Increase the Value of your Prodrug Asset Under 505(b)(2): An Alkermes Program Update
A prodrug developed via the 505(b)(2) pathway can improve an existing therapeutic while increasing the…
Results for "prodrug"
The Prodrug Benefit of Utilizing the 505(b)(2) Pathway
Designing a new drug from scratch is costly and time-consuming. One attractive option to differentiate…
Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?
The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for…
What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration...
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Media and Press
Latest Media and Press Press Release - Premier Consulting Appoints William Bainbridge as Head of...
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Advantages of the 505(b)(2) Pathway in Nonclinical Development
The 505(b)(2) new drug application (NDA) pathway can provide unique advantages from the nonclinical development…
The Hypertension Fixed-dose Combination Product Guidance: Straight from the 505(b)(2) Playbook
The FDA just released a new draft guidance on developing fixed-dose combination antihypertensive products. While…
Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway
At Premier Consulting, we are often asked for strategic advice on drug development programs seeking…
Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?
As the 505(b)(2) experts, Premier Consulting has received several enquiries about developing deuterated drugs as…
Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a…
Faster Approval of Combination Drug Products Via the 505(b)(2) Pathway
On April 11 and 12, 2016, Ken Phelps, Strategic Advisor at Premier Consulting, spoke at…
Quality Metrics – Coming Soon to Your Manufacturing Facility
The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for…
The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams
The “cliff” has passed for pharma but has just begun for generics companies that have…
Nonclinical Bridging: Most 505(b)(2) Programs Don’t Require Full Tox Package
In this blog post, we will examine a case study that illustrates various factors that…
Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
At Premier Consulting, we believe that the 505(b)(2) drug development pathway is best used when…
505(b)(2): Repositioning, Repurposing or What?
Some define repositioning as the process of examining alternate indications for drugs that have failed…
FDA’s Determination of Vyvanse as NME Upheld
On March 4, 2010 the U.S. District Court for the District of Columbia agreed that FDA…