Legal updates for: biosimilar

by Holland & Knight LLP on 5/22/2013

... to the start of the 2013 Florida legislative session, President Gaetz and Speaker Weatherford outlined a joint agenda that included tackling ethics, elections, campaign finance, state pensions and higher education. The Florida House and Senate worked together to pass legislation that made significant reforms to these policy areas, often with... more

by Mintz Levin - Health Law on 5/15/2013

... This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups Scheduled. Excerpt from Implementation of the Affordable Care Act - On May 2nd the Business Roundtable sent a letter to President... more

by McDermott Will & Emery on 5/7/2013

... (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological product. This latest guidance focuses on the mechanics of requesting, pre... more

by McDermott Will & Emery on 4/19/2013

... April 10, 2013, President Obama released his budget proposal for fiscal year (FY) 2014 (the Budget). The President reiterated his long-standing goal of reducing the deficit by $4.3 trillion over 10 years and his willingness to do so in part by saving $400 billion from changes to federal health programs, including Medicare and Medicaid. According... more

by Fenwick & West LLP on 4/4/2013

... This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor - Quick Updates: - The Federal Circuit Provides Guidance on When to Consider Judicial Economy... more

by Mintz Levin - Health Law on 3/26/2013

... This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups Scheduled. Excerpt from Leading the News - On March 21st the House approved a stopgap spending measure by a 318-109... more

by McDonnell Boehnen Hulbert & Berghoff LLP on 3/7/2013

...aboratories 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 (BPCIA) that cite reference products (biologics) for w... more

by McDonnell Boehnen Hulbert & Berghoff LLP on 1/3/2013

... 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 we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Monday and... more