R&D/Clinical Trials

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.

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FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.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