Insights

The now-urgent automation agenda: out-of-control regulatory workloads necessitate AI adoption

A new independent survey of senior US pharma regulatory professionals suggests that commitment to AI investment is much higher than might be expected, although...

Improving life science R&D outcomes with AI

Maximizing the potential AI/data-driven model of drug discovery requires the technology’s full integration into R&D. Biorelate’s Dr Ben Sidders explains. Pharma R&D latest disruption is...

The medical device sector’s surging regulatory burden: how are suppliers coping?

Regulators around the world are increasing their scrutiny of medical devices as these become more critical to patient outcomes. Referencing new research, Peter Muller...

The Future of Gene Therapies: Three Trends

“Maps don’t show you where you will go in life, they show you where you might go.”—John Green Over...

A Patient Centric Approach to Clinical Research is Key for Product Development

Ensuring a patient centric approach during clinical research is vitally important to research sponsors and their partners. A clinical research site that...

The FDA and AAV-Based Gene Therapy Safety: What You Should Know

Science fiction author Arthur C. Clarke once commented that “Any sufficiently advanced technology is indistinguishable from magic.” Over the last couple of...

Patient Engagement – What History Teaches Us About Pharma’s Future Evolution

The pharmaceutical industry continues to grow by leaps and bounds. Advancements are happening on a weekly basis. But every time we take...

Monoclonal Antibodies Offer Much Needed Protection for the Immunocompromised Population

Even though we don’t feel it or notice it, each minute, our bodies’ immune systems are hard at work eliminating abnormal cells,...

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Ro Partners With Eli Lilly to Offer Zepbound, a Weight-Loss Medication, in Single-Dose Vials

Ro, a direct-to-consumer health and wellness company, has announced a partnership with Eli Lilly to provide discounted single-dose vials...

FDA Identifies Further Safety Concerns With Intercept’s Liver Drug

The Food and Drug Administration (FDA) has uncovered additional safety concerns related to a medication used to treat a...

Corcept’s ALS Modulator Fails to Meet Primary Endpoint in Phase 2 Study

After Amylyx and PTC, Corcept has also decided to withdraw from the amyotrophic lateral sclerosis (ALS) space. Results from...

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Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

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Novo Nordisk resubmits Ozempic for FDA review with new dosing regimen

Novo Nordisk is launching a new dosage regimen for Ozempic for the second phase. After a rejection by FDA in March

BMS Terminates Two Mid-Stage and Four Early-Stage Clinical Initiatives

During an R&D Day presentation, Bristol Myers...