R&D/Clinical Trials

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.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, notes select influences of how the Phase III clinical testing was conducted.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, touched on Tecvayli plus Darzalex Faspro reducing the risk of disease progression or death by 83%, and what that signals for patients.

Thomas Newcomer of Samsung Bioepis discusses how certain classes of drugs don’t have enough biosimilars in development and the impact that this can have in the coming years.

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.

Soley Therapeutics’ CEO and co-founder discusses the importance of understanding why some cells survive under stress and others don’t.

Merck is partnering with Infinimmune in a deal worth up to $838 million to leverage AI-driven antibody discovery.

Yerem Yeghiazarians, MD, explains how understanding how various cells react differently to stress impacts how damaged cells may potentially be treated.

Yerem Yeghiazarians, MD, discusses the importance of understanding why certain cells (like cancer cells) can survive in situations that would kill other healthy cells.

While the space has traditionally been dominated by smaller biotechs, that may be changing.

Merck agrees to multi-year research collaboration with Quotient Therapeutics in a deal worth up to $2.2 billion to use somatic genomics and AI-driven analytics to identify new drug targets for inflammatory bowel disease.

FDA has provided opportunities for R&D in rare disease, although recent developments have caused significant setbacks to occur.

Novartis agreed to acquire SNV4818 in a deal worth up to $3 billion, while Collegium Pharmaceutical is set to acquire Azstarys for up to $785 million.