R&D/Clinical Trials

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.

Limited patient populations require sponsors to adapt their practices when working in the rare disease space.

Jiang Li, CEO of Vivalink, continues his conversation with Pharmaceutical Executive, this time discussing the impact of continuous monitoring on patient adherence.

RDEP is a sign that regulators acknowledge that rare disease is a unique space that requires special attention.

Vivalink’s CEO Jiang Li, PhD, discusses the importance of including as much information with clinical data as possible.

Inside Consano Bio’s bet on first-in-class nerve repair—and what it takes to lead an early-stage biotech through uncertainty.

FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.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