Definition - Pharmacist Digest

The official definition of infertility now includes LGBTQ+ and single people

STAT

OCTOBER 24, 2023

Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.

Opinion: I study diet and chronic illness. Here’s the uncomfortable truth about seed oils

STAT

MAY 20, 2025

But here’s the uncomfortable truth: The scientific community has not definitively determined the health effects of high seed oil consumption. Critics of seed oils are often accused of spreading fear or misinformation — and sometimes those concerns are justified. Read the rest…

STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

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…

Covid ignited a global controversy over what is an airborne disease. The WHO just expanded its definition

STAT

APRIL 18, 2024

In the chaotic first few months of the Covid-19 pandemic, stores faced shortages of all kinds — toilet paper, canned food, and especially, cleaning supplies. With everyone scrubbing their groceries, mail, even library books, good luck finding antibacterial wipes or disinfectant sprays back then.

Opinion: What does it mean to be ‘in recovery’? We need a better federal definition

STAT

JULY 11, 2023

” Though he was a formidable philosopher and logician, Carroll likely would be stymied by the circular logic that justifies the definition of “recovery” currently used to support critical federal substance use disorder programs and activities. Read the rest…

New definition of a human embryo proposed amid rapid scientific advances

STAT

AUGUST 17, 2023

When someone says the word embryo, what do you think of? Probably that picture you’ve seen a thousand times on a thousand different news articles: a translucent orb swelling with cytoplasm being prodded by a microinjection needle under the light of a microscope.

Opinion: The definition of clinical trial diversity must include disabled people

STAT

AUGUST 17, 2023

There are people in your life who influence and shape how you see the world. For me, one of these people is Terry Moakley, a warm and welcoming family friend, a veteran of the Vietnam War, and a fervent advocate for people with disabilities.

Inside the bruising battle to purge race from a kidney disease calculator

STAT

SEPTEMBER 4, 2024

And they were definitely failing. There it was on James Cannon’s lab report, two tiny words: African American. The words sat next to a number estimating how badly Cannon’s kidneys were failing. His number read 37, less than half of what is considered normal for adults.

Labelling

STAT+: The little-known Chinese biotech whose cancer drug beat Keytruda has global ambitions

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…

Ebola experimental vaccine trial may begin soon in Uganda

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

STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

JANUARY 7, 2025

The wastewater continued to contain high concentrations of organofluorines and other compounds that meet the definition of PFAS even after treatment. Oganofluorines — a group that includes per- and polyfluoroalkyl substances, or PFAS — were found in wastewater in eight large municipal treatment plants.

Compounding

Compounding Documentation

Settlement blocks diagnostics maker EpicGenetics from selling two questionable blood tests

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.

STAT+: Sudden cardiac arrest requires luck to survive. Scientists hope to turn those odds around

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

Opinion: ‘Ultra-processed food’ is too broad a term to be useful

STAT

FEBRUARY 25, 2025

Legislatures, governors, government agencies, and plaintiff attorneys are taking action against ultra-processed foods, but there is no clear definition of ultra-processed foods and there is little discussion of their benefits.

Diabetes

Opinion: The ‘Risky Research Review Act’ would do more harm than good

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.

STAT+: House moves to limit so-called gain-of-function research

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…

Report pushes for ‘advanced services’ definition for vaccinations in CPCF

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

Vaccines Community Pharmacies

Could long Covid’s signs of immune dysregulation in the blood lead to a diagnostic test?

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

Immunity Immunization

Why MAHA wants whole milk back on the table

STAT

JUNE 20, 2025

” For better or worse — definitely worse , health experts say, in the case of raw milk — Americans seem to be approaching a new chapter in their relationship with dairy. “Do you know what was up with that?” Agriculture Secretary Brooke Rollins has suggested the forthcoming U.S.

STAT+: Tracking the FDA advisory panel on MDMA therapy for PTSD

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.”

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

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.

Obesity drugs’ next tests, and rising threats: 3 chronic disease stories to watch

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.

STAT+: A PBM in Africa flips the industry’s script in a bid to make people healthier

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.

STAT+: It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials

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.

Opinion: Fixing U.S. public health will require a health-systems revolution — and for physicians to take a backseat

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.

STAT+: Exact Sciences reports initial positive results in colon cancer blood test, but pivot trial still pending

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…

STAT+: With new study data, Intra-Cellular could expand use of approved mood-disorder treatment

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…

STATUS List Spotlight: A Conversation with Otis Brawley

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.

STAT+: Agios drug reduces blood transfusions in patients with beta-thalassemia, study shows

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…

Opinion: Needed: a new framework to make sure health companies play fair with patient data

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

Pharmaceutical Companies Pharmaceutical Companies

A letter from the executive editor: The 2023 STATUS List

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.

Obesity needs a new definition, says global commission

pharmaphorum

JANUARY 15, 2025

Experts think the current way of defining obesity based on BMI isn't nuanced enough to gauge health and the need for weight-loss therapies.

Gene therapy trial shows promise for treating ‘bubble boy’ syndrome. Now comes the hard part

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.

Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

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

Senators push IRS to launch nonprofit hospital probe

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

Roche enters into a definitive agreement to acquire Telavant including rights to novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant

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.

Opinion: STAT+: The need for regulatory grade evidence: Are you in the stadium or the sandbox?

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…

STAT+: Generic group sues Illinois over a price-gouging law with ‘draconian regulations’

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.

STAT+: For this cancer-focused digital health startup, an FDA rejection meant the end of the road

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.

Bipolar disorder: how lithium as a treatment fell out of favour

The Guardian - Pharmaceutical Industry

NOVEMBER 9, 2024

On the lithium, I definitely feel like me,” she says. She was put on the antipsychotic drug olanzapine and another mood stabiliser, lithium. She has now been taking lithium alone for a year, and it has been transformative. “On Continue reading.

STAT+: Apellis safety probe of eye disease drug identifies injection needle as possible cause of severe side effect

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.

STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

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

Adverse Reactions Labelling Hospitals

A biopharma doubles down on diversity goals through a newly created position

PharmaVoice

JULY 1, 2025

I wanted to create a shared definition of patient centricity here at Ardelyx, and then weave that into the fabric of the organization." I wanted to create a shared definition of patient centricity here at Ardelyx, and then weave that into the fabric of the organization,” she said.

Drug Development

STAT+: What to know about this summer’s landmark Wegovy heart health study

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

The official definition of infertility now includes LGBTQ+ and single people

Opinion: I study diet and chronic illness. Here’s the uncomfortable truth about seed oils

Trending Sources

STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

Covid ignited a global controversy over what is an airborne disease. The WHO just expanded its definition

Opinion: What does it mean to be ‘in recovery’? We need a better federal definition

New definition of a human embryo proposed amid rapid scientific advances

Opinion: The definition of clinical trial diversity must include disabled people

Inside the bruising battle to purge race from a kidney disease calculator

STAT+: The little-known Chinese biotech whose cancer drug beat Keytruda has global ambitions

Ebola experimental vaccine trial may begin soon in Uganda

STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

Settlement blocks diagnostics maker EpicGenetics from selling two questionable blood tests

STAT+: Sudden cardiac arrest requires luck to survive. Scientists hope to turn those odds around

Opinion: ‘Ultra-processed food’ is too broad a term to be useful

Opinion: The ‘Risky Research Review Act’ would do more harm than good

STAT+: House moves to limit so-called gain-of-function research

Report pushes for ‘advanced services’ definition for vaccinations in CPCF

Could long Covid’s signs of immune dysregulation in the blood lead to a diagnostic test?

Why MAHA wants whole milk back on the table

STAT+: Tracking the FDA advisory panel on MDMA therapy for PTSD

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

Obesity drugs’ next tests, and rising threats: 3 chronic disease stories to watch

STAT+: A PBM in Africa flips the industry’s script in a bid to make people healthier

STAT+: It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials

Opinion: Fixing U.S. public health will require a health-systems revolution — and for physicians to take a backseat

STAT+: Exact Sciences reports initial positive results in colon cancer blood test, but pivot trial still pending

STAT+: With new study data, Intra-Cellular could expand use of approved mood-disorder treatment

STATUS List Spotlight: A Conversation with Otis Brawley

STAT+: Agios drug reduces blood transfusions in patients with beta-thalassemia, study shows

Opinion: Needed: a new framework to make sure health companies play fair with patient data

A letter from the executive editor: The 2023 STATUS List

Obesity needs a new definition, says global commission

Gene therapy trial shows promise for treating ‘bubble boy’ syndrome. Now comes the hard part

Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

Senators push IRS to launch nonprofit hospital probe

Roche enters into a definitive agreement to acquire Telavant including rights to novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant

Opinion: STAT+: The need for regulatory grade evidence: Are you in the stadium or the sandbox?

STAT+: Generic group sues Illinois over a price-gouging law with ‘draconian regulations’

STAT+: For this cancer-focused digital health startup, an FDA rejection meant the end of the road

Bipolar disorder: how lithium as a treatment fell out of favour

STAT+: Apellis safety probe of eye disease drug identifies injection needle as possible cause of severe side effect

STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

A biopharma doubles down on diversity goals through a newly created position

STAT+: What to know about this summer’s landmark Wegovy heart health study

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