Product Development

Success in lung cancer niches will hinge on access to next-gen sequencing

New targeted lung cancer therapies against RET, KRAS and c-MET are all outperforming standard of care in the clinic, including checkpoint inhibitors. But whether these therapies see uptake will likely depend more on whether next-generation...

Pharmas’ challenge: learning from rare disease units while leaving them alone

How do you build a rare disease portfolio inside a pharma focused on large indications, and do right by both the new and the old? That’s a question faced by pharmas expanding from their traditional...

Regeneron’s evinacumab data could make it the therapy of choice in HoFH

With a cleaner safety profile and better efficacy than marketed agents, Regeneron’s first-in-class evinacumab is poised to become the standard of care for homozygous familial hypercholesterolemia and other rare lipid disorders, including for the hardest...

Growing China’s capacity to conduct high-quality trials

As more companies conduct clinical trials in China, they are facing increasingly steep competition for patients and PIs at the country’s small number of established clinical trial centers. To break the logjam and tap a...

Back to School 2019: Rules of the road for digital health

There is a moment, just as a new technological wave starts to swell, when those creating the platform and those who will be affected by it can come together to shape its future. This moment...

Privacy, transparency and consent

Patients need to control the use of their data. This calls for new policies on transparency and consent, and means establishing systems governing the ownership, collection and agency of those data. Data privacy is probably...

Criteria of demarcation

Clear lines must distinguish what will and won’t be regulated in digital health. This involves new concepts of product identity and quality, entrenching the idea of continual change. In digital health, many of the best...

Rethinking first principles

Stakeholders will need to draft a new set of first principles to inform the rules of the road for digital health, because many of the traditional elements of clinical development may not have meaning. Drug...

Digital tech meets the patient: first movers are bringing digital to biopharma

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...

Digital health: payers are figuring out what it’s worth

Payers are starting to sort out how to reimburse for digital therapies and tools while they get up to speed on the new class of products. The answer is more of an “it depends” than...

Pharmas in the digital game

Almost all pharmas have at least tiptoed into digital health, while some have taken a full plunge. Among 25 pharmas and big biotechs surveyed by BioCentury, nearly all have engaged in digital health deals, and...

Digital dollars: financing for digital health

The heyday of digital health may not yet even be on the horizon, but investments in the field are certainly starting to hit the radar in the areas most likely to impact patients first --...

China’s biosimilars in fast lane

Though coming from behind, China is cracking the seal on its biosimilar market and may even be poised to over-take the U.S. and Europe in less than a decade. On February 22, 2019, China’s National...

ACRES’ plan to harmonize clinical trials across many lands

With the launch of its clinical site accreditation program, ACRES has taken the first step toward its larger goal of creating a clinical research infrastructure that is digitally connected and operates under a single set...

Payers’ view of reimbursement when gene therapy isn’t enough

Spinal muscular atrophy is giving payers a new conundrum, and the indication is poised to become a testing ground with implications for many if not all gene therapies. The issue is whether, and how, payers...