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,...

Latest news

FDA Approves Romvimza for Treatment of Tenosynovial Giant Cell Tumor

The U.S. Food and Drug Administration (FDA) has approved Romvimza (vimseltinib) for the treatment of tenosynovial giant cell tumor...

FDA Approves Penmenvy Vaccine for Meningococcal Disease Prevention

The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W,...

Former Inizio Evoke Executives Launch Flex Marketing

A group of former executives from health communications firm Inizio Evoke have launched Flex Marketing, a new independent agency...

Must read

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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Pfizer’s hemophilia gene therapy approved by the FDA

The Food and Drug Administration (FDA) has just greenlighted...

Karuna Therapeutics Phase 1b Trial Results Reinforce Cardiovascular Safety of Schizophrenia Treatment KarXT

The  Phase 1b unrestricted-label, eight-week residential trial...