I'm always excited for new data on new treatments and old treatments. Anytime we get really excited about a new potential molecule that we see phase 1 and phase 2 data for, we need that big phase 3 ...

Background Difference-in-differences is a method commonly used in population health research. It is based on assumptions that ...

Scientists have long known that the DNA code in genes is not the only way to pass genetic traits from parents to offspring. "Epigenetic" marks—chemical modifications to DNA that don't change the DNA ...

Resources for observational comparative research have expanded enormously in recent years to include very large sources of granular, routinely collected health care data and modern statistical, ...

Case studies serve as an excellent resource for devising innovative sales strategies, and providing insights into successful maneuvers and problem-solving techniques. Innovation Inspired by Proven ...

The European Medicines Agency (EMA) has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative ...

Once again, the Supreme Court torpedoed my plan to write about its tariff decision by not making one, and it now appears that the column will have to wait until February. Meanwhile, tariff payments ...

This paper presents the findings of the Siemens Healthineers SHIFT Innovation Pan-Africa Capacity Building Program, which aims to improve access and affordability of healthcare across Africa through ...

Abstract: Vision systems are nowadays based on smart cameras that are integrated into Industrial Control System (ICS) using Industrial Internet of Things (IIoT) principles. The information between ...

The FDA is revising biosimilar approval processes, eliminating "switching" and comparative efficacy studies, favoring analytical assessments. These changes could reduce development costs by 80%, ...

Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...