On Monday, March 18, 2024, the Environmental Protection Agency (EPA) announced a ban on the use of chrysotile asbestos in the United States, including in products imported into the U.S....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The...more
The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”)...more
On December 8, 2022, the US Patent & Trademark Office (PTO) announced the launch of the Cancer Moonshot Expedited Examination Pilot Program (Cancer Moonshot Pilot). This program begins on February 1, 2023, and replaces the...more
In a key development for companies working to treat cancer, the U.S. Patent and Trademark Office (USPTO) has launched a potentially beneficial pilot program. This is the latest Biden Administration initiative stemming from...more
In support of President Biden’s Cancer Moonshot program, the USPTO announced that it will expedite the examination of patent applications that pertain to technologies to prevent cancer and cancer mortality...more
The Cancer Moonshot Expedited Examination Pilot Program (the new Pilot) will accord special status (earlier examination) to patent applications directed to technologies to prevent cancer and cancer mortality. The new Pilot...more
Today, Monday, March 28, President Joe Biden unveiled his Fiscal Year (FY) 2023 budget request, the second of his presidency. The $5.7 trillion proposal calls for $1.7 trillion in discretionary spending and $3.7 trillion in...more
President Biden, returning to an important health issue with which he has deep, tragic personal connection, has reprised a White House call for a “moon shot” campaign to keep the public and the medical establishment focused...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
On June 19, 2017, the U.S. Patent and Trademark Office (USPTO) announced that it would be extending the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be examined...more
The United States Patent and Trademark Office (PTO) issued a Notice today extending the Cancer Immunotherapy Pilot Program (Pilot Program), also known as “Patents 4 Patients.” The Pilot Program, which accelerates the...more
On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...more
Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...more
As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more
The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more
On January 12, 2016, President Barack Obama announced his goal of a nationwide “Cancer Moonshot,” with the ultimate goal of accelerating cancer research “to end cancer as we know it” during his State of the Union Address As...more
The United States Patent Office (USPTO) is implementing a new program that provides prioritized examination of patent applications relating to cancer immunotherapy (Cancer Immunotherapy Pilot Program or Program). The new...more
To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more
The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more
On January 12, 2016, President Obama announced a "National Cancer Moonshot" in his State of the Union Address. The Moonshot aims to achieve ten years of progress in cancer research within the next five years. The U.S. Patent...more
Last month, the U.S. Patent and Trademark Office published a notice in the Federal Register (81 Fed. Reg. 42328) regarding the implementation of a new pilot program that will provide for earlier review of patent applications...more