MedCity News

OCTOBER 1, 2024

CMS recently finalized the Patient Safety Structural Measure, which sets forth a broad roadmap for the implementation of a culture of safety, learning, transparency and accountability within hospitals and health systems nationwide — enabling and encouraging significant progress towards safer care and improved support for healthcare workers.

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MedCity News

JUNE 14, 2024

The post From Recalls to Reliability: Tools to Ensure Software Safety in MedTech appeared first on MedCity News. Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

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MedCity News

MAY 27, 2024

The post The Value-based Care Throughline to Healthcare Quality and Safety appeared first on MedCity News. By prioritizing continuous patient engagement and strategic communication across the entire care journey, healthcare organizations can drive real progress toward value-based care.

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MedCity News

APRIL 15, 2024

The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News. The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia.

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MedCity News

SEPTEMBER 7, 2023

The President’s Council of Advisors on Science and Technology (PCAST) issued a report that laid out four recommendations to improve patient safety across the nation. Some of these included creating federal leadership positions focused on advancing patient safety and hastening research on systems of safe care.

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MedCity News

APRIL 24, 2023

A shift from fee-for-service payment models to value-based models is not an effective way to address the severe financial pressures that safety net hospitals are facing, experts argued at the HIMSS conference in Chicago. One called for a paradigmatic shift “away from cost savings and toward understanding where investments are needed.”

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MedCity News

JULY 26, 2024

The post EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks appeared first on MedCity News. The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi.

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Fierce Pharma

JANUARY 17, 2023

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

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MedCity News

NOVEMBER 10, 2024

While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia.

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MedCity News

FEBRUARY 21, 2024

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

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MedCity News

JULY 7, 2024

In addition to making suicide screening more accessible and widespread, successful implementation of safety plans is critical — here are 3 recommendations that care teams can implement. The post Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them? appeared first on MedCity News.

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MedCity News

MARCH 9, 2025

While initial adoption is focused mainly on non-clinical areas like scheduling and prior authorizations, experts predict that AI agents could eventually play a role in clinical decision-making, provided they meet rigorous safety and reliability standards.

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Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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MedCity News

FEBRUARY 26, 2023

Creating a category for technologies like the safety release valve would confer benefits, including improved patient safety, reduced costs for the healthcare system overall, and lowered liability risk.

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MedCity News

JANUARY 31, 2025

The post MedCity Pivot Podcast: Embedding a New Data Safety Standard in Healthcare appeared first on MedCity News. We kick off our first season of the MedCity Pivot Podcast by discussing ways healthcare organizations can protect themselves from being targets of a cybersecurity attack. A new IEEE Standard can help.

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MedCity News

NOVEMBER 12, 2024

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

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Fierce Pharma

NOVEMBER 1, 2024

Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D., . | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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MedCity News

DECEMBER 2, 2024

Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study.

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MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

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MedCity News

JULY 6, 2023

While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks. Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval.

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MedCity News

MARCH 13, 2023

Each year, nonprofit ECRI creates a list of the industry’s top ten patient safety concerns. This year, the pediatric mental health crisis topped the list, above other important issues like violence against healthcare staff and clinicians being expected to work outside their scope of practice.

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MedCity News

JUNE 22, 2022

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity. .

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MedCity News

JANUARY 24, 2025

The program has been going on for a little more than a year and Amy Rosa, the health systems chief nursing informatics officer, says the initiative is already resulting in increased efficiency, documentation accuracy and patient safety. The post Why Sentara Health Invested $11M Into iPhones for Nurses appeared first on MedCity News.

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MedCity News

JULY 13, 2022

When thinking about gratitude for nurses who have carried our nation over the last two-plus years, it’s going to take a lot more than a pizza party during Nurses Month to show them we care.

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Fierce Pharma

MAY 17, 2023

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

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MedCity News

NOVEMBER 4, 2024

Higher doses of a Viking Therapeutics pill that targets two receptors led to greater weight loss without worsening safety or tolerability, according to Phase 1 results presented during the ObesityWeek conference. Meanwhile, an injectable version of this Viking drug is on track to Phase 3 testing.

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Fierce Pharma

JANUARY 24, 2024

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

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Fierce Pharma

AUGUST 20, 2024

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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MedCity News

JUNE 11, 2023

Human tissues, coupled with AI that can deal with terabytes of data will blow mice models out of the water. With animal testing requirements finally removed, the pharma industry and its constituents can hope for faster innovation.

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MedCity News

JANUARY 13, 2023

There’s been a recent wave of nurse strikes, but Theresa Brown — a nurse and New York Times bestselling author — said she’s never met a nurse that happily embraces striking. Nurses only strike when it’s the only option left to protect patients and deliver quality care, she declared.

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PharmaVoice

AUGUST 13, 2024

Immunic’s treatment has anti-inflammation, neuroprotection and antiviral effects plus a ‘benign’ safety profile that even seems to lower the risk of COVID-19 infection.

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Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

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Fierce Pharma

APRIL 19, 2024

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

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MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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MedCity News

DECEMBER 6, 2024

Leaders across healthcare, technology, and policy circles agree that cybersecurity isn’t just a technical necessity it’s foundational to patient safety The post Stronger Cybersecurity in Healthcare Starts with Smart Policy appeared first on MedCity News.

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