R&D/Clinical Trials

Getting from insight to impact requires more than access to information.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

UCB enters agreement to acquire Candid Therapeutics in a deal worth up to $2.2 billion, adding BCMA-targeting T-cell engager cizutamig to expand its immunology pipeline.

FDA advisory panel backs Truqap combination in PTEN-deficient prostate cancer, signaling potential expansion into biomarker-defined mHSPC population with limited treatment options.

RNA rewards companies that can integrate biology, data science, manufacturing, and clinical development into a single adaptive engine.

Kaida Biopharma’s chair and acting CEO discusses how President Trump’s MFN policies and other regulatory actions are impacting pharma’s ability to invest in new treatments and adjusting international launch strategies.

Teva will acquire Emalex to add ecopipam, a late-stage pediatric Tourette syndrome candidate, ahead of a planned 2026 filing.

Eli Lilly to acquire Ajax Therapeutics in up to $2.3B deal, adding a first-in-class Type II JAK2 inhibitor to strengthen its blood cancer pipeline.

MaxCyte’s CEO explains the various ways CGT is impacted by new technologies and methods of treatment delivery.

Eli Lilly’s acquisition of Kelonia Therapeutics signals a potential shift in the cell therapy landscape, as in vivo approaches aim to overcome the cost, complexity, and access limitations of traditional CAR-T treatments.

Samsung Bioepis’ SVP and head of US commercial discusses the pricing, regulatory, and broader issues impacting the biosimilars market.

ARS Pharmaceutical’s CEO discusses how reformulating drugs and updating delivery design can improve the rate of patient adherence to medication.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses how the Tecvayli and Darzalex Faspro combination delivers deep, durable responses, along with its rapid FDA review.

Eli Lilly releases new safety data after FDA requested additional data to conduct extensive post-approval safety studies for Foundayo, including long-term monitoring of cardiovascular, liver, and thyroid cancer risks.

Biotech financing activity this week underscores strong investor backing for platform-driven innovation, with capital flowing into ADC development, precision immunology, multi-cancer diagnostics, and non-invasive oncology technologies aimed at addressing persistent gaps in care.

Identiv’s VP of healthcare discusses the impact of new technology and data collection on trial design.

Regeneron and Telix have entered a radiopharmaceutical collaboration worth up to $2.1 billion in milestones, combining antibody-based targeting with isotope delivery to develop next-generation precision oncology therapies.

Citeline’s VP of commercial, patient engagement, and recruitment discusses how clinical trial design must adapt to modern issues.

C4 Therapeutics and Roche expanded their partnership to develop next-generation degrader-antibody conjugates, a novel oncology approach designed to improve the precision and therapeutic index of traditional antibody-drug conjugates.

This disconnect between clinical efficacy and real-world utilization remains one of the most persistent challenges in lipid management.

Phenomix CEO Mark Bagnall discusses the effectiveness of GLP-1s and how obesity impacts different patients in a variety of complex ways.

Dismissing the role of independent, outside experts in FDA decision-making weakens the drug review process.

Imunon’s CEO discusses how FDA allowing the Bayesian method impacts innovation in the clinical trial space.

Pfizer and BioNTech halted a large U.S. clinical trial targeting healthy adults aged 50 to 64 after enrollment shortfalls made it impossible to generate the post-marketing data the FDA required.

Members of PacBio and iHope discuss collaboration and the global state of genomic testing.