Drug Delivery

Intarcia faces FDA refusal to approve as push to get diabetes delivery system to market enters endgame

By Nick Paul Taylor

Intarcia Therapeutics has hit another roadblock at the FDA in its effort to win approval for a GLP-1 delivery system. After issuing two complete response letters and denying three dispute resolution requests, the FDA now plans to refuse to approve Intarcia’s filing for approval in Type 2 diabetes.

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Sunovion cashes in sublingual Parkinson's drug, selling EU rights to Bial

By Nick Paul Taylor

Sunovion Pharmaceuticals has found a taker for the European rights to sublingual Parkinson’s disease drug Kynmobi. Bial is on the other side of the deal, putting together an undisclosed financial package to secure rights for a treatment it plans to submit for approval by the end of the year.

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Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval

By Beth Snyder Bulik

Friendly epinephrine? Meet Neffy, ARS Pharmaceuticals’ nasal spray epinephrine to treat severe allergic reactions to food, medicines and insect bites. Neffy, now awaiting FDA approval, aims to flip the script on past epinephrine autoinjector marketing that focused on fear around the severe reactions called anaphylaxis.

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Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

Sponsored by: XIFIN inc.

Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

Sponsored by: EVERSANA

Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Sponsored by: Thermo Fisher Scientific

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Five Trends to Watch in the European Market Access Environment

Sponsored by: Blue Matter

This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies.

eBook: Get solutions to market faster

Sponsored by: Box

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

Content Hub: Remarque Systems Resource Hub

Sponsored By: Remarque Systems

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

Webinar: Patient-Focused Drug Design: Through the Lens of Real-World Case Studies, Clinical Evidence and Advanced Delivery Solutions

Sponsored by: Catalent

Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes.

eBook: Drug Design and the Patient Journey

Sponsored by: Catalent

This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Sponsored by: Catalent

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.