R&D/Clinical Trials

Study results showed that patients saw three years of remission while taking the medication.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

Greater Miami is rapidly emerging as an international biotech hot spot—as capital, talent, and infrastructure converge to transform the region from a tourism-driven economy into a globally connected life sciences innovation hub.

CSL Limited has licensed global development and commercialization rights for clazakizumab to Eli Lilly and Company outside of ESKD-related cardiovascular risk.

Without new legislation, pilot programs, or years of rulemaking, the agency could use enforcement discretion to create a fast, risk-based pathway for low-risk early-stage trials.

Phesi’s founder and CEO discusses recent trends in clinical trials.

Special Guest Op-Ed: What a decade of collaboration and shared effort reveals about the future of drug development.

Pharm Exec’s 21st Annual Pipeline Report examines emerging drug development classes, treatment modalities, and expansion pursuits in five therapeutic settings ripe for next-gen innovation.

THX Pharma’s licensing deal with Biocodex pairs late-stage rare disease assets with commercial infrastructure and non-dilutive funding, highlighting how biotech companies are sharing risk and leveraging partnerships to advance ultra-rare pediatric programs toward market.

The shifting landscape amid China's biotech rises presents both opportunities and geopolitical challenges for growth strategies.

Ken Banta and Andrew Hall share insights on leading through uncertainty—covering culture, capital, risk, and the regulatory headwinds influencing key decisions in drug development.

As innovative clinical trial designs gain traction, Billy Amzal, Head of Strategic Consulting at Phastar, discusses how to use real-world data effectively, shares practical examples and looks to the future of patient simulators and synthetic patients.

The collaboration highlights how pharmaceutical companies are pairing capital and global infrastructure with platform technologies that deliver differentiated dosing and durability.

The deal underscores a broader shift in autoimmune drug development toward therapies that aim to reprogram disease-driving immune responses at their source.

How demand-driven development will help new products be more successful.

The research collaboration will leverage Seamless’ recombinase technology to develop programmable treatments for hearing loss.

The collaboration with Qilu extends Insilico’s application of generative AI into cardiometabolic disease drug discovery, with both companies aiming to advance candidates from early design through development under a shared strategic framework.

Ethan Smith, therapy area director Oncology, Norstella, explores how antibody–drug conjugates are reshaping oncology, highlighting emerging challenges around treatment sequencing, safety management through real-world evidence, and differentiation as ADC pipelines become increasingly crowded.

Roche reported positive Phase II topline data showing that its once-weekly dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonist CT-388 achieved substantial, sustained, and dose-dependent weight loss through 48 weeks

The AI dilemma facing biopharma—and what’s at risk.

Clarivate’s Drugs to Watch 2026 report highlights Eli Lilly’s late-stage cardiometabolic candidates orforglipron and retatrutide as the clear standouts in an obesity and diabetes market projected to reach $150 billion by 2035.

Nimbus Therapeutics and Eli Lilly expand partnership with a new multi-year research and licensing collaboration aimed at advancing next-generation oral therapies for obesity and metabolic disease.

Sanofi and Earendil Labs' new collaboration pairs large-scale development capabilities with AI-driven protein discovery to accelerate next-generation bispecific therapies.

Hoth Therapeutics has filed dual provisional patents positioning HT-001 as a potential first-in-class solution for managing treatment-induced skin toxicities across modern oncology therapies.

AI’s transformative potential in clinical development relies on the industry's ability to rebuild its fractured data infrastructure.