Editors' Desk
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“Perfect Storm” Demands A Pharma Supply Chain Overhaul
8/10/2015
According to some pharmaceutical industry experts, a pending explosion in biologics coupled with universally inflexible supply chains are creating a perfect storm that demands and overhaul in order to meet demand. Here’s what you can do today.
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TPP Negotiations Stall, Hold Back Biosimilars Market
8/3/2015
As if the biosimilar naming debate between brand-name pharmaceutical companies and generic drugmakers wasn’t enough, these two sides continue to challenge each other — this time, over biologics data exclusivity in the ongoing Trans-Pacific Partnership (TPP) negotiations.
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New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market
7/29/2015
After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed.
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Bringing Legacy Pharma Manufacturing Facilities Into The Modern Age
7/29/2015
Keeping your pharmaceutical manufacturing facilities up-to-speed with cGMP (current Good Manufacturing Practices) can be challenging, particularly when dealing with legacy facilities. This article provides some best practices on how to modernize legacy sites.
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The Biosimilar Naming Debate: Is Pharma Just Afraid Of Competition?
7/27/2015
The Boston Globe recently published an article revisiting the industry’s ongoing struggle to determine a labeling system for biosimilars— a challenge that reflects the industry’s insecurity over what seems to be an increasingly destabilizing generics environment.
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FDA Paves Way For Intelligent Pills
7/17/2015
The FDA’s approval of various edible sensor and tag technologies now makes it possible to tie digital data to traditional medicines. What does this development mean for pharmaceutical manufacturers?
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Are Your Single-Use Sensor Tests Set Up To Fail?
7/9/2015
When it comes to testing methods, experts warn that the same testing methods used on stainless-steel sensors should not be used for single-use sensors. If an attempt is being made to recreate results achieved with a traditional sensor, it’s very possible for those results to appear unfavorable with a single-use sensor.
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Leadership At “The Best CMO In The World”
7/8/2015
An Exclusive Interview on Leadership with Samsung BioLogics President & CEO Tae Han Kim.
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The Drums Of BIO 2015: Dollars, Nano and Data
7/2/2015
Among the drumbeat of discussions at BIO 2015, three sounds reverberated above all: the first came from the bass drum of money; next was the razor-sharp tones of the nanotech snare drum; and hitting the cymbals for exclamation was “the whole digital field interacting with pharma and bio."
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DARPA’s Challenge: Manufacture A Biopharmaceutical In Less Than 24 Hours
6/26/2015
In order to ensure American soldiers fighting in remote locations overseas can receive the biopharmaceuticals they need on time, Defense Advanced Research Projects Agency (DARPA) created a program called Biologically-derived Medicines on Demand (Bio-MOD). The goal of Bio-MOD is to build a system that has the ability to create an on-demand biopharmaceutical in less than 24 hours. I spoke with one of the teams working on this effort about how they intend to accomplish this and what it could mean to the future of the industry.