Day: July 14, 2021

STAT+: Senate Democrats eye drug pricing policies to fund $3.5 trillion budget deal

WASHINGTON — Senate Democrats intend to include several drug pricing policies in their $3.5 trillion partisan push to pass a slew of major Biden administration priorities, according to a framework of the draft package obtained by STAT. The draft suggests that certain drug pricing provisions could be used to help offset the costs of other, […]

Researchers use machine learning to translate brain signals from a paralyzed patient into text

Assistive technologies such as handheld tablets and eye-tracking devices are increasingly helping give voice to individuals with paralysis and speech impediments who otherwise would not be able to communicate. Now, researchers are directly harnessing electrical brain activity to help these individuals. In a study published Wednesday in the New England Journal of Medicine, researchers at […]

With fewer than 400 progeria patients worldwide, testing a CRISPR cure will be challenging

When Sammy Basso was diagnosed with progeria at 2, it seemed likely that the disease’s hyper-accelerated aging would kill him before he graduated high school. “There was nothing. Nothing. No cure, of course, no treatments, no information. It was catastrophic,” said Basso, spokesperson for the Progeria Research Foundation, at STAT’s Breakthrough Science Summit on Wednesday. […]

FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval 

WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its controversial approval of a new Alzheimer’s drug. She was emphatic in her defense of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said, “it’s […]

STAT+: FDA scolds Amgen over a misleading ad that could deter use of biosimilar versions of its drug

In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over a drug advertisement that made misleading claims and, as a result, might confuse physicians and thwart the use of lower-cost biosimilar versions. The agency noted that a banner ad for the Neulasta bone marrow stimulant cited a study claiming there is […]

STAT+: Pharmalittle: Half-dozen big insurers won’t cover new Alzheimer’s drug; Medicaid could spend up to $2.2 billion on the Biogen drug

Good morning, everyone, and how are you today? The sun is trying to peek through a muggy haze descending this morning on the Pharmalot campus, where our official mascot is lounging about and assorted birds and bugs can be heard in the distance. As for us, we are immersed in our usual routine of foraging […]

Opinion: Listen: An OB-GYN on the maternal mortality crisis in the U.S.

Why do more women die in and after childbirth in the U.S. than in any other industrialized nation? In this week’s episode of the “First Opinion Podcast,” physician Alissa Erogbogbo argues that the only way the country can change this sad state of affairs is by addressing the inherent biases and inequities of traditional health […]

STAT+: ‘’This is unprecedented’: Several private insurers won’t cover Biogen’s Alzheimer’s drug

At least half-a-dozen private health insurers in some of the nation’s largest states are balking at covering Biogen’s controversial drug for Alzheimer’s disease, saying it is an experimental and unproven treatment despite being approved by the federal government one month ago. Six affiliates of Blue Cross and Blue Shield in Florida, New York, Michigan, North […]

Extending the reach of gene therapies means hurdling not just scientific barriers but prices, too

While Covid-19 struck a blow to a vast number of clinical trials around the world, the pandemic may turn out to be a boon for bringing gene therapies to more people in the coming years. “Who would have predicted three years ago that we’d now be having billions of doses manufactured of mRNA packaged in […]

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