PRACTICE MANAGEMENT

AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance

Farxiga | January 07, 2021

AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance
Pushing for another endorsement for SGLT2 prescription Farxiga in persistent kidney illness (CKD), AstraZeneca a year ago posted amazing information in its critical preliminary. Presently, the FDA has acknowledged its CKD application and granted a need survey, setting up a choice for the subsequent quarter—and putting Farxiga significantly farther in front of its future adversaries.

In that preliminary, named Dapa-CKD, AZ's Farxiga in addition to standard of care cut the joined danger of deteriorating kidney capacity or demise brought about via cardiovascular or kidney issues by 39% over fake treatment in certain CKD patients. Furthermore, the medication cut the danger of death from any reason by 31%.

Initially endorsed to control glucose, Farxiga a year ago scored a class-first FDA gesture to lessen the danger of major cardiovascular occasions in patients with cardiovascular breakdown—regardless of whether they have diabetes. Presently, AstraZeneca is planning to change the therapy worldview in persistent kidney sickness. Johnson and Johnson's Invokana conveys a FDA endorsement in diabetic kidney infection, however Farxiga is gunning for a gesture in ongoing kidney sickness with or without type 2 diabetes.

At the point when AZ introduced its definite stage 3 Dapa-CKD results back in August, an executive said the information "truly can possibly modify" clinical course readings. Before that, the organization halted its preliminary early last March after break information "demonstrated Farxiga's advantages sooner than initially envisioned."

The FDA's Wednesday move "presents to us a bit nearer to conveying this new therapy choice for the large numbers of patients living with ongoing kidney illness in the U.S.," AZ's chief VP of biopharma R&D, Mene Pangalos, said in an assertion. "Farxiga can possibly be a really groundbreaking medication across an expansiveness of illnesses, including type 2 diabetes, cardiovascular breakdown with diminished discharge division and, whenever endorsed, constant kidney infection."

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Tolga Tanguler, President North America for Pfizer Rare Disease speaking to eyeforpharma about what inspires him to work in pharma.eyeforpharma’s youtube channel now broadcasts the best presentations, chats and interviews from our conferences.eyeforpharma’s mission is to make the pharmaceutical industry more open and valued. Our conferences are where leading minds gather to discuss and share strategies that drive value for patients and shine a light on pharma excellence. Look for talks on patient-centricity, multi-channel marketing, value-added services, real-world data and sales force effectiveness.

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Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Adare Pharma Solutions | December 02, 2021

Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare's commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare's portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms. "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together. The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients." Vivek Sharma, Chief Executive Officer of Adare Dr. Song Li, Frontida's Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets." Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare's manufacturing footprint to seven sites globally and expands Adare's integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma. Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction. About Adare Adare Pharma Solutions is a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, development services, and manufacturing. The Company utilizes its differentiated pharmaceutical technology and microbiome platforms to develop novel, improved medicines, and therapies for the global market.

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Movilitas.Cloud™ VRS Solution Clarifies DSCSA Verification for Pharmaceutical Wholesale Distributors and Manufacturers

Movilitas | July 13, 2020

Movilitas announced today the availability of its Movilitas.Cloud™ Verification Router Service (VRS) solution that simplifies the verification process and compliance for pharmaceutical wholesale distributors and manufacturers. The new mobile app provides an out-of-the-box solution for the November 2020 Drug Supply Chain Security Act (DSCSA) saleable returns verification deadline. With the upcoming regulation, wholesale distributors must verify the serialized product identifiers of saleable products that have been returned before they can be resold. With around 60 million pharmaceutical saleable returns in the U.S. market every year, wholesale distributors need a scanning solution that provides real-time feedback of product authenticity to minimize operational impacts.

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VigiLanz launches COVID Quick Start software that gives hospitals customizable real-time alerts and reports to manage viral outbreaks

Prnewswire | May 21, 2020

Hospitals can prepare for additional waves of COVID-19 and flu season in a matter of weeks, with no payments for six months. COVID Quick Start gives hospitals customizable real-time alerts and reports to manage viral outbreaks and exposures. COVID Quick Start uses VigiLanz's clinical surveillance platform to help hospitals adapt to the evolving conditions associated with respiratory viral illnesses. VigiLanz, a clinical surveillance company, today announced COVID Quick Start – a new solution that will enable hospitals to prepare for, prevent, and respond to the spread of COVID-19 and other respiratory viral illnesses. COVID Quick Start gives hospitals customizable real-time alerts and reports to manage viral outbreaks and exposures. Partnering with Datica for rapid deployment and supported by a team of VigiLanz's certified infection preventionists, the software is designed to alleviate the burden on hospital IT resources and clinical staff while increasing patient safety. The solution is available for free for the first six months, with flexible financing options thereafter. COVID Quick Start uses VigiLanz's clinical surveillance platform to help hospitals adapt to the evolving conditions associated with respiratory viral illnesses. The platform continuously pulls patient data from a variety of sources, including EHRs, and evaluates that data against rules that issue real-time alerts to clinical staff. The rules are designed to identify potential respiratory viral illnesses, ensuring early isolation and management of patients, and can also track disease clusters to identify local outbreaks and hospital acquisition. Our team recognized that VigiLanz's software and expertise could be tailored to address the unique issues presented by this pandemic and other potential respiratory viral illnesses, and that we could design a solution with a low barrier to entry, We've built COVID Quick Start as a solution that works both for hospitals with well-funded infection prevention programs, and those where resources may be more restricted. These organizations are facing a possible second wave of COVID-19 on top of the upcoming influenza season. Our Quick Start solution, which provides the basics of what hospitals need to monitor – such as exposures, early case identification, COVID-19 state and federal reporting requirements, and isolation – will help hospitals quickly prepare for what is coming. -Stacy Pur, Vice President of Product Development at VigiLanz Read More: COVID-19 BRINGS DIVISIONS ON HYDROXYCHLOROQUINE, REOPENING Recognizing the urgency for hospitals to have a solution like this in place, COVID Quick Start uses VigiLanz Connect, an API solution for hospital EHRs, powered by Datica, to deliver an even faster integration. This solution minimizes the burden on hospital IT resources and enables COVID Quick Start to begin improving patient safety as quickly as possible. Datica has deep expertise, with over 400 successful EHR integrations," said Dave Levin, MD, Chief Medical Officer at Datica. "We're proud to collaborate with VigiLanz as their EHR integration partner to quickly launch their COVID Quick Start product." COVID Quick Start provides an easy and low-risk entry to the full suite of VigiLanz's SaaS-based clinical surveillance solutions. VigiLanz helps health systems avoid or minimize harm, optimize clinical outcomes, and support preventive care by aggregating and monitoring disparate data in real time from across the EHR and other health system databases. VigiLanz was ranked No. 1 by KLAS Research this year across three categories – Antimicrobial Stewardship, Infection Control and Monitoring, and Pharmacy Surveillance. This is the third year in a row it has earned Category Leader designations from KLAS. About VigiLanz Founded in 2001, VigiLanz is a privately held, rapidly growing provider of SaaS-based clinical surveillance solutions. The firm is focused on aggregating disparate EHR transactional workflow and documentation data across health systems to identify real-time clinical issues that avoid or minimize harm, optimize clinical outcomes and support preventive care. 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Spotlight

Tolga Tanguler, President North America for Pfizer Rare Disease speaking to eyeforpharma about what inspires him to work in pharma.eyeforpharma’s youtube channel now broadcasts the best presentations, chats and interviews from our conferences.eyeforpharma’s mission is to make the pharmaceutical industry more open and valued. Our conferences are where leading minds gather to discuss and share strategies that drive value for patients and shine a light on pharma excellence. Look for talks on patient-centricity, multi-channel marketing, value-added services, real-world data and sales force effectiveness.