News and Blog

Researchers and physicians have historically taken a compartmentalized approach to medicine: neurologists treat conditions of the brain, gastroenterologists address concerns of the digestive system, and psychiatrists administer care for mental health. Seldom have these specialties intersected in meaningful ways.

Most leaders tune out when they hear “tax credit.” That may be a mistake. R&D credits have quietly expanded and can unlock real strategic value for life sciences companies. I’ve spent enough time in boardrooms and leadership meetings to know that when someone says “tax credit,” most ears glaze over. It’s the kind of topic that lands squarely in the important but not urgent bucket. And yet, the conversations I’ve been having lately with experts in the life sciences are making me rethink that instinct.

Scientists have studied Alzheimer’s disease for over a century, since Alois Alzheimer’s initial description of brain abnormalities in a patient with presenile dementia. Today, amyloid‑beta plaques and tau tangles are recognized as hallmarks of the disease, though its causes are complex and multifactorial.

In 2023, Berkley Life Sciences published a blog post titled PFAS “Forever Chemicals” in Medical and Life Sciences Products – Who Should Be Worried?. At that time, most per- and polyfluoroalkyl substances (PFAS) litigation to date focused on lawsuits against PFAS manufacturers, alleging personal injury from PFAS exposure. Since then, PFAS litigation has evolved, and both the U.S. Food and Drug Administration (FDA) and European Chemicals Agency (ECHA) have issued updates, warranting a fresh look at this topic.

Montana's Right to Try laws - Senate Bill 422 (2023) and Senate Bill 535 (2025) allow any patient, not just those with terminal illness, to access experimental treatments that have passed Phase 1 safety trials. Clinics offering these treatments must be licensed and contribute to patient support funds. Patients must provide informed consent before treatment.

Traditional pediatric prosthetics present significant challenges for families and clinicians alike. These devices are often expensive, difficult to customize, and inaccessible to children in remote or low-income areas. Because children grow quickly, prosthetics require frequent replacements and adjustments, adding financial and logistical strain.

A transformative shift is underway in the life sciences sector, particularly regarding digital health products. Increasingly, life science companies are moving beyond developing medical technology solely for healthcare providers. Their focus now includes developing, marketing, and selling digital products directly to patients as consumers. Diagnostic tools such as self-administered glucose monitors, wearable electrocardiograms, and other self-administered tests, monitors, and therapies are increasingly common.

At my last doctor’s appointment, I learned how to use my smartwatch to perform an electrocardiogram (ECG) to test for atrial fibrillation. Naturally, I found myself checking my ECG multiple times a day, curious about the fluctuations in my heart rate. Did I have cause for concern? Fortunately, my watch consistently reported no evidence of atrial fibrillation, while also issuing a clear disclaimer that it could not detect signs of a heart attack.

The term “digital twin” may evoke images straight from the pages of science fiction, such as Nobel Prize winner Kazuo Ishiguro’s dystopian novel, Never Let Me Go, in which biological clones are raised solely for their organs. In reality, the concept of a digital twin in medicine—while still emerging—is no longer confined to fiction.

Last year, Berkley Life Sciences’ Blog featured an important post on Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain. That article highlighted potential supply chain constraints caused in-part by sterilization facility shutdowns and regulatory requirements to install or upgrade emission control equipment. What that post did not address—and what this article will explore—is the nationwide litigation that has impacted the sterile medical device industry over the past five years.