News & Analysis as of

Life Sciences Stem cells

Gilead to Acquire Kite Pharma for $11.9 Billion

by Knobbe Martens on

Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion. According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic...more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

The (Nuts and Bolts) of Application Formalities in China

China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

2016 – a year at a glance

by FPA Patent Attorneys on

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

by Mintz Levin on

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

University of Pittsburgh v. Cellerix (PTAB 2013)

The Patent Trial and Appeals Board (PTAB), a creation of the Leahy-Smith America Invents Act that replaced the Board of Patent Appeals and Interferences (BPAI) overruled the Reexamination Unit's decision that the claims of...more

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

by Reed Smith on

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

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

by Fenwick & West LLP on

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

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