Our Blog

Planning for 505(b)2 Commercial Success

October 17, 2018
Unlike generics and biosimilars, 505(b)2 regulatory products likely involve a unique claim. While 505(b)2 asset approval relies on reference product core clinical program data, ideal 505(b)2 candidate...
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Fed-Up Hospitals are Starting Their Own Drug Company to Lower Generic Drug Prices

February 12, 2018
The impact of drug shortages is not new within the healthcare system, particularly at the hospital level, nor is the cost of drugs, however Fed Up with Drug Companies, Hospitals Decide to Start Their ...
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FDA Continued Rejections of Citizen Petitions Highlights Key Lifecycle Challenges for Biologic Manufacturers

January 24, 2018
Citizen petitions have historically been a tool in the brand manufacturer’s toolkit of “product lifecycle management” but are fast becoming obsolete options due to mounting FDA resistance. A rec...
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The FDA approved Dupixent for moderate-to-severe atopic dermatitis

April 14, 2017
  The FDA approved Dupixent On March 28th, the FDA approved Dupixent for moderate-to-severe atopic dermatitis. One of the most highly-anticipated approvals of 2017, Dupixent is the latest output ...
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Why Drug Pricing is in the News Now and What Can Be Done About It?

March 3, 2017
Why drug pricing is in the news now and what can be done about it? From Turing Pharmaceuticals to Mylan, there has been no shortage of news coverage on the high cost of prescription drugs. While polit...
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Key Challenges Facing Obamacare Repeal and Replace Plan

February 3, 2017
ACA repeal and replacement complicated by two key challenges...
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How Pharma Can Prepare for the Patent Cliff

February 2, 2017
Extending market exclusivity and responding properly to the volume of recent patent expiries are critical to the sustainability of pharmaceutical corporations.  In the midst of the 2012-2019 patent c...
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Innovation in Pharma Sees Drop in 2016

January 20, 2017
2016 proved to be less than stellar for pharmaceutical companies for a number of reasons, not least being a low point for marketing approval of new products (22 in 2016). While the industry continues ...
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Vermont Drug Price Transparency Bill

December 14, 2016
Vermont recently became the first state to pass a law requiring pharmaceutical manufacturers to either disclose and explain company rationale for product price increases or face legal consequences. Pe...
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Biking for a World Without Diabetes

December 1, 2016
Every year, our bike-enthusiast team members eagerly await the national American Diabetes Association (ADA) Tour de Cure event. It’s a chance for the team to get some fresh air and exercise while he...
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