FDA study asks whether drug names change how consumers, docs view meds

FiercePharma | January 22, 2020

The FDA wants to know what, exactly, is in a drug name. Specifically, can a brand moniker determine how consumers and healthcare providers perceive the drug? So, the agency has launched a study to determine whether names sway opinions about a drug's effectiveness. Drugmakers submit their proposed names to the FDA for approval, but the companies often hire branding agencies to help create a name. The agency’s job is to make up brand names that draw relevant connections but follow FDA guidelines. For instance, pharma companies have to avoid names that specify a drug's attributes or names that are too similar to those already on the market.

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Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

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Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

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Ozette Technologies Announces New Collaboration with Umoja Biopharma to Accelerate Biomarker Discovery in Preclinical Studies

Businesswire | June 28, 2023

Ozette Technologies, Inc., a technology-driven life sciences company, announced its collaboration with Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers. Umoja will use Ozette’s AI-powered single-cell technology for their preclinical studies. As part of this work, the Ozette Platform™ will be used to provide research and development (R&D) support and evaluate biomarker endpoints from preclinical tumor-bearing, humanized mouse models. Humanized mouse models are often deployed in preclinical studies as a tool for modeling human immune responses in the evaluation of potential therapeutics and treatment effects before first-in-human studies. The goal of this collaboration is to help derive insights that have the potential to catalyze Umoja’s therapeutic program development. “Our mission is to unlock the power of the immune system using computation and machine learning. As a result, we can quickly understand how the immune system is evolving and what that means for a therapy and a patient at the single-cell level,” said Dr. Ali Ansary, CEO and Co-founder of Ozette. “This collaboration with Umoja is an important opportunity to continue showcasing Ozette’s technology and innovative impact on the vast variety of therapeutic indications, including cutting-edge T-cell treatments.” Umoja and Ozette share a common mission to increase the efficiency of drug development and expand access to transformative immunotherapies through technology innovation. The partnership will leverage Ozette Endpoints™ and Ozette Discovery™ to enable both companies' multidisciplinary scientific and bioinformatic teams to collaborate and expand the benefits of CAR T-cell immunotherapy to patients in need. “Our collaboration with Ozette is the next step in expanding the value of our preclinical data by leveraging their advanced single-cell technology,” said Ryan Larson, Ph.D., Senior Vice President of Translational Science at Umoja. “The Ozette Platform will allow us to efficiently distill complex biology, that traditionally relies on manual analysis, into actionable insights rapidly. Together, we’re able to gather a deeper and wider set of preclinical insights from our data which, in turn, allows us to increase the efficiency of developing our transformative therapeutics. We’re excited to expand our R&D efforts with Ozette on broader applications at Umoja.” About Ozette Ozette Technologies, Inc. is engineering a transformative leap in measuring and understanding the immune system. The Seattle-based life sciences company is building a groundbreaking high-resolution, single-cell immune monitoring platform and corpus of high-resolution data leveraging its differentiated novel ML technologies. Ozette’s Assay-to-Insights product launch combines three technologies developed by the company: world-class data generation at the Ozette Laboratory under Good Clinical Laboratory Practices (GCLP) guidelines, rapid computational monitoring of pre-defined biomarker endpoints using Ozette Endpoints™, and unbiased discovery and annotation of single-cell data through Ozette Discovery™. Insights generated from Ozette Endpoints™ and Ozette Discovery™ are made available through the Ozette Platform™, a cloud-based system that leverages automation enabling scientific teams to interact and explore their data. Founded in late 2020, Ozette was spun-out of the Fred Hutchinson Cancer Center and incubated at the Allen Institute for AI. Ozette has since published their technology in a number of journals including Nature, Science, and Cell. Ozette’s interdisciplinary team is made up of a deep bench of scientists, statisticians, engineers, and designers with a wide range of experience spanning Genentech, Google, Microsoft, Amazon, Airbnb, and more. Ozette’s team also includes leaders and pioneers in the field of medical research and single-cell analysis, including founders: physician Ali Ansary, and scientists Greg Finak, Evan Greene, and Raphael Gottardo. Ozette believes that mapping and studying the complexity of the immune system unlocks insights that accelerate research and ultimately derive better immunotherapies; we believe in better data. About Umoja Biopharma Umoja Biopharma, Inc. is an early clinical-stage company advancing an entirely new approach to immunotherapy. The Company is a transformative multi-platform immuno-oncology company founded with the goal of creating curative treatments for solid and hematological malignancies. Founded based on pioneering work performed at Seattle Children’s Research Institute and Purdue University, Umoja’s novel approach is powered by integrated cellular immunotherapy technologies including the VivoVec™ off-the-shelf in vivo delivery platform, the RACR™/CAR in vivo cell expansion/control platform, and the TumorTag™ targeting platform. Designed from the ground up to work together, these platforms are being developed to create and harness a powerful immune response in the body to directly, safely, and controllably attack cancer. Umoja believes that its approach can provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives.

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Pharma Tech

PharmaKinnex and Data360 Team Up to Extend Client Reach and Improve Patient Access

PRNewswire | July 24, 2023

PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes. From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions. "The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector." Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage. "We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients." Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria. Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment. About PharmaKinnex PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems. About Data360 With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.

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Pharmacy Market

Nexus Pharmaceuticals Receives FDA Approval for 0.9% Sodium Chloride Injection

businesswire | August 31, 2023

Nexus Pharmaceuticals LLC announced it has received U.S. Food and Drug Administration (FDA) approval for 0.9% Sodium Chloride Injection, USP in 10mL and 20mL Single-Dose Vials. “This product is part of an expanding portfolio of products that address critical healthcare challenges,” said Omair Ahmed, Chief Operating Officer. “Sodium Chloride Injection is used to treat patients every day in every hospital in the United States. We are grateful to be able to bolster the supply of this critical-need product.” Nexus Pharmaceuticals’ 0.9% Sodium Chloride Injection, USP is expected to launch in October and will be available in cartons of 25 vials. About 0.9% Sodium Chloride Injection, USP Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. About Nexus Pharmaceuticals LLC Nexus Pharmaceuticals LLC, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

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