STAT

MAY 1, 2024

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

Documentation 363

Documentation Nursing Homes 363

STAT

JANUARY 22, 2025

The rise of large language models that can efficiently summarize text has fueled the rapid development of companies using the technology to take documentation burden off overworked clinicians. Then, the provider must go through and add or edit the text that the Eleos software generated to their final note.

Documentation 329

Documentation 329

STAT

MAY 10, 2023

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.

Documentation 254

Documentation 254

STAT

APRIL 13, 2025

In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.

Specialty Pharmacies 363

Specialty Pharmacies Documentation Drug Pricing 363

STAT

JULY 15, 2024

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT.

Documentation 363

Documentation 363

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

Documentation 254

Documentation 254

STAT

MAY 6, 2024

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals.

Documentation 363

Documentation 363

STAT

APRIL 12, 2023

The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive. Read the rest…

Documentation 246

Documentation 246

STAT

JANUARY 29, 2024

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.

Documentation 364

Documentation 364

STAT

MAY 31, 2024

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans.

Documentation 364

Documentation 364

STAT

OCTOBER 27, 2023

The Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to evaluate the risk of inadvertently making unwanted changes to patients’ DNA.

Documentation 357

Documentation 357

STAT

APRIL 14, 2025

Canadian officials have obtained a court order that requires Express Scripts to produce documents in connection with an investigation into whether the pharmacy benefits manager violated antitrust laws. The Competition Bureau is examining whether the company forced or induced Canadians to use its own pharmacies.

Mail-Order Pharmacies 273

Mail-Order Pharmacies Documentation Drug Pricing 273

STAT

FEBRUARY 18, 2025

Abridge, which has emerged as one of the leaders amid the boom in companies using technology to streamline clinical documentation, announced today it has over 100 health system customers, including big names like Duke Health, Johns Hopkins, and Mayo Clinic. Read the rest…

Mayo Clinic 241

Mayo Clinic Documentation 241

STAT

APRIL 9, 2025

Two decades ago, when I first began practicing emergency medicine, patient documentation was a manual process. I would write on carbon-copy forms that were later stored in the belly of the hospital, in archives, as patient files.

Documentation 257

Documentation Communication Hospitals 257

STAT

MARCH 20, 2024

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

Documentation 344

Documentation 344

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 309

Documentation 309

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 246

Vaccines Documentation 246

STAT

SEPTEMBER 18, 2024

billion, according to STAT’s analysis of financial documents the health system released Tuesday evening. The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 Continue to STAT+ to read the full story…

Hospitals 360

Hospitals Documentation 360

STAT

DECEMBER 28, 2023

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT.

Nursing Homes 364

Nursing Homes Documentation 364

FDA Law Blog: Biosimilars

APRIL 21, 2025

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.

Documentation 64

Documentation Drug Development 64

FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

Documentation 144

Documentation Labelling Drug Development 144

STAT

FEBRUARY 15, 2024

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government.

Documentation 363

Documentation 363

STAT

DECEMBER 14, 2022

An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies. Hospice in America is gravely ill. Read the rest…

Documentation 364

Documentation 364

STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

Documentation 363

Documentation 363

BioPharma Dive

MAY 10, 2023

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

Documentation 122

Documentation 122

STAT

NOVEMBER 20, 2023

Financial documents at a prominent hospital system in Los Angeles show just how large those discounts are — and how raw of a deal uninsured patients could be getting. 30, according to new financial documents. Hospitals’ list prices for surgeries, therapies, and other procedures always come with massive discounts.

Hospitals 342

Hospitals Documentation 342

STAT

OCTOBER 25, 2023

Novartis has gone to court to gain access to Takeda Pharmaceutical documents over concerns that a former employee took trade secrets with him to his new job at the rival drugmaker. Continue to STAT+ to read the full story…

Documentation 300

Documentation 300

STAT

APRIL 26, 2024

New federal rules aimed at limiting the spread of the H5N1 bird flu virus among dairy cattle go into effect Monday, but detailed guidance documents released Friday by the U.S. Department of Agriculture reveal its mandatory testing order is less stringent than initially described.

Documentation 364

Documentation 364

Express Pharma

APRIL 9, 2025

Logistics4Pharma, a GDP-certified pharmaceutical logistics provider based in Frankfurt, has expanded its service offerings by integrating a comprehensive transit document service with customs-secured transportation into its existing portfolio. This addition builds on the companys existing temporary storage services under customs supervision.

Customer Service 52

Customer Service Documentation 52

STAT

OCTOBER 4, 2023

It’s the end of an era for a once-critical pandemic document: The ubiquitous white Covid-19 vaccination cards are being phased out. Now that Covid-19 vaccines are not being distributed by the federal government, the Centers for Disease Control and Prevention has stopped printing new cards. Read the rest…

Vaccines 318

Vaccines Documentation 318

STAT

NOVEMBER 4, 2023

In these annual letters, I usually talk proudly about all we have accomplished, from our singular coverage of the Covid pandemic to our years-in-the-making court victory to force Purdue Pharma to release documents about its OxyContin marketing efforts, to our success at becoming the go-to media outlet covering health and medicine.

Documentation 360

Documentation 360

STAT

JUNE 20, 2024

  That decision, documents concurrently released by the agency show, was made almost exclusively by Peter Marks, the agency’s director of the Center for Biologics Evaluation and Research.

Documentation 363

Documentation 363

STAT

SEPTEMBER 10, 2024

The group recently published a study in The Lancet documenting their success using gene therapy to treat an inherited retinal blindness that affects as many as 100,000 people globally. Seven years after the FDA approved Luxterna , scientists have yet to bring another congenital blindness treatment to the market. Read the rest…

Documentation 294

Documentation 294

STAT

JANUARY 7, 2025

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency.

Compounding 254

Compounding Documentation 254

STAT

OCTOBER 22, 2024

But Novo argued that semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, should be on the FDA’s “Demonstrable Difficulties for Compounding Lists,” which are lists of complex medications that compounders are not allowed to make regardless of shortages, according to documents the agency posted this week.

Compounding 362

Compounding Compounding Pharmacies Documentation Diabetes 362

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 98

Documentation Inpatient 98

STAT

MAY 1, 2024

Democrats, in a separate report, did not go that far but said that documents and testimonies “raise reasonable questions” about the organization receiving any future taxpayer funding. federal agencies.

Documentation 363

Documentation 363