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 255

Documentation 255

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

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

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

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Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.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

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…

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Documentation 244

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 358

Documentation 358

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 340

Documentation 340

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 312

Documentation 312

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

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

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 271

Documentation Hospitals 271

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

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

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 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

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 123

Documentation 123

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 363

Documentation 363

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 343

Hospitals Documentation 343

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 323

Documentation 323

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 299

Documentation 299

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 343

Documentation Vaccines 343

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

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 363

Documentation 363

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…

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Vaccines Documentation 320

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 364

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 362

Hospitals Documentation 362

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 358

Documentation 358

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 361

Documentation 361

STAT

APRIL 25, 2024

A series of recent research papers by academic hospitals has revealed significant limitations of large language models (LLMs) in medical settings, undercutting common industry talking points that they will save time and money, and soon liberate clinicians from the drudgery of documentation.

Documentation 361

Documentation Hospitals 361

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 296

Documentation 296

STAT

FEBRUARY 22, 2024

Federal investigators asked CHS to hand over documents that covered “practices and procedures related to utilization review, inpatient admissions, and inpatient dialysis at our hospitals.”

Hospitals 336

Hospitals Inpatient Documentation 336

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 364

Documentation Vaccines 364

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 363

Pharmaceutical Manufacturing Documentation 363

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

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 363

Biosimilars Drug Pricing Documentation Pharmaceutical Companies 363