Tag Archives: Legal

Merck in Gender Bias Wrangle

Four class representatives have been added to a class-action gender-discrimination employment suit originally filed last May against Merck & Co. in New Jersey.
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Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
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Drug Patents Under Fire in Brazil

by Ryan O’Quinn & Sanya Sukduang One of the most promising pharmaceutical markets of the future is Brazil, a nation of nearly 200 million people with a universal healthcare system.  Brazil’s infamously overloaded patent system has undergone a series of recent reforms.  One such “reform,” however, greatly complicates biopharmaceutical patent practice: any Brazilian patent application […]
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U.S. Biosimilars Under Threat?

by D’vorah Graeser, Graeser Associates International While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for […]
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology | Also tagged , , | 1 Comment

Justice to Pharma: "Do the Perp Walk!"

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next? The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud […]
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