Author name: Leonardo Arias

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.

The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air.

The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges, not least of which is the budgetary and operational strain that come with clinical development across many indications.

Employers surveyed by the Business Group on Health are bracing for the largest annual increase in healthcare costs in more than a decade — a sobering prospect, one expert said.

O’Hara joins CMR’s executive team as commercial president and general manager for the U.S., following the FDA’s authorization last fall for its Versius system.

Don Trigg, an alum of primary care and navigation firm Apree Health and EHR vendor Cerner, will take up the role on Sept. 2.

The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”

The skilled nursing operator filed for bankruptcy in July, a “predictable” outcome after years of financial mismanagement from Genesis’ private equity investors, according to the Private Equity Stakeholder Project.

CEO Geoff Martha told investors that the initiatives were done in partnership with the activist investor firm Elliott Investment Management.

The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid anyway.