate study finds childhood vaccination linked to significantly lower HBV coinfection in people with HIV.
Researchers have discovered a novel broadly neutralizing antibody, 007, that targets the HIV-1 V3 glycan site in a glycan-independent manner, overcoming escape mechanisms. The antibody demonstrated robust neutralization of resistant viral strains, synergized with existing antibodies in humanized mice, and is now advancing preclinically with Vir Biotechnology. This breakthrough may guide next-generation vaccine strategies amid ongoing efforts to induce broadly neutralizing antibodies through novel immunogen designs.
Studies reveal age-related infectious disease patterns including higher symptomatic rhinovirus risk in adults over 60, polypharmacy complications in infectious disease patients, and significant underutilization of COVID-19 antivirals among older adults despite proven benefits.
University of Alberta researchers have identified the protease GlpG as a new drug target for antibiotic-resistant E. coli, which causes hundreds of thousands of UTI deaths annually. Inhibiting GlpG prevented bacterial adhesion and biofilm formation in laboratory studies. The discovery addresses a global health emergency as antimicrobial resistance projections show it could cause cancer-level deaths by 2050.
PancreaSure detected advanced PDAC with 87.9% sensitivity and 97.7% specificity, outperforming CA19-9 alone. PanMETAI, an AI metabolomics model, achieved AUC 0.99 in training and 0.93 in external validation for early PDAC detection.
The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07807137 |
City-Wide Implementation and Evaluation of the B-OK Bottles for HIV Treatment Adherence Support in the Philadelphia Ryan White Medical Case Management Network |
NOT_YET_RECRUITING | |
| NCT07804602 |
PositiveLinks for Youth (PL4Y) for Texas |
NOT_YET_RECRUITING | NA |
| NCT07804121 |
Project SHIELD 2.0: Police Education to Support Public Health in Kentucky |
RECRUITING | NA |
| NCT07793006 |
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease |
RECRUITING | NA |
| NCT07792070 |
Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings |
COMPLETED | NA |
| NCT07785388 |
Genistein for the Reduction of Adverse Cardiovascular Events (GRACE) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07769580 |
Project SPACE: Testing Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior |
NOT_YET_RECRUITING | NA |
| NCT07762612 |
"Gwan Enjoy Life:" A Peer-Supported Mental Health Mentoring Intervention to Improve Engagement in Care Among Sexual Minority Men Living With HIV in Jamaica |
NOT_YET_RECRUITING | NA |
| NCT07762066 |
Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men |
RECRUITING | NA |
| NCT07757802 |
Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults |
NOT_YET_RECRUITING | PHASE1 |
