ARTICLES BY ANNA ROSE
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The Generic And Biosimilar Markets: Are They Really That Different?10/19/2015
As the FDA continues to compose guidances on the labeling and interchangeability of biosimilar medicines, there remains one big, overarching concern in the industry, and that is making sure biosimilar medicines are not treated as small molecule generics. But should we really be considering the two types of drugs as drastically different as we have been over the past few months?
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Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?9/1/2015
Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?
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New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market7/29/2015
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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FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More7/17/2015
What FDA decisions have you missed recently?
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Human Error: What Pharma Should Know And Do About It — Part One7/16/2015
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 More7/10/2015
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 More6/11/2015
What regulatory decisions have you missed recently?
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Will Pay-For-Performance Really Suit The Cancer Drug Space?6/9/2015
If Express Scripts should have its way, what would happen to inter-industry competition between the pharma players — specifically in the cancer space? If price tags are altered based off a drug’s performance, it seems to me the industry and its ways of quantifying success and leadership in the market will be faced with change as well — but it’s not entirely clear it will be what Express Scripts had in mind.