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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Safety FDA 272

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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Safety 144

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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Safety 326

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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Safety FDA 278

MedCity News

MAY 14, 2024

The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News. Healthcare devices must be exempted from general right to repair legislation.

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Safety Healthcare Healthcare 122

Scott Burrows

MAY 2, 2023

It is Time to Get Accountable about Safety As a motivational safety team speaker, I am familiar with the many recent studies on isolation and loneliness. If you’re currently scratching your head as to what loneliness might have to do with safety, just stay with me for a moment as we move through…

Safety 98

Safety 98

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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Safety 351

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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Safety Patients Medical 108

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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Safety Healthcare Healthcare Patients 116

Scott Burrows

JULY 19, 2022

The 7 Safety Myths As a motivational workplace safety speaker, let me pitch a serious question: Who are You Keeping Safe? It’s a proven fact that when we look out for one another, everyone in the workplace is safer. While the accepted wisdom used to be “I look out for me, because I…

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Safety 98

pharmaphorum

MAY 1, 2024

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

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Safety Marketing Pharma 104

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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Safety Medicine Biopharma Pharma 106

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

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Safety Food and Drug Administration Prospecting Food 98

Pharmaceutical Technology

AUGUST 13, 2024

The incorporation of cognition into the safety profiles of both CNS and non-CNS indications is becoming increasingly critical.

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Safety Competition 52

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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Safety Management Medical Patients 108

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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Safety FDA Leads Biopharma 110

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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Safety Patients Healthcare Healthcare 105

European Pharmaceutical Review

SEPTEMBER 26, 2023

In this method, Individual Case Safety Reports (ICSRs) are manually entered into the target database using outputs obtained from the source database. The list of non-transferable safety case data is fairly normalised for both E2B(R2) and E2B(R3) formats.

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Safety Pharma Pharmaceutical Electronics 105

PharmaTech

JUNE 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

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Safety 76

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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Safety 91

European Pharmaceutical Review

MARCH 27, 2024

However, due to the importance of pyrogen testing for the safety of pharmaceutical products , the report stated that this will help to drive market growth. Researchers propose novel test for pyrogen detection The post Drug safety driving pyrogen testing market expansion appeared first on European Pharmaceutical Review.

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Safety Marketing Food and Drug Administration Pharmaceutical 94

European Pharmaceutical Review

OCTOBER 10, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD).

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Safety Leads Patients Pharmaceutical 109

PharmaTech

FEBRUARY 21, 2024

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

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Safety FDA 52

Scott Burrows

JANUARY 17, 2023

“Safety Affects Everyone in the 2023 Workplace – Including You” There has been an important shift in workplace safety that will involve everyone in your organization. As a motivational safety speaker, I must emphasize that “safety” is more critical than ever. Forget the posters and harnesses?

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Safety 52

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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Safety 96

Veeva

APRIL 22, 2024

A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.

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Safety Management Biopharma Patients 52

Pharmaceutical Technology

NOVEMBER 1, 2022

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. It also includes projects and initiatives by companies to improve health and safety in other public environments other than their own workspaces.

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Safety Media Pharmaceutical Marketing 52

Pharmaceutical Technology

SEPTEMBER 23, 2024

New safety data shows an absence of post-injection syndrome, a rare and serious side effect of long-acting olanzapine.

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Safety Side effects 52

Scott Burrows

MARCH 22, 2023

Caring About Safety Has Never Been More Important How safe do you feel on your job? As a workforce safety speaker who once suffered a tragic workplace related accident, I ask you to think carefully before answering. Often, the lack of safety training affects both clients and customers.

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Safety Training Transportation Food 52

PM360

NOVEMBER 9, 2023

Award-winning health and wellness advertising agency AbelsonTaylor Group received the inaugural ACE Aspire Award for its employee Psychological Safety Initiative from the Healthcare Businesswomen’s Association (HBA). In 2022, AbelsonTaylor developed and implemented a large-scale, ongoing Psychological Safety initiative for its 300 employees.

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Safety Healthcare Healthcare Recruitment 111

Scott Burrows

OCTOBER 25, 2022

What’s New in Safety? You might not want to know) As a motivational safety speaker, I must admit that I am obsessed with safety. I myself became a safety statistic after leaving a job site. So, keynote speaking on safety isn’t a “lazy exercise” for me. It is intensely personal and I live…

Safety 52

Safety 52

Scott Burrows

MARCH 22, 2023

Caring About Safety Has Never Been More Important How safe do you feel on your job? As a workforce safety speaker who once suffered a tragic workplace related accident, I ask you to think carefully before answering. The data for 2022 were not encouraging in terms of improvement. Workforces are still experiencing more…

Safety 52

Safety 52

Scott Burrows

MAY 2, 2023

It is Time to Get Accountable about Safety As a motivational safety team speaker , I am familiar with the many recent studies on isolation and loneliness. What this means for safety Workplace safety can only thrive in an environment of teamwork, where every member of the team, top to bottom, is accountable and engaged.

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Safety Manufacturing Healthcare Healthcare 52

Scott Burrows

AUGUST 9, 2024

About 6 months ago, I had the privilege of delivering a presentation on Business, Leadership, and Safety to leaders and supervisors at the Elevator Contractors Association Annual Meeting. With Grit , you must take the necessary steps to ensure success and safety. The crowd was amazing, everyone was so lively and willing to learn.

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Safety Management Leads 52

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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Safety Healthcare Healthcare Patients 96