PharmExec

OCTOBER 4, 2022

October 4th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Managing drug, vaccine, and device safety has become increasingly challenging as companies are confronted with adverse event (AE) caseloads rising as much as 30-50% per year.

Safety 52

Safety Management 52

Pharmacy Times

FEBRUARY 7, 2024

The 23-valent pneumococcal polysaccharide vaccine was most likely associated with a higher risk of immunological events for those who were immunocompromised, but the events were low.

Safety 55

Safety 55

PM360

NOVEMBER 27, 2023

Up to now, drug safety teams have relied primarily on reactive reporting systems for pharmacovigilance (PV) or real-world drug safety monitoring. Most traditional signal detection methods focus on disproportionality, meanwhile calling attention to higher-than-expected correlations between the suspect drug and an adverse event (AE).

Safety 106

Safety Electronics Patients Physicians 106

Pharmacy Times

APRIL 8, 2024

Investigators reported a low incidence of adverse events after simultaneous vaccination against seasonal influenza and respiratory syncytial virus.

Safety 55

Safety Patients 55

Clarivate

OCTOBER 10, 2022

As part of the Drugs to Watch program, Clarivate experts use proprietary data sources, landscape and event monitoring and deep market knowledge to identify key drug developments expected to have a significant impact on patients and markets. 8] Median PFS (secondary endpoint) also significantly improved with fruquintinib versus control (3.7

Marketing 52

Marketing Safety Patients Competition 52

European Pharmaceutical Review

APRIL 5, 2024

A 70 percent reduction in the risk of metabolic decompensation events was reported by eight participants in the 12-month pretreatment period, according to the trial results published in Nature. Study data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

Side effects 90

Side effects Safety Patients Leads 90

Pharmacy Times

MARCH 15, 2024

The pneumococcal vaccine was most likely associated with a higher risk of immunological events for those who were immunocompromised

Safety 37

Safety Medical 37

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 106

Healthcare Healthcare Safety Patients 106

European Pharmaceutical Review

NOVEMBER 17, 2023

UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome, data from the clinical trial found. “… previously we have not had adequate data for treatment options during this earliest phase,” stated Dr Peter Goadsby, PhD, neurologist and professor at King’s College London.

Medicine 75

Medicine Safety Patients Pharmaceutical 75

Pharma Marketing Network

SEPTEMBER 15, 2021

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. The post EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual appeared first on Pharma Marketing Network. REGISTER TODAY.

Safety 52

Safety Medical Digital Media Marketing 52

European Pharmaceutical Review

MARCH 6, 2024

Keren Haruvi, President Sandoz North America highlighted that denosumab is a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events. The approval is also accompanied by labelling with safety warnings. Wyost Similarly, Wyost 120 mg/1.7

Food and Drug Administration 91

Food and Drug Administration Medicine FDA Food 91

Pharmacy Times

FEBRUARY 13, 2024

The results indicate promising rates of complete response, manageable adverse events, and dose-dependent exposure in both dose groups.

Safety 26

Safety Patients Management 26

European Pharmaceutical Review

OCTOBER 18, 2022

The ZUMA-7 study demonstrated that treated patients had a four-fold greater improvement in the primary endpoint of event-free survival over the current SOC (8.3 The trial had a safety profile that was consistent with previous studies. Among the 170 axicabtagene ciloleucel-treated patients evaluable for safety, Grade ?3

Side effects 102

Side effects Safety Patients Medical 102

Pharmaceutical Technology

AUGUST 8, 2022

The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

OCTOBER 21, 2022

The safety profile observed in the extension study was consistent with safety data for the vaccine. The incidence of serious adverse events was consistent with the age of the study population. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were observed.

Safety 89

Safety Patients Pharmaceutical Marketing 89

Pharmaceutical Technology

OCTOBER 4, 2022

This event is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity. With respect to its safety profile, adverse events ranged from mild to moderate among subjects, and treatment discontinuation due to adverse events was 6.2%

Safety 105

Safety Patients Marketing Pharmaceutical 105

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 116

Patients Leads Healthcare Healthcare 116

European Pharmaceutical Review

DECEMBER 14, 2022

The primary endpoint for the study is recurrence-free survival, and secondary endpoints include distant metastasis-free survival and safety. Safety data from the Phase IIb trial assessing an mRNA cancer vaccine plus KEYTRUDA ®. The safety profile of KEYTRUDA ® was consistent with that observed in previously reported studies.

Safety 109

Safety Patients Medical Pharmaceutical 109

European Pharmaceutical Review

MARCH 13, 2024

While safety results were consistent with previously reported data (FRONTIER 1), across JNJ-2113 treatment groups, 58.6 percent of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders, J&J noted. at 16 weeks and 76.2

Safety 81

Safety Patients Pharmaceutical 81

European Pharmaceutical Review

MARCH 26, 2024

Additionally, mRNA-1283 was found to have a similar safety profile to Moderna’s approved vaccines for COVID-19. In the Phase III clinical trial , the most common solicited adverse events included injection site pain (local) and headache, fatigue, myalgia and chills (systematic), Moderna confirmed.

Safety 92

Safety Leads Patients Pharmaceutical 92

PharmExec

JULY 29, 2022

The use of biometric data and novel digital biomarkers in the administration of CAT-T therapy can both improve the safety profile and reduce patient burden of cancer treatment.

Safety 59

Safety Patients 59

European Pharmaceutical Review

OCTOBER 13, 2022

The SKYLIGHT 4 trial results demonstrate the 52-week safety and tolerability of fezolinetant 30mg and 45mg administered once daily. SKYLIGHT 4 is a 52-week double-blinded, placebo-controlled study, designed to investigate the long-term safety of fezolinetant. Senior Vice President and Head of Development Therapeutic Areas, Astellas.

Safety 90

Safety Medicine Pharmaceutical Marketing 90

European Pharmaceutical Review

NOVEMBER 7, 2022

The designation is based on six months of follow-up data from a Phase II study ( NCT04649359 ) evaluating the safety and efficacy of a 76mg weekly (QW) dose of elranatamab, which showed overall response rate (ORR) was 61 percent. . The investigation noted elranatamab delivered a manageable safety profile. Pfizer Inc.

Food and Drug Administration 96

Food and Drug Administration Medicine Safety FDA 96

European Pharmaceutical Review

MARCH 8, 2024

As for its benefits in pharmacovigilance, the paper explained that GAMP 5 “helps organisations maintain high-quality standards in adverse event reporting and analysis, ensuring the safety of patients and the integrity of data. Quality by design supports the move towards Pharma 4.0,

Pharmaceutical 85

Pharmaceutical Pharma Safety Manufacturing 85

Pharmacy Times

MAY 15, 2023

Treatment-emergent adverse events were reported in a similar proportion of participants with recurrent Clostridioides difficile infection, both with and without immunocompromising conditions.

Safety 26

Safety Patients 26

pharmaphorum

AUGUST 30, 2022

Asundexian fulfilled its promise on safety in both PACIFIC studies, with “consistent safety results for asundexian comparable to placebo arm,” regardless of background antiplatelet therapy, and without an increase in bleeding. On safety, the incidence of major bleeding was low and similar to placebo.

Safety 80

Safety Side effects Patients 80

European Pharmaceutical Review

NOVEMBER 17, 2023

Lebrikizumab represents a “significant step forward” in patients with moderate-to-severe atopic dermatitis not controlled with topical therapy due to its selective mechanism of action, proven short and long-term efficacy and safety and a monthly maintenance dosing for all patients. EC approval was based on three pivotal Phase III studies.

Safety 83

Safety Patients Management Leads 83

European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. Essentially, the risk-based framework pushes developers of medical devices to emphasise high-risk issues, like ones that impact product quality, instead of all events.

Food and Drug Administration 52

Food and Drug Administration Medical Management FDA 52

European Pharmaceutical Review

JUNE 6, 2023

The safety and tolerability of TAGRISSO with extended follow-up were consistent with its established profile and previous analyses with no new safety concerns reported. Adverse events at Grade 3 or higher from all causes occurred in 23 percent of patients in the TAGRISSO arm versus 14 percent in the placebo arm.

Safety 93

Safety Patients Pharmaceutical 93

European Pharmaceutical Review

JUNE 15, 2023

However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. This microbial contamination can lead to a range of adverse events, such as infections, adverse reactions, or device failures, which can compromise patient safety and health outcomes.

Manufacturing 82

Manufacturing Medical Safety Transportation 82

pharmaphorum

SEPTEMBER 26, 2022

As the field strives to strike a delicate balance between safety and efficacy, in the context of increased regulatory scrutiny and safety challenges, attending the 4 th Annual Gene Therapy Analytical Development as an analytical scientist has never been so important. Download the full event guide to find out more.

Safety 52

Safety Pharma 52

Pharmacy Times

NOVEMBER 22, 2023

Lisa Schrade, PharmD, and Robert Sidonio Jr, MD, MSc, discuss real-world evidence for hemophilia A therapies, highlighting their safety, efficacy, and impact on bleeding events, nurse visits, and hospital visits.

Safety 26

Safety 26

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve.

Safety 113

Safety Medicine Competition Networking 113

pharmaphorum

AUGUST 16, 2022

Dosing considerations dependent on your disease indication, route of administration and patient group for improved safety. Hear the latest insights and case studies to optimize your prediction of PKPD, accurate dosing regime and immuno-modulation of LNP for long-term patient safety and potency. And much more!

Pharmacology 52

Pharmacology Safety Networking Patients 52

Pharmaceutical Technology

APRIL 21, 2023

Nonetheless, the agency did not require further efficacy and safety data in the application. The drug’s safety was generally manageable, and the rates of Grade 3 and higher treatment-emergent adverse events (TEAEs) were similar. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

Pharma Marketing Network

JULY 3, 2021

Tracks at this year’s event include: marketing, cross-disciplinary & innovation, community & public relations, strategic planning & business development, digital engagement, and leadership. Attendees at the in-person event this September automatically receive access to the virtual conference in October. Register Today!

Networking 52

Networking Safety Education Marketing 52

Pharmaceutical Technology

JULY 27, 2022

Headache, fall, back pain, procedural pain and pain in extremities were the most frequent adverse events (AEs) reported in subjects who received tofersen in VALOR and the OLE study. of subjects who received tofersen in VALOR and OLE studies had serious neurologic events including myelitis, aseptic meningitis, radiculitis and papilledema.

Food and Drug Administration 98

Food and Drug Administration FDA Food Safety 98