CLEVELAND – A technology so promising it took the FDA barely 100 days to clear it for marketing approval topped the Cleveland Clinic's list of 10 innovations expected to have significant impacts on health care in 2018. Unveiled on the last day of the 15th annual Medical Innovation Summit, the list leads with the closed-loop insulin delivery system for type 1 diabetes and includes advances such as gene therapy and telehealth that have been years in the making.

CLEVELAND – Cleveland Clinic CEO Toby Cosgrove called genomics and precision medicine the "fastest-moving elements of today's medical universe. Barely on the radar 15 years ago, today they fill the screen." As this year's focus at the Medical Innovations Summit, genomics and precision medicine are considered the future in health care, but, as many panelists noted, as the technology side of the equation continues advancing toward the end goal, clinicians and regulators will need to keep up.

CLEVELAND – If the health care industry were a baseball game, it would currently be in the third inning, said Cleveland Clinic President and CEO Delos "Toby" Cosgrove, who told attendees of the 15th Medical Innovation Summit kicked off Monday he is "always stunned by the data [and by] how fast knowledge is accumulating."

Prospects for Durect Corp.’s Posimir (Saber-bupivacaine) dimmed dramatically with the late Thursday disclosure of a failed phase III study of the extended-release analgesic. Data from the PERSIST study, which had been designed to address a 2014 FDA complete response letter (CRL), showed a favorable trend but fell short of statistical significance on the primary endpoint of reducing pain on movement over the first 48 hours after surgery.

Curevac AG's efforts in upgrading its mRNA vaccine platform over the past decade helped lead to its largest collaboration to date, a pact with Eli Lilly and Co. that comes with a $50 million up-front payment, an equity investment of €45 million (US$53 million) and up to $1.7 billion in potential milestones if all five cancer vaccine candidates are developed, plus tiered royalties on any products that make it to market.

Warp Drive Bio LLC's back-to-nature drug discovery approach landed another deal, this time a potential $387 million pact with Roche Holding AG to discover new classes of antibiotics for drug-resistant gram-negative pathogens. Warp Drive CEO Laurence Reid called it a "huge opportunity to make a contribution to a global problem."

Biocon Ltd. said Tuesday the FDA issued a complete response letter (CRL) for partner Mylan NV's BLA for MYL-1401H, a proposed biosimilar of Amgen Inc.'s Neulasta (pegfilgrastim), the latest biosimilar version of the long-acting G-CSF drug to hit a regulatory snag.

In a move that caught many by surprise, the FDA late Tuesday approved Mylan NV’s generic version of Copaxone (glatiramer acetate injection), both the 40-mg and 20-mg formulations, sending shares of Mylan (NASDAQ:MYL) up 16 percent. The Hertfordshire, U.K.-based firm said it planned to begin shipping its AP-rated – i.e. substitutable – versions of the relapsing multiple sclerosis drug “imminently.”