R&D/Clinical Trials

BeOne Medicines’ John Oyler on building an oncology pharma power from a disruptive idea — and playing the long game on speed, science and scale.

FDA places full clinical hold on Aardvark’s ARD-101 in Prader-Willi syndrome after heart-related adverse events, pausing late-stage studies and raising new questions around safety in appetite-regulation therapies

Trialynx’s CEO discusses the benefits of using AI for trial design and how to find the AI companies doing the most promising work.

Why future oncology leaders will be defined by ecosystem orchestration.

Eli Lilly reported late-stage data showing patients with obesity were able to maintain long-term weight loss after transitioning from higher-dose injectable incretin therapies to lower-dose Zepbound or the company’s oral GLP-1 candidate Foundayo.

Bristol Myers Squibb and Hengrui Pharma launch a multibillion-dollar collaboration spanning 13 oncology, hematology, and immunology programs to expand global drug development pipelines and accelerate early-stage clinical innovation.

FDA extended its review of Leqembi’s once-weekly subcutaneous starting dose for early Alzheimer’s disease by three months after requesting additional information from Eisai and Biogen.

Radiopharmaceutical logistics is fundamentally different from traditional pharmaceutical supply chains.

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting interest in nonsteroidal topical therapies for long-term disease control.

In today's Pharmaceutical Executive Daily, Bayer agrees to acquire Perfuse Therapeutics for up to $2.45 billion and Madrigal obtains an exclusive global license for a precision siRNA therapy targeting a key genetic driver of MASH, Zentalis Pharmaceuticals announces the first patient dosed in a Phase III trial and Brooke Ervin argues that translating real-world evidence into commercial and clinical impact in urology requires more than access to data.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

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.