News & Analysis as of

Scientific Research

Genetic Assessment of Squash Genomes in Related Species

One of the characteristics of autumn is a harvest of vegetables in the squash family, including the ubiquitous pumpkin (equally famous for pumpkin pie and infamous for pumpkin spiced varieties of seemingly any food product). ...more

Congressional Confusion About the Federal Income Tax Credit for Research Expenditures

by Miller Canfield on

All congressional committees that have issued explanations of the pending Tax Cuts and Jobs Act may not be speaking with one voice about supporting the federal income tax credit for research expenses. That is cause for...more

Is The Decision To Divorce Genetic?

Virginia Commonwealth University recently announced the results of a new study examining the battle of nature v. nurture in divorce. According to the new study, “’Genetics, the Rearing Environment, and the Intergenerational...more

Currents - Energy Industry Insights - October 2017 #4

EPA to Restrict Scientific Advisers Who Get Agency Grants - "Pruitt did not say how restrictive the policy would be. But it has the potential to greatly reduce the body of expert scientists who could serve on the boards...more

Get your Single IRB lined up for Multi-Site Research

by Akerman LLP - Health Law Rx on

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more

Currents - Energy Industry Insights - August 2017#2

This is our second installment of Currents - our weekly energy news e-blast where we deliver the week's top energy news stories and our synopsis of why those stories are important from a legal perspective. - Appeals Court...more

Another step forward filling in blanks in the cyber security law or more questions than answers?

by Hogan Lovells on

Another step forward filling in blanks in the cyber security law or more questions than answers? On 11 July 2017, the China Cyberspace Administration ("CAC") released the draft Key Security ("Draft Regulations") for public...more

August 2017 – Regulating CRISPR genome editing in humans: where do we go from here?

by Allen & Overy LLP on

The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Six things to know about glyphosate

by DLA Piper on

Glyphosate, one of the most widely used herbicides in the world, is under scrutiny by media and plaintiff groups amid recent reports that it is potentially carcinogenic. A key ingredient in consumer and industrial...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

[Webinar] Navigating the Ins and Outs of Research Misconduct-related Litigation and Enforcement: Emerging Trends and Hot Topics -...

by Hogan Lovells on

Historically, research misconduct allegations have been investigated and resolved using specialized administrative procedures. Now, increasingly, research misconduct matters carry with them increased litigation and...more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

A Victory for Reliable Scientific Opinion in the Third Circuit

by Pepper Hamilton LLP on

A recent Third Circuit decision reinforces that courts must rigorously review - and opposing parties should challenge - the reliability of experts' methodologies. In In re Zoloft (Sertraline Hydrochloride) Products Liability...more

Boehringer Ingelheim Announces Interim Results on Adalimumab Biosimilar Candidate BI695501

by Goodwin on

Today, Boehringer Ingelheim announced the 24-week results from the Phase III VOLTAIRE®-RA study, comparing the adalimumab biosimilar candidate BI 695501 to Abbvie’s Humira® in patients with moderate- to severely-active...more

Determination on Indirect Infringement Requires Factual Record, Warranting Denial of Motion to Dismiss

by Orrick - IP Landscape on

Ever since the abolition of form complaints in patent cases, patent defendants have been incentivized to file motions to dismiss, and many have succeeded. But as Judge Gonzalez Rogers’ recent Order in this case reminds us,...more

Nations Press for International Restrictions to Govern Genetic Sequence Data

by WilmerHale on

A clash over access to and use of genetic sequence data (GSD) is currently brewing on several international fronts. To date, GSD has been routinely deposited in open-source databases such as GenBank of the National Center for...more

Sovereign immunity shields university from inventorship dispute

by Hogan Lovells on

In a case involving medical methods invented by two Nobel laureates, the U.S. Court of Appeals for the Federal Circuit has ruled that sovereign immunity prevents a third researcher from pursuing his claim of co-inventorship...more

An Opportunity to Shape Compliance with GDPR

by Hogan Lovells on

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

Is The Peer Review Crisis A Patent Application Crisis?

by JD Supra Perspectives on

Reproducibility is the cornerstone of peer-reviewed science. A surprisingly high percentage of major studies across various scientific disciplines cannot be reproduced....more

New Research Shows Potential to Prevent Medical Device-Related Infections

by Knobbe Martens on

A research team from Trinity College Dublin has recently discovered a way to reduce the incidence of medical device-associated infection resulting from biofilms. The term “biofilms” refers to organized colonies of bacteria...more

Five things academic scientists should know when pursuing their first patent application – Part II of V

The U.S. Patent and Trademark Office (USPTO) has launched a new Automated Interview Request (AIR) Form that allows practitioners to submit an online request for an interview with an examiner. The online form allows...more

Fake news? Trolls? Science, medical journals struggle with online woes

Online trolls who have wreaked havoc on traditional news sources also are bedeviling scientific and medical publications. Although experts have benefited from much greater access to information about studies and key...more

Publish or Perish? The Balance Between Public Disclosure and IP Protection in Scientific Research

by JD Supra Perspectives on

Public disclosures can destroy intellectual property rights related to the work. Scientists and their attorneys need to strike a delicate balance between competing interests. ...more

The Two Faces of Hacking: Data Scientists are Doing Bad to Do Good.

American and Canadian data scientists, librarians, hackers and activists have united in a “rogue” movement to locate and archive climate data maintained by U.S. agencies. Environmental scholars and librarians at the...more

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