R&D/Clinical Trials

FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.

Ipsen is withdrawing its EZH2 inhibitor Tazverik from all markets after an ongoing clinical trial identified safety concerns involving secondary blood cancers.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes shifting regulatory signals for Moderna’s mRNA flu vaccine review and raises broader questions about the stability of the approval pathway.

FDA informed uniQure it will not accept external control data as the primary basis for approving AMT-130, instead demanding a prospective, randomized, sham surgery-controlled trial before moving forward.

In this Pharmaceutical Executive Academy discussion, Najat Khan, PhD, CEO of Recursion Pharmaceuticals and former chief data science officer at J&J, explores the intersection of AI, pharma, and patient care — and the strategic pivots necessary to drive measurable and lasting gains across the value chain.

RWD can bolster natural history studies with insight to longitudinal, real-time disease progression.

Otsuka America’s president and CEO discusses being the first major pharma company to invest in psychedelics.

Novo Nordisk partners with Vivtex Corporation to develop next-generation oral biologics for obesity and diabetes, while GSK agrees to acquire 35Pharma Inc. to expand its pulmonary hypertension pipeline.

Immuto’s CEO discusses the benefits of SPCs for target discovery.

The COVID-19 pandemic dramatically accelerated cancer-vaccine science by validating the mRNA technology at global scale.

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.

Kim Boericke, CEO, Veristat, discusses how Veristat is adapting clinical trials by using data, AI, and operational planning to optimize site selection, manage complex cell and gene therapy logistics, and streamline analytics.

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.

Kim Boericke, CEO, Veristat, touches on how early strategic consulting, data analytics, and automation help optimize trial design, define realistic patient populations, and generate faster insights.

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.