Patients and Safety - Pharma Rep Focus

Pharma Must Speak Up for Patient Safety

World of DTC Marketing

JUNE 21, 2025

It’s a basic principle: the healthcare system exists to serve patients. Yet, astonishingly, the very institutions tasked with protecting and managing our healthcare can sometimes become a threat to patient safety. Patient safety and advocacy must take precedence over fears of political or regulatory retribution.

Safety

Safety Pharma Patients Government

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

MedCity News

APRIL 14, 2025

Pfizer said a patient dosed with danuglipron developed potential drug-induced liver injury. Pfizer is stopping further work on this program, a move that comes nearly two years after it discontinued development of a different obesity drug due to liver safety signals in a clinical trial.

Safety

Safety Patients Biopharma Pharma

Connected Care, Shared Goals: Designing Whole-Person Care for Complex Patient Populations

MedCity News

MAY 18, 2025

As the safety-net landscape shifts and funding uncertainty grows, the path forward is clear. The post Connected Care, Shared Goals: Designing Whole-Person Care for Complex Patient Populations appeared first on MedCity News.

Patients

Patients Safety

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

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.

Safety

Safety Patients Healthcare Healthcare

How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | said in an interview with Fierce Pharma.

FDA

FDA Safety Pharma Patients

No Wrong Door: How Policy, Technology & Partnerships Can Power a Connected Social Safety Net

MedCity News

JUNE 29, 2025

Through the convergence of proactive policy, advanced technology and strategic public-private partnerships, we can achieve this “no wrong door” vision and deliver a connected, streamlined social safety net that’s more efficient, economical, and effective. Here’s how.

Safety

Safety Physicians Patients

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

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.

Safety

Safety Patients Healthcare Healthcare

Staff Safety is Key to Sustaining Home Health Growth

MedCity News

OCTOBER 1, 2024

Innovative approaches to home care will only be successful if organizations can ensure the safety of the professionals who enter patient homes. The post Staff Safety is Key to Sustaining Home Health Growth appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

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.

Safety

Safety Patients Biopharma

Medication Management Technology Puts Patient Safety at the Center of Care

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.

Safety

Safety Management Medical Patients

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

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.

Safety

Safety Patients Healthcare Healthcare

The Value-based Care Throughline to Healthcare Quality and Safety

MedCity News

MAY 27, 2024

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

Safety

Safety Healthcare Healthcare Patients

Why Sentara Health Invested $11M Into iPhones for Nurses

MedCity News

JANUARY 24, 2025

Sentara Health invested $11 million into smartphones for its nurses, equipping them with HIPAA-compliant devices to streamline communication, increase time at the bedside and improve patient outcomes. The post Why Sentara Health Invested $11M Into iPhones for Nurses appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

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.

Safety

Safety Patients Medical

Why We Need a New Category for Safety Devices

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.

Safety

Safety Healthcare Healthcare Patients

Sometimes Striking Is the Only Way Nurses Can Protect Patient Safety, Expert Says

MedCity News

JANUARY 13, 2023

Nurses only strike when it’s the only option left to protect patients and deliver quality care, she declared. 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.

Safety

Safety Patients

FDA Just Made Some Key Regulatory Changes to Make Cancer Cell Therapies More Accessible

MedCity News

JUNE 27, 2025

The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial analysts say the changes should improve patient access to these personalized cancer treatments.

FDA

FDA Safety Marketing Patients

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

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.

Safety

Safety FDA Patients Biopharma

6 Questions To Ask Before Integrating AI Into A Clinical Workflow

MedCity News

JUNE 16, 2025

As the adoption of artificial intelligence (AI) advances in healthcare, key considerations can help validate that the technology is purpose-built to help clinicians protect patient safety. The post 6 Questions To Ask Before Integrating AI Into A Clinical Workflow appeared first on MedCity News.

Safety

Safety Healthcare Healthcare Patients

Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say

MedCity News

OCTOBER 6, 2024

Hospitals are facing increasingly burdensome policies from commercial insurers, leading to problems with cash flow and patient safety. The post Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say appeared first on MedCity News.

Patients

Patients Insurance Safety Leads

AbbVie Pays $700M for Drug Engineered to Overcome Resistance in Multiple Myeloma

MedCity News

JULY 10, 2025

Early Phase 1 results showed encouraging responses in a heavily pretreated patient population and a favorable safety profile. AbbVie has acquired rights to a multispecific antibody that IGI Therapeutics designed to bind to three targets to treat multiple myeloma.

Engineering

Engineering Safety Patients Biopharma

Nursing & Patient Safety – Using Malpractice Claims to Identify Risk Trends [Sponsored]

MedCity News

JULY 26, 2022

Nurses face challenges that put themselves and their patients at risk. Using closed claim data, Coverys identified nursing risk trends. A full report, including recommendations, will be released this year.

Safety

Safety Patients Management Healthcare

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

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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Safety Medical Education FDA

Why Biosimilars Struggle Despite FDA Approval

World of DTC Marketing

JULY 6, 2025

The Power of Entrenched Brand Loyalty Biologic manufacturers have spent years, sometimes decades, building trust with physicians and patients. Even when a biosimilar is deemed equally effective and safe, prescribers may hesitate to switch a stable patient. These brands are often seen as the gold standard.

FDA

FDA Physicians Manufacturing Insurance

The Hidden Cost of Disconnected Quality Systems: Why Hospitals Should Modernize Now

MedCity News

JUNE 6, 2025

It’s about equipping hospitals with the resources necessary to manage risk proactively, respond to negative trends quickly, and prioritize patient safety with high reliability. The case for modernization isn’t solely about improving efficiency.

Safety

Safety Management Patients Physicians

Aggregate Data to Improve Patient Safety: How Data Can Inform Risk Management [Sponsored]

MedCity News

APRIL 3, 2023

Data can help healthcare facilities improve patient safety, but first, healthcare leaders need to bring data from multiple sources together using a common taxonomy.

Safety

Safety Management Patients Healthcare

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

MedCity News

APRIL 11, 2023

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

Management

Management Safety Patients Pharmaceutical

Stronger Cybersecurity in Healthcare Starts with Smart Policy

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.

Healthcare

Healthcare Healthcare Safety Patients

Correcting Provider Biases About Transgender and Gender Non-Conforming Patients Can Protect Their Health and Safety

MedCity News

SEPTEMBER 22, 2023

Providers, administrators, health insurers and other healthcare-access gatekeepers can learn, train, change policies and remove barriers facing vulnerable groups so they can receive the long-overdue opportunity to pursue their best health and well-being.

Safety

Safety Insurance Training Healthcare

Do patients care about accelerated approval drugs?

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

Patients

Patients FDA Doctors Physicians

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

Safety

Safety FDA Medicine Patients

From Public to Private: Do Laid-Off FDA and CDC Employees Have the Skills Pharma and Biotech Need?

World of DTC Marketing

JUNE 6, 2025

Deep Regulatory Expertise FDA and CDC employees are steeped in the complexities of public health regulation, drug and device approval pathways, and safety monitoring. Their grounding in data-driven decision-making, peer-reviewed research, and public health ethics adds credibility to any medical affairs, safety, or regulatory team.

Pharma

Pharma FDA Ethics Government

Private Equity Ownership Leads to Worse Patient Outcomes at Hospitals, Study Shows

MedCity News

JANUARY 2, 2024

Yet another study has been published showing that patients receiving care at PE-owned hospitals experienced a higher rate of hospital-acquired adverse events, like infections and falls, than patients receiving care at hospitals that are not PE-owned.

Patients

Patients Leads Healthcare Healthcare

Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

MedCity News

OCTOBER 16, 2023

Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly, to patients. Lungs hyperinflated to clear. No pneumothorax or pleural eltusion.

Healthcare

Healthcare Healthcare Patients Doctors

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

DECEMBER 9, 2023

BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. | A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions.

Side effects

Side effects FDA Safety Doctors

Incyte's Opzelura clears skin in children with atopic dermatitis, but safety remains a question

Fierce Pharma

JULY 12, 2023

Fighting for a place in the competitive atopic dermatitis market, Incyte hopes to reach younger patients with its JAK inhibitor cream Opzelura. Fighting for a place in the competitive atopic dermatitis market, Incyte hopes to reach young patients with its JAK inhibitor cream Opzelura.

Safety

Safety Competition Marketing Patients

Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products

MedCity News

AUGUST 2, 2024

While the approach to patient and treatment safety is crucial, there is a notable shift towards processes centered around patients and healthcare professionals. Many medtech products, very often too technical and scientific, emphasize features at the expense of processes and their interactions.

Engineering

Engineering Medical Safety Healthcare

The One Conversation Missing from ASCO: The Crushing Cost of Cancer Drugs

World of DTC Marketing

MAY 31, 2025

Each year, the American Society of Clinical Oncology (ASCO) meeting brings together the brightest minds in cancer research, pharmaceuticals, and patient care to share breakthroughs, data, and hope. Patients face bills for infusions, imaging, hospital stays, genetic testing, and supportive therapies—all of which add up fast.

Insurance

Insurance Patients Doctors Medical

Patients Everywhere Deserve Safer Care – Here’s How We Get There

MedCity News

AUGUST 29, 2024

Healthcare organizations tend to view issues in pockets – how they are impacting their specific organization and region – but patient safety is a collective mission. No matter what hospital or health system they are in, or which care model they belong to, patients everywhere deserve safer care.

Patients

Patients Safety Healthcare Healthcare

Overcoming the Challenges of Integrating AI in Care Management

MedCity News

AUGUST 30, 2024

Providers should carefully evaluate how different AI models can be strategically integrated to optimize the care management lifecycle and address the complex needs of their patients and populations, while at the same time prioritizing patient safety and ethical considerations.

Management

Management Ethics Safety Patients

The future of healthcare: Digitally streamlined workflows

MedCity News

AUGUST 11, 2022

The shift to digitally streamlined workflows is long overdue, and organizations that fall behind risk higher costs, lower patient satisfaction, and higher staff member burnout and put the facility at risk for a patient safety event.

Healthcare

Healthcare Healthcare Safety Patients

The Rise of Plant-Based Self-Medication and What Healthcare Must Do Next

MedCity News

APRIL 17, 2025

On the other, it raises alarms about safety, oversight, and the risk of delayed care. The self-medicating plant movement sits at the intersection of empowerment and misinformation. On one hand, it signals a growing desire for agency in personal health.

Medical

Medical Healthcare Healthcare Safety

Lack of Autonomy Is a Major Reason Clinicians Are Exiting the Field

MedCity News

OCTOBER 22, 2023

Patient safety and lack of autonomy are two of the biggest factors driving so many clinicians away from the medical field, according to a new EY report.

Safety

Safety Medical Patients

Pharma Must Speak Up for Patient Safety

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

Trending Sources

Connected Care, Shared Goals: Designing Whole-Person Care for Complex Patient Populations

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

How Machine Learning Drives Clinical Trial Efficiency

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

No Wrong Door: How Policy, Technology & Partnerships Can Power a Connected Social Safety Net

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

Staff Safety is Key to Sustaining Home Health Growth

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

Medication Management Technology Puts Patient Safety at the Center of Care

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

The Value-based Care Throughline to Healthcare Quality and Safety

Why Sentara Health Invested $11M Into iPhones for Nurses

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

Why We Need a New Category for Safety Devices

Sometimes Striking Is the Only Way Nurses Can Protect Patient Safety, Expert Says

FDA Just Made Some Key Regulatory Changes to Make Cancer Cell Therapies More Accessible

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

6 Questions To Ask Before Integrating AI Into A Clinical Workflow

Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say

AbbVie Pays $700M for Drug Engineered to Overcome Resistance in Multiple Myeloma

Nursing & Patient Safety – Using Malpractice Claims to Identify Risk Trends [Sponsored]

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

Why Biosimilars Struggle Despite FDA Approval

The Hidden Cost of Disconnected Quality Systems: Why Hospitals Should Modernize Now

Aggregate Data to Improve Patient Safety: How Data Can Inform Risk Management [Sponsored]

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

Stronger Cybersecurity in Healthcare Starts with Smart Policy

Correcting Provider Biases About Transgender and Gender Non-Conforming Patients Can Protect Their Health and Safety

Do patients care about accelerated approval drugs?

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

From Public to Private: Do Laid-Off FDA and CDC Employees Have the Skills Pharma and Biotech Need?

Private Equity Ownership Leads to Worse Patient Outcomes at Hospitals, Study Shows

Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Incyte's Opzelura clears skin in children with atopic dermatitis, but safety remains a question

Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products

The One Conversation Missing from ASCO: The Crushing Cost of Cancer Drugs

Patients Everywhere Deserve Safer Care – Here’s How We Get There

Overcoming the Challenges of Integrating AI in Care Management

The future of healthcare: Digitally streamlined workflows

The Rise of Plant-Based Self-Medication and What Healthcare Must Do Next

Lack of Autonomy Is a Major Reason Clinicians Are Exiting the Field

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