News & Analysis as of

Research and Development

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

Boston Scientific Announces Worldwide EMBLEM™ Study

by Knobbe Martens on

Boston Scientific recently announced that it is launching a worldwide study for its EMBLEM™ MRI Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) device. According to the press release, a multicenter trail of the...more

OTA & Travel Distribution Update - April 14th, 2017

by Garvey Schubert Barer on

This week’s OTA & Travel Distribution Update for the week ending April 14, 2017 is below. Additional details regarding last week’s long-awaited report on online travel by the European Commission are featured in this week’s...more

Ericsson Tests Scope of the PTAB’s Sovereign Immunity Holding

by Knobbe Martens on

On January 25, 2017, a panel of the Patent Trial and Appeal Board (PTAB) held that “Eleventh Amendment Immunity bars the institution of an inter partes review against an unconsenting state that has not waived sovereign...more

California Announces Proposed Recipients Of $23 Million In Bioenergy Grants

by Bergeson & Campbell, P.C. on

On March 24, 2017, the California Energy Commission (CEC) published a notice on the proposed recipients of up to $23 million in Electric Program Investment Charge (EPIC) funding for applied research and development (AR&D) and...more

NY Attorney General Sanctions Highlight Need for Higher Standards for mHealth Research and Development

by McDermott Will & Emery on

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims....more

EU's New Regime on Payments for Research, Use of Dealing Commissions

by Morgan Lewis on

The MiFID II regime will have ramifications for buy-side global asset managers and sell-side research providers relating to use of dealing commissions and cost allocation for research expenditures....more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

CRS Report on Science and Technology Issues in the 115th Congress Includes Nanotechnology and the NNI

by Bergeson & Campbell, P.C. on

The Congressional Research Service (CRS) prepared a March 14, 2017, report entitled Science and Technology Issues in the 115th Congress. The report outlines science and technology policy issues that may come before the 115th...more

DOE Announced Biomass Technical Advisory Meeting

by Bergeson & Campbell, P.C. on

On March 8, 2017, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) published a notice in the Federal Register regarding an open meeting of the Biomass Research and Development...more

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