Articles by Anna Rose Welch
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Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”
8/12/2015
In 2015, the generics market saw several players jump ship and one company grow significantly — and to some, alarmingly — larger. If buyers are consolidating and causing generics companies to consolidate, isn’t it natural to expect a similar trend to hit the biosimilars market when it’s more established?
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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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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 News Roundup: Otsuka, AstraZeneca, Ipsen, And More
7/17/2015
What FDA decisions have you missed recently?
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Human Error: What Pharma Should Know And Do About It — Part One
7/16/2015
When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.
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Venture Philanthropy: Is It Really Promoting Patient Centric Drug Development?
7/14/2015
Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.
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FDA News Roundup: Pfizer, Eli Lilly, Vertex, And More
7/10/2015
What FDA decisions have you missed recently?
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Is Pharma Truly Equipped For Transparency?
7/8/2015
As the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?
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FDA Roundup: Sanofi, Genentech, Apitope, Retrophin, And More
6/11/2015
What regulatory decisions have you missed recently?