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GMO Notification and Labeling Bill Introduced in the House

Last month, Rep. Mike Pompeo (R-KS) introduced a bill in the House to amend the Food, Drug, and Cosmetic Act with respect to the commercialization of food produced from, containing, or consisting of a bioengineered organism. ...more

5/8/2014 - FDA FDCA Food Safety GMO

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

4/11/2014 - Biosimilars FDA Healthcare Patents Pharmaceutical Pharmacies Prescription Drugs

FDA Approved 27 New Drugs in 2013

Last month, the U.S. Food and Drug Administration (FDA) announced that the agency approved 27 new drugs and biological products in 2013. According to the FDA release, the 27 new molecular entities (NMEs) that were approved...more

1/9/2014 - FDA Pharmaceutical Prescription Drugs

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

3/7/2013 - Abbott Laboratories Affordable Care Act Biologics Price Competition and Innovation Act of 2009 Biopharmaceutical Biosimilars FDA Generic Drugs Licenses Patents Pharmaceutical

FDA FY2012 Drug Approvals Equal FY2011 Mark

Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012. The 35 approvals equaled the number of approvals for...more

1/23/2013 - Drug Approvals FDA Personalized Medicine Pharmaceutical

Top Stories of 2012: #4 to #7

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

1/3/2013 - Biotechnology DNA FDA Infringement Patent Exhaustion Patents Pharmaceutical Safe Harbors

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