A drastic risk-off pullback in the public market can close an IPO window while private biotechs aspiring for either a public debut or an acquisition by big pharma may be stymied by their stale valuations.

Companies with large-molecule expertise increasingly are eyeing primary care markets, confident that improvements in safety and efficacy will make them competitive with oral standards of care.

FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.

An agile and energetic cohort of biotech platform companies plans to capture Big Pharma's imagination--and its pocketbook--by going after intractable drug targets that have long eluded the industry, and they're doing it on a shoestring budget.