PharmaTech

APRIL 8, 2024

Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety.

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Safety Patients 52

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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Safety Patients Healthcare Healthcare 89

Pharmaceutical Technology

NOVEMBER 20, 2024

The Phase III BROOKLYN trial saw HeFH patients randomly assigned in a 2:1 ratio to receive either obicetrapib or a placebo for 52 weeks.

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Safety Patients 52

Pharmacy Times

SEPTEMBER 26, 2024

Issues around patient safety, proper administration, and monitoring need careful consideration from pharmacists and other health care providers for vaccination efforts.

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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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Safety Patients Medical 107

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). Patients were 1.21 percent of quetiapine XR patients.

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Safety Leads Patients Pharmaceutical 109

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.

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FDA Safety Pharma Patients 309

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

Pharmacy Times

MARCH 1, 2024

Although regulation takes time, real safety concerns for patients in the rapid development of AI technology in health care are present today.

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Safety Patients 64

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.

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Safety Management Patients Healthcare 60

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.

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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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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 (..)

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Safety FDA Medicine Patients 285

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.

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Side effects FDA Safety Doctors 280

Pharmacy Times

AUGUST 11, 2023

New standards from the National Council for Prescription Drug Programs could drive changes that improve patient safety by optimizing drug therapy to reduce the risk of harm and improve health and well-being before a medication is dispensed.

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Safety Patients Prescription Medical 49

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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Safety FDA Patients Biopharma 102

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

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.

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Safety Competition Marketing Patients 223

PharmaTimes

SEPTEMBER 21, 2023

The report outlines ways the government can help patients with Parkinson’s disease - News - PharmaTimes

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Government Safety Patients 106

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.

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Patients Safety Healthcare Healthcare 60

European Pharmaceutical Review

MAY 29, 2024

The safety and tolerability of rationally-designed live bacterial product (LBP) BMC128 combined with nivolumab has shown initial positive trends in non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC), new data from an ongoing Phase I clinical trial suggests.

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Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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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.

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Pharmacy Times

JUNE 3, 2024

Asciminib demonstrated stronger efficacy, safety, and tolerability, as well as less adverse events in patients compared with those who received investigator-selected standard-of-care tyrosine kinase inhibitors.

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Safety Patients 37

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.

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Safety Patients 110

pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? Accelerating safe access.

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Safety FDA Medicine Patients 96

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.

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Safety Patients Management Healthcare 97

PharmaTimes

MAY 30, 2024

The first phase of the programme will be in place in hospitals across the UK by March 2025

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Pharmacy Times

SEPTEMBER 18, 2024

Reasons include fear of adverse effects, lack of education, polypharmacy, and others

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Safety Medical Education Patients 59

Referral MD

OCTOBER 7, 2024

Securing Patient Portals: Best Practices for Protecting Online Records 33.33% of patient portals have privacy concerns that create a sense of distrust among many providers and patients. Implement 1-2 strategies below to better comply with privacy regulations and protect your patients against breaches.

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Fierce Pharma

JULY 31, 2024

Three-year data from a study of early Alzheimer’s disease (AD) patients on Eisai and Biogen’s Leqembi showed that longer-term use provi | Three-year data from a study of early Alzheimer’s disease patients on Eisai and Biogen’s Leqembi showed that longer-term use provides continued benefits without additional safety concerns.

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Safety Patients 273

Pharmacy Times

APRIL 24, 2024

Carefully checking every piece of information and proofreading for accuracy is crucial to ensure patient safety

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Safety Medical Patients 52

Pharmacy Times

FEBRUARY 15, 2024

Experts discuss advantages of prefilled syringes in opioid delivery—reducing errors, enhancing safety, and minimizing waste—while providing insights on optimizing dosage forms.

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Safety Patients 26

PharmaTech

JULY 5, 2022

To ensure patient safety, drug products must be tested for elemental impurities that pose risk.

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Safety Patients 52

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

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FDA Patients Safety Biopharma 104

Pharmacy Times

OCTOBER 23, 2024

Pharmacists can educate patients about how to recognize unsafe online sources of medications and ensure patients are properly educate on how to administer their medications.

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Medical Safety Education Patients 64

European Pharmaceutical Review

MAY 20, 2024

3 Significant unmet needs The path to diagnosis of a rare disease is complex, taking on average five to eight years from the onset of symptoms before a patient receives an accurate diagnosis. Even with a diagnosis, patients continue to face barriers to care. Engaging with patients and caregivers is key to addressing these challenges.

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