STAT

FEBRUARY 5, 2024

Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

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STAT

DECEMBER 19, 2023

Amy Abernethy, the president of product development and chief medical officer at Verily, a health care spinout of search giant Alphabet, will leave the company at the end of the first quarter to start a nonprofit aimed at changing the way the health care system collects data. Continue to STAT+ to read the full story…

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STAT

FEBRUARY 1, 2024

Bluebird and the case for gene therapy profits Genetic treatments that are potential cures for inherited diseases are a huge medical advance, but can these transformational (and expensive) products become a profitable business? The other products are Zynteglo for beta thalassemia ($2.8 million), Bluebird sells three gene therapies.

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STAT

NOVEMBER 28, 2023

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement.

Hospitals 363

Hospitals 363

STAT

AUGUST 7, 2023

There are many period products on the market from pads, tampons and cups to discs. Heavy menstrual bleeding affects up to a third of people who menstruate and that can only be diagnosed using traditional menstrual products like pads and tampons. Read the rest…

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STAT

MARCH 18, 2024

Investors are starting to back startups that offer privacy and security services to bolster health AI products already on the market while they wait for crucial safety and privacy regulations to take shape.

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Hospitals 286

STAT

SEPTEMBER 5, 2023

Microsoft has formed an alliance with the electronic health records vendor Epic to wire the technology into dozens of health software products. Google is infusing it into tools used by hospitals to collect and organize data on millions of patients. Continue to STAT+ to read the full story…

Hospitals 337

Hospitals 337

STAT

JANUARY 30, 2024

The company plans to officially launch the product at this year’s Advances in Genome Biology and Technology meeting, which kicks off in Orlando, Fla., Continue to STAT+ to read the full story…

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APRIL 1, 2024

We hope your day is meaningful and productive. Harvard Business School professor Francesca Gino sued Data Colada following their public allegations of research misconduct against her — a move data manipulation researchers said has had a chilling effect on the field , The Harvard Crimson says. Feel free to look it up.

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STAT

NOVEMBER 17, 2023

Gathering health data remotely is a pain. A team of researchers has tested Celero’s device in humans for the first time, successfully capturing heart and respiratory data in 10 patients with sleep apnea. Forgetting to slip on a wearable is easy, and hooking yourself up to a large monitor is intrusive.

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STAT

MAY 13, 2024

 For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry. Continue to STAT+ to read the full story…

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Diabetes 182

STAT

MAY 18, 2023

The Vaccines and Related Biological Products Advisory Committee voted 14-0 that Pfizer’s data showed the vaccine was effective in preventing severe disease in infants born to people who were vaccinated during pregnancy.

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Vaccines Immunity Immunization 245

Pharmaceutical Commerce

AUGUST 31, 2023

In this breakout session, industry leaders discuss understanding and overcoming errors brought on by data challenges.

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STAT

SEPTEMBER 5, 2023

Health care leaders and technology companies are investing heavily in large language models, a powerful class of deep learning models that are trained on vast troves of data. But while enthusiasm for generative AI is high and research is booming, it’s just starting to gain a toehold in clinical settings.

Hospitals 355

Hospitals 355

FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.” Based on this data set, RWD/RWE were identified by FDA as being used in a trivial 0.34

Medical Records 111

Medical Records Documentation 111

Express Pharma

MAY 15, 2024

Packaging and labelling, being an integral part of the products, are also transforming by adopting such contemporary technologies to remain at par with the industry standards across the globe. AI is a hybrid form of programming, which is built on numerous micro-level data and various information with multiple in-built logics.

Packaging 86

Packaging Labelling 86

STAT

NOVEMBER 6, 2023

The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health care, but the companies behind these software-based tools face an uphill battle in convincing clinicians and insurers that their products can complement traditional medicine.

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OCTOBER 20, 2023

The Food and Drug Administration on Thursday released a new accounting of artificial intelligence tools cleared for use in health care, adding scores of new products designed to reshape care in several areas of medicine.

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Documentation 259

STAT

SEPTEMBER 19, 2023

In recent months, representatives of the Massachusetts state Medicaid program, MassHealth, have been presenting data suggesting reSET and reSET-O, Pear’s prescription apps that treat substance use disorder and opioid use disorder, saved the state money over a one-year period from 2021 to 2022.

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STAT

JANUARY 9, 2023

To explore how well bias is being identified in the FDA review process, we looked at virtually every health care AI product approved between 1997 and October 2022. Our audit of data submitted to the FDA to clear clinical AI products for the market reveals major flaws in how this technology is being regulated.

Labelling 248

Labelling 248

STAT

MAY 23, 2023

Health care companies are racing to incorporate generative AI tools into their product pipelines and IT systems after the technology displayed an ability to perform many tasks faster, cheaper — and sometimes better — than humans.

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Hospitals 280

STAT

MARCH 8, 2024

CooperSurgical acknowledged that the batch of fluid may have stunted embryo growth in a product recall notice , but it hasn’t disclosed exactly what went wrong. Companies will sometimes give clinics this information voluntarily, along with required labeling information like mouse embryo data, instructions for use, and warnings.

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Labelling 293

STAT

JUNE 1, 2023

Tempus, a company that combines DNA sequencing for cancer with artificial intelligence, said Thursday that it is launching a voice-and-text assistant called Tempus One that will give physicians much easier access to patient data.

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NOVEMBER 7, 2022

But the product, sold by Nuance Communications and its parent, Microsoft, comes with strings attached: To improve its accuracy, health systems sworn to protect privacy must share patients’ most sensitive data with companies trying to develop their next blockbuster product.

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Documentation Communication Hospitals 225

STAT

AUGUST 1, 2023

Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash. Plastic bags filled with torn and discarded important production records were stashed under a stairwell and on a truck parked outside. Laboratory data, in some cases, went missing.

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Chemotherapy Documentation 231

PharmaTech

NOVEMBER 27, 2023

LIGHTHOUSE Instruments introduces new technology for robust headspace data generation and areas of application.

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STAT

MAY 14, 2024

We hope that your day is meaningful and productive, and that you will keep in touch when you hear something saucy. The drugmaker presented the new long-term data on Tuesday at the European Congress on Obesity in Venice, Italy, in a new analysis from a large study for which substantial results had been published last year.

Vaccines 188

Vaccines 188

STAT

SEPTEMBER 13, 2023

Akili Interactive, which in 2020 made waves by receiving Food and Drug Administration clearance for its video game that improves symptoms of ADHD in children, on Wednesday announced it would reorient its business around selling its products directly to users over the counter, rather than by prescription. million in expenses.

Labelling 314

Labelling 314

STAT

JANUARY 18, 2024

Testmakers rapidly introduced new Covid-19 screening products with little data , as it was a brand new virus. At one point, the CDC made Stenzel wait at its facility overnight after he arrived for a meeting on Covid test development, Politico reported at the time.    It was a hectic time.

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NOVEMBER 10, 2022

States are reporting outbreak data less frequently, and globally, testing and surveillance programs have been curtailed. government will stop paying for Covid vaccines and treatments, which could widen gaps in access as the products move to being covered by insurance. Support for community vaccination campaigns has dwindled.

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Vaccines Drug Development 335

STAT

JANUARY 19, 2024

Morgan Healthcare conference, an exclusive, invitation-only event for investors, several influential health systems like Mayo Clinic and Mass General Brigham doubled down on new revenue streams including advising companies building artificial intelligence tools or licensing out custom built products as they brace for a tough 2024.

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Hospitals Mayo Clinic 285

STAT

NOVEMBER 4, 2022

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. “These data demonstrate that our BA.4/BA.5-adapted Recently BA.5

Vaccines 343

Vaccines Immunity Immunization 343

STAT

NOVEMBER 7, 2022

Californians have an opportunity on Tuesday to protect the health of their children by voting yes on Proposition 31 , which would be a vote to prohibit the sale of nearly all flavored tobacco products in the state. Although use of these products dropped during the Covid-19 pandemic, their popularity is once again starting to rise.

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MARCH 27, 2023

Novartis announced data Monday that could set up one of the biggest marketing battles in cancer. The first of these drugs, Pfizer’s Ibrance, is a $5-billion-a-year product and one of that company’s top sellers. At issue is the market for medicines called CDK 4/6 inhibitors.

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pharmaphorum

MAY 8, 2024

Could data transparency finally resolve the crisis of drug shortages? This post explores how improved data compliance practices could increase production and end chronic shortages.

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European Pharmaceutical Review

MARCH 8, 2024

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Data integrity guarantees the reliability of data collected throughout various stages of drug development.”

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Drug Development 82

LifeProNow

MARCH 20, 2023

FDA issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% The company must not market or distribute these products in the U.S. director of the FDA’s Center for Tobacco Products.

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