News & Analysis as of

Stem cells

Better Healthcare Newsletter from Patrick Malone - December 2017

Here's a puzzle. Although 95 percent of Americans adults say they support organ donations, just 54 percent of us sign up to give. The unmet need is a killer, literally: 8,000 Americans died this year for lack of a timely...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

by Hogan Lovells on

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

Can Employees Pay for Cord Blood Storage with an HRA, FSA or HSA?

The blood remaining in the umbilical cord after childbirth contains stems cells which may be used in a variety of medical treatments. Many parents of newborns are seeking to save this “cord blood”, either with the hopes of...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

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

Better Healthcare Newsletter from Patrick Malone - September 2017

Deflating the hype and exposing the risks of stem-cell treatments - Stem cells and regenerative medicine—a promising and complex field that has been a preoccupation of no less than popes, presidents, and top health policy...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

FDA announces actions regarding stem cell treatments

by Dentons on

Together with new guidance regarding the potential regulatory pathways for gene therapies, the FDA announced on Monday, August 28, 2017, that it will be taking action against companies providing unapproved stem cell...more

FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against “Unscrupulous Actors”

The U.S. Food and Drug Administration (FDA or Agency) has become increasingly active in stem cell and regenerative medicine product regulation within the past year previously announcing that it would release a modified...more

FDA Seizes Stem Cell Therapy—A First of Many?

by Hogan Lovells on

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more

Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

by Knobbe Martens on

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...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

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Bipartisan Health Policy Bills Advance

by Reed Smith on

On September 8, 2015, the House of Representatives approved the following bipartisan bills by voice vote: ..H.R. 1344, the Early Hearing Detection and Intervention Act of 2015 – to reauthorize a program for early...more

Energy & Commerce Committee Approves Bipartisan Health Bills

by Reed Smith on

On July 29, 2015, the House Energy & Commerce Committee approved the following bipartisan bills that aim to improve health care for newborns, infants, and children...more

Inventorship, Ownership Issues Cause Dismissal of Suit

by Foley & Lardner LLP on

On July 22, 2015, the U.S. District Court for the District of Maryland dismissed a long standing patent infringement suit brought by StemCells, Inc. against Neuralstem, Inc., on the ground that all those with an ownership...more

House Panel to Review Bipartisan Bills to Improve Health Care for Infants/Children

by Reed Smith on

On June 25, 2015, the Energy & Commerce Health Subcommittee will review three bipartisan bills that aim to improve health care for newborns, infants, and children. Specifically, members will discuss: H.R. 2820, the...more

Patenting Stem Cells in View of the USPTO’s New Interim Guidance

by Foley & Lardner LLP on

Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for...more

Some Human Embryonic Stem Cells Are Once Again Patent-eligible in Europe

Last Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human...more

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