Research and Development

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Health Care E-Note - August 2016

The Alabama Natural Death Act contains the provisions on how an individual may plan for end-of-life decisions. Specifically, it outlines the requirements for a valid Advanced Directive and the removal and withdrawal of life...more

India’s New National Intellectual Property Rights Policy

On May 12, 2016 India published its National Intellectual Property Rights Policy (National IPR Policy) to raise awareness about the importance of IPR’s as a tool for financial and economic advancement. The mission of the...more

Brexit – Standards and Innovation: What’s Ahead?

This article is the second in an ongoing series of blog posts by Foley & Lardner LLP on the implications of the June 23, 2016 referendum decision in the United Kingdom (“UK”) to exit the European Union (“EU”). The first blog...more

Notice Of Open Meeting For Biomass Research And Development Committee

On August 8, 2016, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee in the Federal Register. The purpose of the meeting is to develop advice...more

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures

On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance concerning Institutional Review Board (IRB) written procedures. The guidance...more

Duty Savings Opportunity on Imported Scientific Instruments for Research Institutions

In Depth - US research hospitals and other research institutions that import scientific instruments should take advantage of a US customs procedure that allows foreign instruments to enter duty-free if imported by such...more

Hudson Institute Report Refutes UN Panel Stance on Impact of Patents on Access to Medicines

In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines. ...more

CFDA Solicits Comments on Drug Registration Rules

The China Food and Drug Administration (“CFDA”) recently published long-awaited and comprehensive revisions (“Revisions”) to the Drug Registration Rules (“DRR”). The Revisions are now open to public comments until August 26,...more

Biosimilars Development Updates

We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

White House Releases National Privacy Research Strategy

On July 1, James Kurose, the Assistant Director for Computer and Information Science and Engineering Directorate at the National Science Foundation, and Keith Marzullo, the Director of the National Coordination Office for...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Spotlight on Tennessee: R&D Exemption for Sales/Use Taxes

This State's industrial machinery exemption for sales and use tax purposes offers a significant benefit to manufacturers in Tennessee. With a general State tax rate of 7%, together with the added local tax rates, substantial...more

Intellectual Property and You: The University Edition

It may be July, but school is still in session. In this blog, I'll discuss another common but mysterious topic: intellectual property ownership, specifically in the university setting. Universities sponsor research, encourage...more

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

VA Partners with IBM’s Watson for Genomics

IBM’s Watson for Genomics and the U.S. Department of Veterans Affairs (VA) just announced a public-private research partnership to study genomics and provide tailored medical solutions to patients. This partnership is poised...more

CRS Prepares “Policy Primer” on Nanotechnology

The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in...more

China Issues China Manufacturing 2025 Strategy Sub-plan for Energy Sector

On June 21, the Ministry of Industry and Information Technology (MIIT) published the China Manufacturing 2025 – Energy Equipment Implementation Plan (Plan), jointly issued by the MIIT, the National Development and Reform...more

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...more

China FDA Solicits Comments on Priority Review Designation Procedure for Devices

The China Food and Drug Administration (“CFDA”) recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority...more

South Korea’s Biosimilars Industry Poised to Grow Domestically and Abroad

According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have...more

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

Solicitation Of Nominations For Biomass Research And Development Technical Advisory Committee

On May 25, 2016, DOE published a Notice For Solicitation of Nominations in the Federal Register to fill vacancies on the Biomass Research and Development Technical Advisory Committee (Committee)....more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

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