Stem cells

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 4/29/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

Supreme Court Will Not Hear Stem Cell Funding Petition

by Joseph P. Hammang, Alexander Hecht, Robert C. Skinner | Mintz Levin on 1/15/2013

..The on again, off again nature of federal funding for human embryonic stem cell (hESC) research has created a great deal of uncertainty for academic scientists, major research medical centers, venture capital investors,...more

Supreme Court Denies Certiorari in Stem Cell Funding Case

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 1/8/2013

In an order issued earlier today, the Supreme Court denied certiorari in Sherley v. Sebelius, ending the efforts by two adult stem cell researchers to prevent the National Institutes of Health (NIH) from funding research...more

How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

by Fuerst Ittleman David & Joseph, PL on 12/28/2012

In the December 26, 2012 edition of the Food & Drug Law Institutes (FDLI) Policy Forum, Andrew Ittleman of Fuerst Ittleman David & Joseph took on the question of how FDA may more reasonably regulate autologous stem cell...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

News from Abroad: UK IPO Stem Cell Decisions Raise Questions Concerning the Brüstle Decision

by McDonnell Boehnen Hulbert & Berghoff LLP on 12/3/2012

Originally published in the Forresters on December 02, 2012. Two UK applications were rejected by a UK examiner on the ground that they constituted the 'use of human embryos for industrial or commercial purposes',...more

News from Abroad: Emerging Practice of the European Patent Office on Stem Cell Inventions

by McDonnell Boehnen Hulbert & Berghoff LLP on 11/26/2012

Originally published in Forresters on November 25, 2012. Is There Light at the End of the Tunnel? - It is clear from an emerging practice of the European Patent Office (EPO) that they were not widely impressed...more

U.S. Supreme Court Asked to Review Federal Funding of Human Embryonic Stem Cell Research

by Foley & Lardner LLP on 10/18/2012

On October 10, 2012, two pro-life groups petitioned the U.S. Supreme Court to review and reverse the U.S. Court of Appeals for the District of Columbia Circuit Court’s decision allowing the continued federal funding of...more

U.S. Supreme Court Agrees to Review Case That May Impact Patented Stem Cell Technologies

by Foley & Lardner LLP on 10/8/2012

On October 5, 2012, the U.S. Supreme Court agreed to review the issue of whether the Federal Circuit erred by (1) refusing to find patent exhaustion that eliminates the right to control or prohibit the use of an invention...more

News from Abroad: EPO Codifies CJEU's Decision on Human Embryonic Stem Cells

by McDonnell Boehnen Hulbert & Berghoff LLP on 9/6/2012

On 8 October 2011, the Court of Justice of the European Union's (CJEU) handed down a landmark judgment on the correct interpretation of Article 6(2)(c) of the Biotechnology Directive (98/44/EC) relating to the patentability...more

Federal Stem Cell Funding Approved by Appellate Court

by Foley & Lardner LLP on 8/28/2012

Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s...more

Cultured Stem Cells — Court Rules on the Regenexx Case

by K&L Gates LLP on 8/3/2012

As discussed in our prior K&L Gates Alert, “Cultured Stem Cells for Autologous Use: Practice of Medicine or FDA Regulated Drug and Biological Product?”, in 2010 the Food and Drug Administration (“FDA”) brought an action...more

IP Provisions and ROI for State-Funded Stem Cell-Based Products and Technologies in California

by Fenwick & West LLP on 6/1/2012

The California Institute of Regenerative Medicine (CIRM) reaches the end of its initial charter in 2017 and recently published its Transition Plan. The plan is a roadmap to sustained development of stem cell-based...more

Navigating the Evolving Regulation and Commercialization of Stem Cell Research

by McDermott Will & Emery on 3/22/2012

Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage. Given that in the fall of 2011 the Court of Justice of the...more

Alabama student optimistic about post-crash stem cell treatment

by Johnston, Moore & Thompson, Huntsville... on 6/8/2011

Those behind the use of embryonic stem cell treatment call the option a "hopeful experiment." It's not being widely used yet; in fact, only one Alabama patient has gone through the controversial treatment. Last year, a...more

SCI Stem Cell Clinical Trial Awarded $25 Million Dollars

by Demas Law Group on 5/17/2011

The California Institute for Regenerative Medicine (CIRM) has recently awarded $25 million dollars to “the first clinical trial based on cells derived from human embryonic stem cells that has been approved by the Federal Drug...more

MultiStem: A Promising New Stem Cell Therapy Still Under Investigation

by Demas Law Group on 1/24/2011

Every new promising approach to treating spinal cord injuries (SCIs) is critical to the United States since close to 1,200,000 Americans are currently battling some form of this disability. Furthermore, another 12,000 to...more

Is Stem Cell Research Moral? Does Roe v. Wade help?

by Kevin Rider on 2/23/2010

I was asked to argue the "pro" side of this topic because I stated I was against it. Did my own paper change my mind? I won't tell. Embryonic stem cell research (ES) has been described as one of the most significant...more

NIH Approves First Human Embryonic Stem Cell Lines Under New NIH Guidelines

by Ice Miller LLP on 12/4/2009

The National Institutes of Health, a component of the U.S. Department of Health and Human Services, approved the first human embryonic stem cell lines under the new NIH Guidelines for Human Stem Cell Research. ...more

Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements by Kalah Auchincloss

by Foley Hoag LLP on 9/9/2009

In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HES) research. The possibility of new federal funding opportunities, in...more

NIH Releases Guidelines for Federal Funding of Human Embryonic Stem Cell Research

by Foley Hoag LLP on 5/12/2009

According to the National Institutes of Health (“NIH”), “studies of human embryonic stem cells may yield information about the complex events that occur during human development… and could provide information about how...more

Anticipated Policy Changes for Embryonic Stem Cell Research: Funding Under the Obama Administration

by Duane Morris LLP on 1/30/2009

Soon after the November 2008 election, then-President-elect Obama signaled his intention to issue executive orders to repeal decisions made by the Bush administration on diverse policies, including the limitations imposed on...more

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