Business Intelligence

Providers utilize business intelligence to monitor referral patterns and collaborate with clinicians who order their services. Such analytics tools have also been deployed in the specialty to improve productivity, track patient satisfaction and bolster quality.

FDA merges all adverse event reporting systems into new AEMS platform
Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.
Medical device manufacturer hit by cyberattack, possibly from Iranian-backed hackers
Stryker, a Michigan-based company that manufactures surgical implants, confirmed it was experiencing a global network outage. Employee devices reportedly displayed the logo of a pro-Iran cybercrime cell.
Medicare Advantage fraud allegations against Aetna settled for nearly $118M
The U.S. Department of Justice said the insurer upcoded patient diagnoses to boost risk-adjusted payments it received from the Centers for Medicare & Medicaid Services. The company did not admit to wrongdoing, despite agreeing to the payout.
FTC seeks more time to settle insulin pricing lawsuit with remaining PBM defendants
The request to the court comes a month after the agency settled with Express Scripts, under the condition the company change its wholesale buying practices, pass on manufacturer rebates and support TrumpRx.gov. Now it's up to CVS Caremark and UnitedHealth’s Optum Rx to make deals of their own.
Blood filtration company fined $5.7M, executive charged, for covering up patient deaths
The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time.

Novartis building massive new radioligand manufacturing facility as part of $23B investment in US

The 46,000 square foot Denton site will be the fifth Novartis has constructed stateside. The company expects it to be fully operational by 2028.

FDA announces recall on infusion systems after software anomaly injures 2 patients

The recall has been designated as the most serious, Class I, but the issue can be remedied with a software update. The affected devices are Ivenix Large Volume Pumps manufactured by Fresenius Kabi.

Vintage neon drug sign at the Walgreens pharmacy on Canal Street in downtown New Orleans.

Walgreens cuts 628 jobs and closes distribution facility, alarming private equity watchdog

Sycamore Partners took over the struggling retail pharmacy chain roughly six months ago, and the Private Equity Stakeholder Project fears early staffing cuts and store closures could spell trouble for the long-term health of the newly restructured business.

Ohio health system sued by DOJ over alleged antitrust violations related to payer contracts

The U.S. Department of Justice and the state attorney general's office allege OhioHealth used its position of market dominance to pressure commercial plans into always keeping its hospitals and clinics in-network, even when competitors offer services for a better rate.

Moderna, FDA reach compromise to accelerate approval of mRNA flu vaccine

The dispute centered around the pharmaceutical company's request for the shot to be approved for those aged 65 and over, a demographic the FDA argued was not properly represented in a 40,000-person clinical study. The company has agreed to perform additional research after the shot goes to market, having appeased regulators with safety data.

Federal court strikes down FTC mergers and acquisitions reporting rule

A U.S. District Court in Texas ruled that the agency overstepped its regulatory authority in passing the 2024 Biden-era reporting requirement, which would require stakeholders to spend more than 100 hours filling out a long form to give the agency more oversight of transactions.

Rosabella Moringa FDA recall supplement salmonella

FDA investigating outbreak of ‘extensively’ antibiotic resistant salmonella linked to supplement

Capsules of moringa tree leaf, branded as Rosabella, are being recalled after seven states report cases of the illness, with three patients saying they took the supplement. The company has issued an emergency recall.

CT findings linked with pancreatic cancer

FDA approves medical device for pancreatic cancer therapy—the first new treatment in 30 years

Developed by Novocure, the portable Optune Pax system uses tumor treating fields aimed directly at the site of the cancer to disrupt cell reproduction. A Phase 3 clinical trial shows it improves survival by two months on average versus chemotherapy alone.

Business Intelligence

FDA merges all adverse event reporting systems into new AEMS platform

Medical device manufacturer hit by cyberattack, possibly from Iranian-backed hackers

Medicare Advantage fraud allegations against Aetna settled for nearly $118M

FTC seeks more time to settle insulin pricing lawsuit with remaining PBM defendants

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths