With input from two long-time observers of the biopharma industry and its U.S. regulator, this article covers a cross-section of opinions regarding trends and proposals for improving the FDA review process.

What can make a company decide to enter new therapeutic entities into clinical development after decades as a dedicated supplier to bio research labs? Here we explain the reasons and implications of ArunA Bio’s decision.

Pluristem offers one example of how a new company in drug development can build the needed infrastructure to maintain its independence as a sponsor.

Obsidian Therapeutics targets gene and cell therapies with a technology designed to control the production and activity of therapeutic proteins those therapies induce.

This month’s company to watch is eXIthera, which is focused on inhibiting Factor XIa, a new target that may offer a way to avoid the bleeding problems with current anticoagulants.

Leading Biosciences is applying the science of digestive proteases to treating or preventing multiple diseases and conditions, starting with delayed return of post-surgical bowel function (ileus) and adhesion with its lead product candidate, coded LB1148.

One company is atypical in the industry for its use of patient and caregiver input to guide its drug-development journey. That shows in the program for its lead drug entering later-stage trials in treating Alzheimer’s disease.

The story of the business challenges faced by Diasome Pharmaceuticals as it develops its insulin-enhancing delivery technology, which seeks to correct a long-known deficiency in subcutaneous injection of insulin.

Bioharmony Therapeutics is developing novel, “lysin-based” antimicrobials. The company is out to change the world of antibiotics, not by tweaking an old formula, but by advancing an entirely new mode of action.

Angion is developing a small molecule mimetic of the hepatocyte growth factor (HGF), which works to protect kidney and other organ cells from damage due to disease, physical injury, and indirect consequences of surgery and trauma.

Synlogic is an early-stage developer of “synthetic biotic” medicines — therapeutics consisting of beneficial microbes genetically engineered to treat rare metabolic diseases.

An exclusive interview with Rachel King, a business person dedicated to a science-driven sector, who is CEO of GlycoMimetics, an oncology-focused biotechnology company.

This 15-person virtual biotech is trying to stop immune-mediated disease early, before it becomes a chronic condition.

Medicines360 is using all its developed-world revenue to extend access to essential medicines to all women, regardless of the economic and healthcare circumstances in their part of the world.