Formulation Development Featured Editorial
-
First In Line: FDA Vs. EMA Biopharma Approval Times
1/20/2021
The majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy, but should they? This article reviews data from more than 200 new therapeutics approved by the FDA over the past five years to determine if there really is a difference in approval timelines between the FDA and EMA.
-
3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers
1/13/2021
Without changes in the market for generics, profits will likely continue to erode in the sector as products become more commoditized. Generic drug makers do have some recourse to help improve margins. We’ve outlined three approaches that are not mutually exclusive for generic drug manufacturers’ future success. Each has its own set of investment requirements, risks, and growth potential.
-
Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The M&A And Commercial Landscape
12/14/2020
In this last part in a three-part series, we cover the M&A and commercial landscape implications, including historical and future deal trends, challenges in developing a successful commercial strategy, and what to watch out for as the NASH industry continues to reach new milestones.
-
Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The Second-Wave Candidates
12/7/2020
In Part 1 of this three-part series, we discussed NASH, the market for treatments, the first wave of NASH drugs (at Phase 3) poised to change the management paradigm, and the currently ambiguous pricing/reimbursement landscape. Here in Part 2, we look to the most promising second wave of NASH drugs.
-
Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: Sizing Up The First Wave
11/30/2020
NASH has remained a relative graveyard of drug development over the past 40 years: no disease-specific approved therapies have made it to market. This article analyzes the first wave of drugs (at Phase 3) poised to change the NASH management paradigm and shape the ambiguous pricing and reimbursement landscape.
-
Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity
11/4/2020
Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants.
-
Overcoming The Challenges Of Patient-Centric Specification Setting
9/30/2020
The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.
-
How To Make Your CDMO Selection An Award-Winning Event
9/23/2020
There are many considerations when it comes to selecting a partner. Cost is always a major factor, but it’s important to also consider some of the other project requirements and how well they match the skills of any particular CMO.
-
One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies
9/8/2020
Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.
-
Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics
5/15/2020
In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.