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The regulatory uncertainty around biosimilars in the United States is finally lifting, just months after the first biosimilar monoclonal antibody hit the US market.
Despite the failure of Eli Lilly's anti-amyloid antibody solanezumab in its latest phase III trial for Alzheimer disease, a bulging pipeline of amyloid-modulating candidates and novel clinical trial strategies still hold promise.
Pivotal trials of Alkermes's antidepressant ALKS 5461 show how a patented clinical trial design might be able to help control problematic placebo responses.
Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint inhibitors, oncolytic viruses and modified T cell therapies.
Clinical trial failures of two drugs for hearing loss and tinnitus underscore pitfalls for a nascent area of drug development, but lessons learned may help in navigating the uncharted path to approval.
Although Agios and Celgene are set to file for approval for their first-in-class cancer metabolism drug, the field has started looking in new directions for the next batch of metabolic targets.
A wave of companies are developing personalized vaccines, built from tumour-specific neo-antigens, providing a timely boost for a failure-ridden area of cancer immunotherapy.
AbbVie, Bristol-Myers Squibb, Genentech, Janssen and Merck & Co. have all advanced anti-tau candidates into Phase I trials in the hunt for drugs that can modify the course of Alzheimer disease.
Less than 6 months after Zika infection was declared a public health emergency, the first clinical trials of DNA vaccines against the virus are beginning.
The leading candidate for the repair of the central nervous system in multiple sclerosis failed in a Phase II study, highlighting the complexity ahead for a burgeoning pipeline of academic-led projects.
The search for better immunotherapy biomarkers is forcing the field to reconsider how it classifies cancers, with implications for the next wave of combination studies.
Drugs that tap into macrophages' natural appetites, find ways to reduce their immunosuppressive effects or reduce their presence in the tumour milieu could complement existing immuno-oncology strategies.
Industry's overenthusiastic embrace of massive Phase I oncology trials is forcing oncologists and regulators to define the appropriate use of seamless clinical trials.
