STAT

SEPTEMBER 25, 2024

“And we definitely want to position Akeso as a global biotech, not just a China story.”    Now, Akeso’s leaders want you to know that its recent success isn’t a one-off.  ”  Continue to STAT+ to read the full story…

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STAT

SEPTEMBER 29, 2022

The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respond to outbreaks of rare and dangerous pathogens.

Vaccines 362

Vaccines 362

STAT

AUGUST 23, 2024

A diagnostics company has agreed to stop selling two questionable blood tests as part of a settlement with a consumer watchdog that accused the firm of using “false and misleading advertising” to promote the products. 

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STAT

JANUARY 18, 2024

Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. Long Covid has long eluded scientists looking for its cause.

Immunity 363

Immunity Immunization 363

STAT

AUGUST 14, 2024

By definition, sudden cardiac arrest seems to come out of nowhere. The most shocking cases are when young athletes collapse on the field, but this type of calamity also strikes dedicated middle-age runners, retirees whose health problems seemed well under control, adults of all ages and class.

Hospitals 362

Hospitals 362

The Pharmacist

AUGUST 2, 2024

The report on vaccine uptake urges NHS England to ‘adopt the same data integration standards applied for antibiotics, blood pressure checks and contraceptive prescriptions to all […] The post Report pushes for ‘advanced services’ definition for vaccinations in CPCF appeared first on The Pharmacist.

Vaccines 93

Vaccines Community Pharmacies 93

STAT

NOVEMBER 15, 2023

Those theories have never definitively been proven. Scientists at the Wuhan Institute of Virology studied gain-of-function in some viruses , fueling theories that the Covid-19 pathogen was a lab leak. Continue to STAT+ to read the full story…

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STAT

JANUARY 25, 2024

By definition, it’s a PBM. WASHINGTON — For an app that helps pharmacies in Africa manage their medicines, the term “pharmacy benefit manager” has become a dirty word. The organization, called Maisha Meds, plays the role of a middleman between international groups like USAID and the Gates Foundation and pharmacies.

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STAT

JUNE 4, 2024

We published an in-depth story on Friday about what to expect today , but here are the basics: MDMA is the first Schedule I psychedelic to be considered by the FDA — meaning that, if it’s approved, it would no longer meet the Drug Enforcement Administration’s Schedule I definition of having “no medical benefit.”

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STAT

JULY 19, 2024

But the bill’s definition of high-risk life sciences research is overly broad and ambiguous, and duplicative of existing regulations covering agents of bioterrorism concern and dual-use research.

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STAT

MAY 2, 2023

There was (and continues to be) a desperate hunger for definitive studies telling us how well specific measures would work, with specific publics, in specific settings, for specific strains of the novel and changing virus. Although the scientific community mobilized at record speeds, it could not produce studies with the desired surety.

Vaccines 345

Vaccines 345

PharmaTech

SEPTEMBER 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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STAT

DECEMBER 21, 2023

Chronic disease is, by its very definition, omnipresent. But changes year to year have the potential to make certain conditions into flaming-red targets for researchers and drugmakers.

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STAT

JANUARY 4, 2023

China is underreporting deaths from Covid-19, a senior official of the World Health Organization said Wednesday as he urged use of a broader definition that would more fully capture the mortality impact of the country’s first big wave of Covid infection.

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STAT

NOVEMBER 19, 2024

To start, FDA officials wrote in an executive summary shared before the meeting, it’s hard to know when it qualifies as a device under the agency’s definitions.     Why is it so hard to regulate generative AI products in medicine?   Continue to STAT+ to read the full story…

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STAT

FEBRUARY 24, 2023

medical profession has also come to distort the very definition of public health and what is now widely believed to constitute relevant knowledge. But the medical field’s corrosion of public health doesn’t stop at budgets and policies. Through its stranglehold on resources and institutional power, the U.S.

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STAT

JUNE 3, 2024

The two drugs have not been compared directly against each other and Bristol’s study used a different definition of transfusion response. Continue to STAT+ to read the full story…

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STAT

FEBRUARY 13, 2024

It had also done preliminary work on a similar but different drug — tenofovir alafenamide fumarate (TAF) — for which it had early, although not definitive, evidence for safety and efficacy. In the years that followed, the company invested in research leading to additional TDF-based regimens critical to the fight against HIV.

Drug Development 307

Drug Development 307

STAT

SEPTEMBER 15, 2024

A larger and more definitive study is still underway, and Exact expects to report results from that trial in the first half of next year and to then apply for Food and Drug Administration approval. Continue to STAT+ to read the full story…

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STAT

OCTOBER 17, 2023

The CUNY committee charged with investigating Cassava’s principal scientific collaborator, the neuroscientist Hoau-Yan Wang, could not definitively prove that Wang faked simufilam data, but that’s only because he refused to turn over original data and primary research records that the committee had requested to examine.

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STAT

JANUARY 25, 2024

The lawsuit further maintained the law offers “an extraordinarily vague definition” of price gouging. The trade group also contended the law violates the constitutional right to due process because the state has the right to file lawsuits over out-of-state transactions.

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STAT

MARCH 28, 2023

The new study results, while not definitive, bolster confidence that the drug could also prove effective for people with major depressive disorder and so-called mixed features. Sales of the Intra-Cellular drug, called Caplyta, tripled last year to $249 million. Continue to STAT+ to read the full story…

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STAT

OCTOBER 3, 2022

The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition. Continue to STAT+ to read the full story…

Documentation 262

Documentation Hospitals 262

STAT

FEBRUARY 24, 2023

In my studies with the world’s top medical statistics experts at the University of Oxford’s Centre for Evidence Based Medicine, I’ve also seen how flawed many datasets are, missing critical data pieces and definitions, and yet still used by the industry to make key decisions.

Pharmaceutical Companies 289

Pharmaceutical Companies Pharmaceutical Companies 289

STAT

DECEMBER 6, 2022

This annual project aims to be the most definitive accounting of impactful individuals in health, medicine, and science. Editor’s note: A livestream of the conversation will be embedded below at 2 p.m. This February, STAT published our first STATUS List. Some are well-known as changemakers; others are largely unheralded heroes.

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STAT

JANUARY 31, 2024

I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety. Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs.

Adverse Reactions 302

Adverse Reactions Labelling Hospitals 302

STAT

MARCH 14, 2023

After months of vigorous deliberations, I’m thrilled to announce our 2023 STATUS List — the definitive roster of leaders in health, medicine, and the life sciences whose work over the past year has advanced those fields. There were, of course, many contenders to choose from.

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STAT

DECEMBER 21, 2022

He’s smiley, silly, and definitely trying to make you laugh. Begay is a happy kid. The four-year-old’s two neat braids of dark hair wave behind him as he runs amongst the dust, dogs, and sheep near his family’s ranch on their Navajo reservation in Arizona.

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STAT

AUGUST 8, 2023

However, advocates have long argued that the tax code’s broad definition of community benefits has hospitals logging costs like physician training and research rather than direct community benefits like health screenings, free clinics, and care for the uninsured.

Hospitals 246

Hospitals 246

STAT

OCTOBER 17, 2024

The January response from the agency was definitive: The clinical evidence, including data from a randomized, placebo-controlled trial, failed to show that Attune helped patients. If Blue Note wanted clearance, the company would need to present more data.

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STAT

OCTOBER 28, 2022

One of the most pressing concerns involves what constitutes “regulatory grade” real-world data and real-world evidence, and when sponsors need to ensure that research conducted using data other than those generated via clinical trials meets the definition of regulatory grade. Continue to STAT+ to read the full story…

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228

STAT

DECEMBER 13, 2022

Until recently, there was no specific diagnostic code for or agreed-upon definition of the symptoms that linger after someone’s acute Covid infection has faded. Read the rest…

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STAT

AUGUST 23, 2023

Additionally, Apellis confirmed one additional case of the severe and potentially blinding side effect, known as retinal occlusive vasculitis, or ROV, that occurred in May.

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STAT

JULY 6, 2023

Those drugs have demonstrated an ability to help people lose dramatic amounts of weight in clinical trials, but payers, including Medicare, have been slow to reimburse for them without definitive data on their long-term health benefits. Continue to STAT+ to read the full story…

Diabetes 246

Diabetes 246

World Pharma News

OCTOBER 27, 2023

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the entry into a definitive agreement to acquire Telavant Holdings, Inc. Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc.

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85

BioPharma Dive

JANUARY 2, 2024

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

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143

STAT

SEPTEMBER 20, 2022

This annual project aims to be the most definitive accounting of impactful individuals in health, medicine, and science. Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. This February, STAT published our first STATUS List. Some are well-known as changemakers; others are largely unheralded heroes.

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