Titan Pharmaceuticals Inc. is a step closer to filing a new drug application (NDA) for its Probuphine as a weapon to fight opioid dependence.

WASHINGTON – Amid criticism that the FDA has yet to strike the right balance between risk and benefit, the agency's Janet Woodcock gave a House subcommittee a sneak peak of proposed PDUFA V enhancements that would address those concerns.

Like many biotechs these days, Idera Pharmaceuticals Inc. is feeling the pinch as a big pharma partner shifts its pipeline priorities, leaving the future of Idera's lead TLR9 compound up in the air.

Archimedes Pharma Ltd.'s Lazanda isn't the first fentanyl product to get the FDA's nod for breakthrough cancer pain, but its pain-free risk evaluation and mitigation strategy (REMS) and intranasal delivery could give it an edge in the U.S. market once it launches in the fall.

Comparative-effectiveness research (CER) is a C-suite issue that is already reshaping how some biotechs do business.

When it comes to the virtual world, a number of biotechs are downright antisocial.

WASHINGTON – Recognizing that regulatory science isn't keeping up with innovation in the U.S., the Biotechnology Industry Organization (BIO) donned its thinking cap to come up with some practical solutions.

WASHINGTON – Even before overcoming the safety, efficacy and approval hurdles, biotechs should be looking ahead to the fourth hurdle – reimbursement.