pharmaphorum

DECEMBER 11, 2022

Digital transformation in pharma is not a singular endeavour. It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations.

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Patients Healthcare Healthcare Medical 131

MedCity News

DECEMBER 11, 2022

Avenda Health, a startup focused on personalized prostate cancer care, recently received 510(k) clearance from the FDA for its cancer mapping platform. The platform uses a patient’s own diagnostic data to define the extent of the disease and create a cancer probability map with optimal treatment margins.

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FDA 119

Copyright Clearance Center

DECEMBER 11, 2022

The post Recipes for a Healthy Information Diet appeared first on Copyright Clearance Center.

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MedCity News

DECEMBER 11, 2022

Health benefit costs increased 3.2% in 2022, but employers are expecting costs to jump even higher in 2023, a Mercer report showed. Employers’ top priorities right now are providing benefits that attract and retain employees and boosting mental health support.

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

Pharmaceutical Technology

DECEMBER 11, 2022

Richter’s transformation (RT) is a rare blood cancer arising in up to 10% of patients with chronic lymphocytic leukemia (CLL) and presenting as aggressive lymphoma, typically as diffuse large B-cell lymphoma (DLBCL). Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials.

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FDA Patients Safety Pharmaceutical 59

MedCity News

DECEMBER 11, 2022

Johnson & Johnson is seeking FDA approval of a multiple myeloma drug that could become the first one addressing a novel target called GPRC5D. Data from the Phase 1/2 study supporting the biologics license application were presented in New Orleans during the annual meeting of the American Society of Hematology.

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FDA Biopharma Pharma 112

MedCity News

DECEMBER 11, 2022

When members have access to reliable, technology-first NEMT solutions, they are three times more likely to show up to appointments.

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Transportation Medical 103

Pharmacy Times

DECEMBER 11, 2022

Expert discusses the results of a trial assessing immune reconstitution in adult patients who received Orca-T, consisting of hematopoietic stem/progenitor cells, regulatory T cells, and conventional T cells.

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Engineering Patients 49

Pharma Leaders

DECEMBER 11, 2022

The company plans to launch a clinical study of idiopathic pulmonary fibrosis patients in 2023.

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Patients 40

Pharmacy Times

DECEMBER 11, 2022

Expert discusses clinical outcomes of the phase 3 ZUMA-7 trial assessing axicabtagene ciloleucel versus standard-of-care in second-line large B-cell lymphoma by metabolic tumor volume.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

Pharma Leaders

DECEMBER 11, 2022

Injectable and ophthalmic drug products pose a greater risk of harm to users, the agency said.

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FDA 40

Pharmacy Times

DECEMBER 11, 2022

Expert discusses the safety and efficacy of polatuzumab vedotin combined with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) as second-line treatment in a multicenter phase 2 study.

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Safety 26

Pharma Leaders

DECEMBER 11, 2022

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Pharmacy Times

DECEMBER 11, 2022

Expert discusses the effect of baseline transfusion burden and luspatercept dose level on response to treatment in patients with LR-MDS from the MEDALIST study.

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Patients 26

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. In November, the companies announced plans for a Phase I clinical trial of the combined vaccine candidate in healthy adult subjects.

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FDA Food and Drug Administration Food Safety 115