News & Analysis as of

Research and Development

Keeping Pace in Clinical Research: The Common Rule Picks up Speed

by Dickinson Wright on

In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more

Technology Development Pathways Workshop Will Highlight NNI Case Studies

by Bergeson & Campbell, P.C. on

The “Technology Development Pathways: Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017. According to NNI, the workshop will showcase application areas where...more

A road map to successful life sciences transactions in France

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

Sandia National Laboratories Studying Algae To Clean Polluted Water And Produce Biofuel

by Bergeson & Campbell, P.C. on

Sandia National Laboratories (Sandia) is investigating whether algae can be used to transform the Salton Sea, one of California’s largest and most polluted lakes, into a productive and profitable resource. The Salton Sea...more

Mazumdar-Shaw Comments On Biocon’s Biosimilar Pipeline

by Goodwin on

Mazumdar-Shaw, Chairman & Managing Director of Biocon, recently stated that Biocon is developing a portfolio of 10 biosimilars, and will continue to invest 12-15% of its revenue in research and development. According to Ms....more

DOE Announces Open Biomass R&D Technical Advisory Committee Meeting

by Bergeson & Campbell, P.C. on

On August 2, 2017, DOE published a notice in the Federal Register announcing a public meeting of the Biomass Research and Development Technical Advisory Committee. The committee is comprised of approximately 30 volunteers...more

Luxembourg announces new IP tax regime

by DLA Piper on

Luxembourg has announced a new regime that offers a special tax incentive for certain income from intellectual property rights. The bill containing the new IP regime, which is expected to come into effect as of the 2018 tax...more

USDA Releases Annual Technology Transfer Report

On July 20, 2017, USDA released its technology transfer report for fiscal year 2016. The report outlines the public release of information, tools, and solutions and the adoption and enhancement of research outcomes by...more

Under the Dome: Inside the Maine State House

by Pierce Atwood LLP on

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Legislature Met on July 20 to Consider Bond Bills, Items from Special Appropriations Table - After...more

Congress of Colombia issues normativity for the promotion of technology-based companies

by Dentons on

On July 6, 2017, the Congress of the Republic enacted Law 1838 of 2017, which seeks to promote technology and innovation through the creation of technology-based companies (or Spin-offs). For the purposes foreseen in this...more

Discontinuation of Etanercept Biosimilar in Japan

by Goodwin on

On July 5, 2017, Daiichi Sankyo Company announced that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan. Daiichi had been co-developing...more

Harmonization of Clinical Research Requirements—Conflicting Common Rule and CLIA Requirements Come under the Microscope

by McDermott Will & Emery on

A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more

DOE Announces $9 Million In Funding For Biomass Research And Development

by Bergeson & Campbell, P.C. on

On June 5, 2017, the U.S. Department of Energy (DOE), in collaboration with the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA), announced that up to $9 million in funding will be...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

NIH Begins Beta Test of Million Patient Cohort

by Foley & Lardner LLP on

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

How Startups Can Protect Their IP Rights

by Revision Legal on

For businesses that are just starting out, intellectual property (IP) rights can be immensely valuable. Your IP rights could be the business asset that sets your company apart from your competitors. Equally important to...more

Health and Science Projects in Iran

by Dentons on

The Iranian pharmaceutical and healthcare products market has had steady growth during the last decade. There have been significant improvements in living standards in Iran, in particular adequate access to healthcare...more

DOE Seeks Nominations For Biomass R&D Technical Advisory Committee

On May 23, 2017, EERE published in the Federal Register a solicitation for candidates to fill vacancies on the Biomass Research and Development (R&D) Technical Advisory Committee. The committee meets quarterly to advise DOE...more

DOE Announces $72 Million In Funding For Small Business R&D

On May 24, 2017, DOE announced that 68 small businesses across 24 states will receive a total of $72 million in grants to support innovative R&D. The funding was provided by DOE’s Small Business Innovation Research (SBIR)...more

Japan Legal Update - Volume 25 | May 2017

by Jones Day on

Bill to Partially Amend the Civil Code was Passed by the House of Representatives - On April 14, 2017, the House of Representatives passed a bill to partially amend the Civil Code ("Bill"). The Bill is under deliberation in...more

May Washington Update

This month’s Washington Update provides insight into a number of energy-related developments at the federal level, including President Trump’s recently proposed budget for Fiscal Year 2018, the Senate’s failed efforts to turn...more

Analysis of Energy and Tax Proposals in the 2018 Budget Proposal

by McDermott Will & Emery on

President Trump released his budget proposal for the 2018 FY on May 23, 2017, expanding on the budget blueprint he released in March. The budget proposal and blueprint reiterate the President’s tax reform proposals to lower...more

WIPO Re:Search Unveils New Strategic Plan for Fight Against Neglected Tropical Diseases, Malaria, and TB

On May 23, 2017, the World Intellectual Property Organization (WIPO) announced a new five-year strategic plan for WIPO Re:Search to guide that initiative's activities in the fight against neglected tropical diseases, malaria,...more

Harvesting Innovation: 3 Tips for IP Managers

If you have ever gone apple picking in late season, you may recall seeing more apples on the ground than on trees. As you begin picking apples, you realize why. You haphazardly grab and yank an apple off a branch and the...more

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align...more

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