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Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.

Reed O’Connor’s ruling is a setback for smaller MA plans — and efforts to curb predatory marketing to seniors.

The startup intends to make a small patch pump with a closed-loop algorithm for nighttime glucose control.

Overall customer satisfaction with MA plans fell 29 points year over year, driven by a declining level of member trust in their health plans, according to J.D. Power.

In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.

The Texas judge’s decision — which picked apart Elevance’s argument on mathematical grounds — could cost Elevance $375 million, though the insurer could still appeal.

The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.

Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.

With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.