Category: Medical Devices

This brief reviews the status of state actions to strengthen and guarantee abortion access to their residents, as well as to prepare for the likely increase in demand for abortion services in those states should the high court overturn the constitutional right to abortion established by Roe v. Wade.

In early April, when word began to circulate that hospitals in the United Kingdom were seeing unexplained hepatitis cases in very young children, some physicians and researchers on this side of the Atlantic experienced a moment of déjà vu.

Kevin Messacar and colleagues at Children’s Hospital Colorado found themselves remarking on how reminiscent the unfolding investigation was of a medical mystery they’ve been enmeshed in for the past eight years — acute flaccid myelitis, or AFM, a polio-like condition in children.

Read the rest…

The Food and Drug Administration said Friday it had approved Mounjaro, a new injection for type 2 diabetes made by Eli Lilly that lowers blood sugar and can help patients lose weight.

The agency emphasized in a press release that in clinical trials Mounjaro was more effective than other treatments that were studied.

Read the rest…

RaDonda Vaught, a former nurse in Tennessee, was sentenced on Friday to three years of supervised probation after being convicted in March of making a fatal medication error in 2017, which resulted in the death of a patient under her care. Although Vaught isn’t being sent to prison, her conviction and sentencing, meted out for the kind of error that routinely occurs in health care institutions across the U.S., are a true travesty of justice.

That’s a far cry from what happened to William Husel, a former Ohio physician, who was acquitted of murder in April for hastening the deaths of 14 critically ill patients under his care by ordering doses of the painkiller fentanyl that were 10 times the amount ordinarily ordered for critically ill patients. Husel knowingly, and with intent, ordered the inordinate dosage of medication to patients across the lifespan — from their late 30s to their 80s — with a variety of ailments ranging from pneumonia to cancer.

Read the rest…

Is the next Covid surge upon us? How do you make $350,000 a day in biotech? And when did Seagen find out about its CEO’s arrest?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss the latest alarming trends in the Covid-19 pandemic and explaining the curious case of Moderna’s briefly employed chief financial officer. Then we pick apart the implications of Pfizer’s $11.6 billion acquisition of Biohaven and the struggles of a once-promising idea in cancer immunotherapy. Finally, we examine the arrest of Seagen CEO Clay Siegall and the unanswered questions about the company’s response.

Read the rest…

The merger of Advocate Aurora Health and Atrium Health, announced Wednesday, would create one of the country’s biggest nonprofit hospital systems with $27 billion in revenues and a sprawling network of facilities in far-flung states — and likely will draw scrutiny from federal regulators. 

There’s no obvious legal path for them to block the massive deal, which would combine two systems that operate not only in different states, but in different regions of the country. Attorneys and antitrust experts say the Federal Trade Commission has never taken legal action to block a merger between hospital systems that operate in distinct markets, known as a cross-market merger, although it has evaluated the possibility. 

Continue to STAT+ to read the full story…

After 18 months, the fate of a contentious proposal before the World Trade Organization to temporarily waive patent rights for Covid-19 medical products still remains uncertain. The effort was initiated by South Africa and India to widen access to poor countries after wealthy nations quickly locked in supplies for vaccines when the pandemic began more than two years ago. But the pharmaceutical industry has continually balked at the provisions. India and South Africa recently reached a compromise with the U.S., which backs a waiver only for vaccines, and with the European Union.

But the latest version, which was released last week, has angered many public health advocates, who argue the language would actually accomplish little. Whether agreement can be reached by mid-June, when the WTO Ministerial Conference takes place, is unclear.

Continue to STAT+ to read the full story…

The ticker tape of the infectious disease world, ProMED, posts a steady stream of reports about unusual outbreaks.

Few cases become big news. But on the eve of 2020, STAT senior writer Helen Branswell noticed an item out of China. “Hopefully this is nothing out of the ordinary,” tweeted Branswell, who had covered the 2003 SARS outbreak in Toronto. “But a @ProMED_mail posting about “unexplained pneumonias” in China is giving me #SARS flashbacks.”

Read the rest…

WASHINGTON — An oversight board tasked with making the National Institutes of Health more efficient and more effective mysteriously stopped meeting seven years ago, according to a STAT review of agency records — and its members don’t know why.

The group, which Congress created in 2006, was intended to serve as a sounding board for the NIH director, providing periodic feedback and recommendations aimed at improving the government’s largest science agency. But it hasn’t met since the summer of 2015, and several prominent researchers whom the NIH website still lists as board members appear confused as to whether the group still exists.

Continue to STAT+ to read the full story…

What does a breakout company like Moderna do for an encore? More than a decade after its founding, the Cambridge biotech rolled out its first commercial product last year. And what a debut it was: a cutting-edge COVID-19 vaccine that helped to save thousands ― if not millions ― of lives around the world.

It was also a massive moneymaker for Moderna, which up until then had been unprofitable. With more than $38 billion in total COVID-19 vaccine sales expected by the end of this year ― many of the doses paid for by governments ― investors are wondering what the company plans to do with that windfall. Despite Moderna’s spectacular success, the question of what’s next looms large, and the pressure is on to avoid becoming a one-hit wonder.

Continue to STAT+ to read the full story…