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 343

Documentation 343

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 343

Documentation 343

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 363

Documentation 363

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 204

Documentation 204

STAT

SEPTEMBER 19, 2024

Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India.

Documentation 196

Documentation Generic Medicine 196

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Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

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Documentation 194

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 298

Documentation 298

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 183

Documentation 183

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 282

Documentation 282

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 363

Nursing Homes Documentation 363

STAT

DECEMBER 16, 2022

My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy.

Documentation 251

Documentation Hospitals 251

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 246

Documentation 246

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 345

Documentation 345

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 363

Documentation 363

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.

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Documentation 320

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.

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Documentation 123

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 207

Vaccines Documentation 207

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 308

Hospitals Documentation 308

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 340

Documentation 340

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.

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Documentation Inpatient 98

STAT

APRIL 30, 2024

The H5N1 bird flu virus has been around for decades, and the damage it wreaks on chickens and other poultry is well documented. But the recent discovery that the virus has jumped into dairy cattle — whose udders seem to be where the virus either infects or migrates to — has dumbfounded scientists and agricultural authorities.

Documentation 362

Documentation 362

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

Documentation 314

Documentation Vaccines 314

STAT

OCTOBER 16, 2024

But inside a UnitedHealth practice, the “#1 PRIORITY” became documenting older patients’ chronic illnesses to generate more revenue from the federal government, the emails show. . At the time, deaths from Covid-19 were surging, and no vaccine was available.

Documentation 363

Documentation Vaccines 363

STAT

MARCH 18, 2024

CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

Biosimilars 359

Biosimilars Drug Pricing Documentation Pharmaceutical Companies 359

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 274

Hospitals Documentation 274

STAT

JANUARY 11, 2024

Generative AI’s earliest applications in medicine have largely focused on curing not patients, but the plague of productivity physicians lose to digital documentation.

Documentation 311

Documentation 311

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.

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Compounding Compounding Pharmacies Documentation Diabetes 328

STAT

FEBRUARY 27, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.

Pharmaceutical Manufacturing 321

Pharmaceutical Manufacturing Documentation 321

STAT

JULY 31, 2024

Mount Sinai researchers had claimed, in a patient consent form and in documents submitted to the FDA and the National Institutes of Health, that patients in the study do not lose any additional tissue than they would during standard DBS, a procedure used to ease the symptoms of certain neurological conditions.

Documentation 345

Documentation Hospitals 345

STAT

NOVEMBER 14, 2023

Internal documents show that a UnitedHealth subsidiary called NaviHealth set a target for 2023 to keep rehab stays of patients in Medicare Advantage plans within 1% of the days projected by the algorithm.

Health Insurance Companies 364

Health Insurance Companies Documentation 364

STAT

MARCH 26, 2024

A price tag was not included in documents filed with the state, and Optum officials did not immediately respond to comment. On Tuesday, a subsidiary of Optum, Collaborative Care Holdings, LLC, filed notice with the state’s Health Policy Commission over the sale. Continue to STAT+ to read the full story…

Hospitals 302

Hospitals Documentation 302

STAT

OCTOBER 23, 2023

Starting in the first quarter of 2024, Optum’s post-acute-care companies will be called Home & Community Care, according to internal documents obtained by STAT. However, Optum advised employees that “Home & Community Care should not be directly next to the Optum logo” in marketing materials.

Documentation 345

Documentation Hospitals 345

STAT

SEPTEMBER 16, 2024

They dug into a decade of documents from the Food and Drug Administration to understand how devices recalled for their risk of serious injury or death were clinically tested before being used on patients.    In most cases, they simply weren’t.

Documentation 238

Documentation 238

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.

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Documentation 298

STAT

AUGUST 5, 2024

As documented in a recent commentary that I and several colleague published in the journal Frontiers in Research Metrics and Analytics, considerations of diversity, equity, and inclusion (DEI) have been introduced into federal science funding decisions.

Documentation 331

Documentation 331

STAT

NOVEMBER 14, 2023

Internal documents revealed that managers within the company set a goal for clinical employees to keep patients rehab stays within 1% of the days projected by the algorithm. The lawsuit filed in the U.S.

Nursing Homes 364

Nursing Homes Documentation 364

STAT

DECEMBER 4, 2023

  The document was supposed to help Novak, then the chief executive of CRISPR Therapeutics, navigate a pressing quandary. His company, along with two others, were founded to commercialize the new revolutionary gene-editing tool CRISPR-Cas9 , which promised to cure numerous genetic diseases.

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Documentation 318