R&D/Clinical Trials

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.

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FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

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

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.

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.