Tag Archive: healthcare reform

Mar 09 2012

After all the talk, where are we with biosimilars?


In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

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Feb 28 2011

Recap of the 20th CED Biotech/Life Sciences Conference

The 20th Annual Council for Entrepreneurial Development (CED) Biotech/Life Science Conference was held on 21-22 February 2011 in Raleigh, North Carolina.

Jan 28 2011

How will Healthcare Reform Impact Your Next Investigator Meeting?

The new Healthcare reform legislation can be debated by Americans for days on end, but tucked in among all of the changes for Medicare beneficiaries, pre-existing conditions, and the effects on small business owners lays a provision that most layman would not even notice. This provision, however, has the attention of US drug and device manufacturers and cannot be ignored.

Apr 19 2010

Drug/Biologic/Device Highlights from the Health Care Reform Bill

Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions in the Patient Protection and Affordable Care Act (commonly known as the “Health Care Reform …

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Mar 25 2010

Biotech Wins Protection From Biosimilars

Love is the power to see similarity in the dissimilar. – Theodor Adorno When President Obama signed the healthcare reform legislation into law, he also handed a major victory to biotech companies. Unless you’ve been stranded on a deserted island with only a volleyball for company, you’re aware that most of the press and analysis …

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