Curated news and analysis on clinical trials, drug approvals, and medical research.
Industry experts emphasize that empowering clinical sites with patient-first strategies and treating patient experience as a strategic investment can dramatically improve recruitment and retention in human-centered trials. Flexible trial models, community outreach, and early engagement with advocacy groups are cited as key approaches to reducing patient burden and avoidable dropouts.
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
Compugen reported a Q1 2026 net loss of $7.7 million with approximately $134.9 million in cash, expecting runway into 2029. The COM701 MAIA-ovarian trial is enrolling across the U.S., Israel, and France, with interim analysis expected by Q1 2027. Partner AstraZeneca is advancing rilvegostomig across 11 Phase 3 trials.
Rural cancer death rates are highest while big-city rates are lowest, a study of 28 million deaths found. However, separate research shows rural lung and colon cancer patients treated locally had similar outcomes to those at urban centers.
Two JAMA Network Open studies highlight persistent racial disparities in cancer. One found early-onset cancer rates declining in men but rising in women, with significant variation by race across cancer types. A separate analysis of ovarian cancer trials showed Black patients had lower overall survival and were underrepresented in clinical research.
Recent studies using FDA Adverse Event Reporting System data have identified drug-associated cardiovascular risks, pediatric dry eye, and venlafaxine adverse effects. Findings highlight the importance of pharmacovigilance monitoring.
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
The treatment landscape for multiple myeloma is evolving rapidly with T-cell engaging therapies like bispecific antibodies and CAR T-cell treatments shifting care toward a chronic condition with potential treatment breaks. This evolution is creating new side effect management challenges and complicating clinical trial design as sponsors grapple with selecting comparator arms and adapting to a rapidly shifting standard of care.
New synthetic methods provide access to congested cyclobutanes, bicyclo[2.1.1]hexanes, and housanes for use as 3D scaffolds or bioisosteres in drug discovery. The approaches enable improved solubility and metabolic stability in drug analogues while maintaining biological activity.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
The FDA has approved Shionogi's XOCOVA (ensitrelvir) as the first oral antiviral for post-exposure prophylaxis of COVID-19. Approval was based on the Phase 3 SCORPIO-PEP trial, which showed a 67% reduction in risk of symptomatic disease after exposure.
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
CARsgen Therapeutics has signed a RMB370 million agreement to build a CAR T-cell manufacturing base in Shanghai, supporting commercialization of its marketed and late-stage products. Meanwhile, investment firm HarbourVest disclosed a $21 million position in CAR-T developer Generate Biomedicines, which holds $516.6 million in cash after its IPO.
An experimental pill called daraxonrasib nearly doubled survival for patients with advanced pancreatic cancer in a clinical trial, marking a significant advance for a deadly disease. The drug targets a mutated protein previously considered "undruggable" and reduced the risk of death by 60% compared to chemotherapy.
Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
The NHS-Galleri trial of the Galleri multi-cancer early detection test did not meet its primary endpoint of reducing combined Stage III-IV cancers. Secondary results showed a 26% reduction in Stage IV diagnoses by the third screening round for 12 deadly cancers. The test increased cancer detection rates four-fold compared to standard screening alone.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
Recent studies and expert discussions highlight using ctDNA testing to guide surgery decisions for older ER-positive breast cancer patients and integrating FAST-Forward and PRIME II trial data to personalize radiation therapy and sequence with ADCs like T-DXd.
