Product Development

UCB adding Ra’s rare immunology assets in $2.5B takeout

UCB is looking to build its rare disease immunology franchise through its proposed $2.5 billion acquisition of Ra Pharmaceuticals -- a price that more than doubles the biotech’s valuation. The deal would give UCB S.A....

Lessons from Healey ALS on how to build platform trials quickly

The first ever platform trial in ALS provides a recipe for getting these collaborative studies off the ground quickly and with early buy-in from companies. Platform trials take advantage of a master protocol to test...

Reading into the first wave of neoantigen results

The first clinical data from neoantigen vaccine companies have started to answer questions about the best way to quickly gauge whether patients are responding. The lessons include how to design combination trials that point to...

First adaptive platform trial in ALS could speed development, find new biomarkers

An adaptive platform trial for ALS launched by Mass General could find new biomarkers to serve as surrogate endpoints or predictors of response in the pivotal trial and future studies. Researchers at Massachusetts General Hospital’s...

Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

The mounds of post-market safety data now being generated through social media and other non-traditional data sources are overwhelming regulators and often hindering pharmacovigilance, not improving it. Industry groups have proposed updates to ICH guidelines...

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...