PHARMACY

Medisafe rolls out commercial offering for pharmaceutical companies

BY Gina Acosta

BOSTON — After several test pilots over the past year and a half, medication management platform Medisafe has launched Medisafe for Pharma.

Medisafe announced it has now bundled a number of services into a software license that helps pharmaceutical companies increase adherence to their medications while gaining actionable de-identified insights generated by complex self-learning algorithms analyzing billions of user engagement data points Medisafe has collected to date.

Medisafe's pharma offering simultaneously addresses all three major challenges attributed to non-adherence: patient quality of care (e.g. higher emergency and mortality rates), health care system costs (e.g. higher hospitalization rates) and lost revenues (e.g. fewer prescription refills). Pharma and pharmacies share the burden of lost revenues, estimated at $188 billion annually in the U.S. alone.

According to the company, Medisafe for Pharma enables pharmaceutical companies to:

  • significantly improve adherence from industry average rates
  • co-brand and customize the Medisafe interface for their patients
  • target and engage patients with educational content (e.g. videos, articles), patient assistance programs (e.g. copay cards), telecare services and other resources into the Medisafe "feed"
  • monitor ongoing adherence showing demographic trends, cohort-level insights, competitive benchmarking, etc.
  • automatically populate complex dosing schedules into the app to eliminate challenges of manual entry and ensure users receive accurate and timely reminder notifications
  • collaborate with Medisafe on patient recruitment
  • offer prescribers a provider-patient care management interface

"At Medisafe we are privileged to help patients stay in control of their health while offering pharma a vehicle to recoup billions of dollars in lost revenue and sustain their level of R&D investment towards therapies that  improve and extend life," said Jon Michaeli, Medisafe's EVP of marketing and business development. "Medisafe for Pharma is an essential 'Beyond the Pill' initiative for any pharmaceutical or life sciences company looking to increase adherence while engaging and learning from patients in the real world. Medisafe is uniquely positioned to produce high-ROI engagements given the millions invested, experience amassed, and user base established in the three plus years since its launch."

Medisafe's AI-driven personalized user interface (UI) delivers a tailored contextual experience to each user, and the company's role as an unbiased third party assists patients with all of their medications to improve their health holistically.

 

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PHARMACY

NPA launches warning letter database

BY Gina Acosta

WASHINGTON – The Natural Products Association has launched a free online tool for NPA members to view violations against the dietary supplement Good Manufacturing Practices.

Regulatory, compliance and QA/QC personnel of dietary supplement manufacturing facilities and retailers can use this information to monitor and track the top GMP violations by year and see how those trends are changing. The database will also allow end users to create their own reports.

“NPA is proud to announce a database for the industry that is more than just warning letters," said NPA CEO Dr. Daniel Fabricant. "It differentiates itself by capturing enforcement actions from various agencies. While it is searchable in many different ways you would think a warning letter database would be, it is also being designed to search disease claims/claim categories and allow for customized reports by member end users.”

The database is also beneficial for those responsible for labeling compliance to avoid the introduction of misbranded products into interstate commerce and those marketing with claims. The database also tracks enforcement actions taken by various agencies against companies. NPA wants their members to be able to view the entire scope of federal actions against the industry beyond a warning letter, including seizures, injunctions, forfeitures, and criminal actions.

“The benefit to industry is to learn, grow, and mature as a collective whole by correcting any mistakes or oversights now that someone else may be doing. FDA does not provide GMP compliance education, nor does it track these parameters for the industry. Industry stakeholders need these types of tools to see how the industry is adapting to change and improving their compliance.”

The database contains over 440 Warning Letters that have been publicly released by FDA, in addition to the enforcement actions taken by DOJ, FDA, and FTC since 2008.

The database is searchable by company name, product name, issue date, regulation, disease claims/claim category, and FDA action taken.

The comprehensive database is a valuable tool not only for dietary supplement manufacturers, but also retailers or consumers who want to see if FDA has found any issues with a company’s GMPs before purchasing their products. NPA will update the database weekly as new warning letters and enforcement actions are added through various public and federal agency media outlets.

 

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Report: Teva, Mylan may buy Pfizer’s overseas generic business

BY Gina Acosta

Teva Pharmaceutical and Mylan have shown preliminary interest in a Brazilian generic drug-making joint-venture in which Pfizer has a 40% stake, according to Fortune. (Fortune)

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