STAT

JANUARY 7, 2025

As of last October, the agency had received more than 500 drug submissions with AI components going back to 2016, with a large number in the areas of oncology, neurology, and gastroenterology. The guidance comes as drug regulatory submissions citing AI have increased exponentially.

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Compounding Documentation 252

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OCTOBER 18, 2023

It joins the original San Francisco Biohub founded in 2016 and a Chicago Biohub founded earlier this year. Read the rest…

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JULY 22, 2024

The report , which was released in March but received little if any public attention, examined drug spending between 2016 and 2021 within the health plan that covers more than 200,000 unionized mail carriers and post office workers, as well as retirees.

Pharmaceutical Companies 363

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 363

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OCTOBER 10, 2022

I first met Wes Ely in 2016, when I wrote about ICU delirium and Ely’s attempts, as a critical-care physician at Vanderbilt University Medical Center, to urge fellow health care workers to rethink the use of heavy sedation in ICUs. Well, a lot’s happened since 2016.

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Hospitals 295

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SEPTEMBER 19, 2023

WASHINGTON — Rep. Adam Smith (D-Wash.) knew when he hit rock bottom.

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FEBRUARY 6, 2024

In the eight years between the drug’s spectacular 2016 debut on the cover of Nature and its ignominious end , Biogen made multiple, really bad decisions. Its decision, the company explained, is not a response to new data about the drug’s safety or efficacy, but instead “a reprioritization of resources.”

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JUNE 13, 2024

With some of the highest obesity levels in South America, the country had begun enforcing strict regulations on Frosted Flakes and other foods that exceeded set thresholds for sugar, calories, salt, or saturated fat in 2016. Read the rest…

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NOVEMBER 20, 2024

In 2016, the Arkansas Legal Aid Center was flooded with calls. People on a Medicaid program that provided in-home care assistance were having their caregiving hours cut. Reducing the hours for somebody with quadriplegia or cerebral palsy was devastating, said Kevin De Liban, an attorney with the organization at the time.

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DECEMBER 27, 2023

Philips Respironics, a subsidiary of Philips, allegedly gave out masks from 2016 to 2021. The masks, according to a press release from the Department of Justice, were used to diagnose and treat sleep disorders. The case never went to court. The DOJ says Philips violated the Anti-Kickback Statute as well as the False Claims Act.

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SEPTEMBER 21, 2023

Intarcia started developing its lead therapy, a small, skinny bar implanted under the skin, for type 2 diabetes patients in 2016. The agency is not bound to advisory panel decisions, though it tends to follow their advice.

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Diabetes 353

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SEPTEMBER 5, 2023

The appointment follows a bitter board fight that ended with the departure of Francis deSouza, who had been Illumina’s CEO since 2016. Illumina, the largest maker of DNA-sequencing technology and a storied name in the biotechnology industry, named Jacob Thaysen, a 10-year-veteran at life sciences-tools firm Agilent, as its new CEO.

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NOVEMBER 3, 2022

The original guidelines , issued in 2016, helped further drive down opioid prescribing levels that had been in decline since 2012, as the country grappled with its legacy of overprescribing that contributed to the overdose epidemic.

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OCTOBER 18, 2024

billion in 2016. Since it began more than 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $38 billion in prescription medications were purchased under the 340B program in 2020, for instance, which was up from $16.2 Continue to STAT+ to read the full story…

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Hospitals Drug Pricing 324

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JUNE 10, 2024

Women generally made up just 33% of participants when the team reviewed 195 trials published from 2016 to 2022.   In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020.   The issue isn’t new.

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JANUARY 10, 2024

This latest revision, known as the DSM-5-TR, was prepared between 2016 and 2019, and published in 2022. -based physicians who helped assemble a recent revision of the Diagnostic and Statistical Manual of Mental Disorders, which is often referred to as the bible of psychiatry.

Pharmaceutical Companies 363

Pharmaceutical Companies Pharmaceutical Companies 363

STAT

APRIL 5, 2024

The company earned its first clearance from the Food and Drug Administration in 2016 , and went public in 2019 at a share price of $17.  According to a press statement, Shockwave has treated 400,000 patients with this method globally.

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FEBRUARY 13, 2024

They’re investing in insurance brokerages, marketers, in-home assessment companies, and “insurtechs,” the report said, based on a new analysis of deals in the space since 2016.

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DECEMBER 14, 2022

When he was hospitalized in August 2016, hospital staff used a needle to drain 7 liters of fluid from his abdomen. The final years of Carl Hoffer’s life were, in his words, “living hell.” ” His legs were so swollen they’d crack and leak white fluid. Read the rest…

Hospitals 252

Hospitals 252

STAT

MARCH 20, 2025

In 2016, Ionis won approval for an infusion called Spinraza.  Yet there were many older children and even some adults with debilitating but more mild disease who might be treated. Much  Much has changed, though, since Zolgensma’s earliest trials. After Zolgensma was approved, Roche won approval for a pill.

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Compounding Pharmacies Compounding Dosage 248

STAT

JANUARY 18, 2024

In 2016, the 21 st Century Cures Act required that the U.S. make progress toward interoperability, which it defined as “all electronically accessible health information” to be accessed, exchanged and used “without special effort on the part of the user.”

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DECEMBER 17, 2023

Illumina, a storied name that had delivered investors strong returns over two decades, spun out Grail in 2016 in order to raise money to fund the company’s work. The decision opens what should be the final chapter in one of the most disastrous attempted mergers in biotech history. Then, it announced plans to re-acquire the firm for $7.1

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APRIL 19, 2024

They examined data spanning January 2016 through June 2021 at 619 U.S. “There is an urgent need to understand why clinicians at hospitals with access to newer agents do not always prefer newer agents,” the researchers wrote in the Annals of Internal Medicine. Continue to STAT+ to read the full story…

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Hospitals 340

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DECEMBER 13, 2023

In 2016, a trial for a hormonal male birth control pill was halted after men reported side effects including acne and mood swings — though such side effects are also experienced by women on various hormonal contraceptives. Attempts to change the status quo have been scarce and unsuccessful.

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FEBRUARY 17, 2023

Although that annual growth rate is the lowest since 2016, the private plans now catch roughly half of the entire Medicare population. million seniors and people with disabilities are now enrolled in a private Medicare plan, known as Medicare Advantage, according to new federal government data analyzed by STAT. That total is 7.1%

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OCTOBER 30, 2023

But Bristol stumbled in 2016 when its immunotherapy Opdivo failed to help patients with non-small cell cancer more than chemotherapy. Opdivo remained a big seller, but its failure allowed Merck’s rival Keytruda to move into position to become the best-selling medicine in the world.

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Chemotherapy 337

STAT

SEPTEMBER 29, 2023

In 2016, 340B sales were $16.2 Since it began 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $44 billion in medicines were purchased under the 340B program in 2021, which was up from $38 billion the previous year. Continue to STAT+ to read the full story…

Hospitals 303

Hospitals 303

STAT

MARCH 23, 2023

Directly observed  therapy — where a health professional watches someone take a medication — has been the standard of care for tuberculosis treatment in the United States since 2016. Now DOT, as it’s called, has an approved video alternative.

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MAY 17, 2024

In 2016, when Simmone Taitt had her first pregnancy loss, she was very well insured, had a high-paying job as a tech executive, and had access to one of the top OB-GYNs in New York City. When Black people receive maternal care, they are often not treated the same as white people.

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SEPTEMBER 7, 2022

Good Therapeutics, a private company that raised just $30 million in venture financing since its 2016 foundation, said Wednesday it had signed a deal to sell itself to Roche for $250 million without ever running a clinical trial.

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MAY 11, 2023

Thanks to changes in tax law six years ago, several of the largest pharmaceutical companies saw their tax rates fall substantially, but they also reported that most of their profits were shifted offshore in an effort to avoid paying U.S. taxes, according to a memo by a U.S. Senate Committee. in 2020, down from 19.6%

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Pharmaceutical Companies Pharmaceutical Companies 252

STAT

NOVEMBER 7, 2023

The FDA previously moved to withdraw approval of the antibiotic in 2016 over carcinogenicity , but the manufacturer, Phibro Animal Health, fought the effort by arguing, in part, that its drug is medically necessary.

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DECEMBER 13, 2022

Founded in 2016, BehaVR is currently pursuing multiple avenues for commercializing therapeutic virtual reality, including partnerships with Japanese drugmaker Sumitomo Pharma and musculoskeletal care conglomerate Confluent Health.

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OCTOBER 5, 2022

After the brain tumor diagnosis in 2016, Gatton would undergo two brain surgeries, radiation treatment, chemotherapy, followed by an embryo transfer that failed. She was rushed to the hospital, where doctors diagnosed the then 29-year-old with a brain tumor.

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FEBRUARY 23, 2023

” The probe covers everything from January 2016 to the present day. attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insurers regarding the AKF.” Continue to STAT+ to read the full story…

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Communication Documentation 246

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MAY 9, 2023

It will be the first FDA advisory panel hearing for a Duchenne drug from Sarepta since 2016, when hundreds of patients and family members traveled to the FDA campus in Maryland to plead with experts to authorize an earlier therapy from the company despite limited evidence.

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FEBRUARY 13, 2023

Humira’s main patent expired in 2016, but a byzantine patent saga has kept other drugmakers from offering their own version of the monoclonal antibody used to treat conditions such as rheumatoid arthritis and Crohn’s disease. Humira has been the world’s best-selling medicine since it arrived on the market in 2002.

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Biosimilars 246

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MAY 15, 2024

Abbott’s first dissolvable stent, for coronary artery disease, received Food and Drug Administration approval in 2016. It also delivers a drug that prevents scar tissue from forming — a common risk factor with traditional metal stents that further narrow the vessel.

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