News & Analysis as of

Scientific Research

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 - NorCal IP Group 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

Sustainable Development Update - February 2017 #2

by Allen Matkins on

Sustainable Development Focus - Building apartments near transit brings in more money for cities and counties - Greater Greater Washington - Feb 2 - In the Washington, DC region, apartments near train...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

SAMHSA Modernizes Regulations Governing the Confidentiality of Substance Use Disorder Records

by Shipman & Goodwin LLP on

After nearly thirty years since the last substantive change to the law, on January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published its final rule (the “Final Rule”) implementing...more

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

by Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

HHS Finalizes Toned-Down Version of Common Rule Overhaul

by McDermott Will & Emery on

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

Research Misconduct – Guilt by Association

At the allegation stage of a research misconduct matter, it may not be known which of several scientists actually committed research misconduct (assuming anyone did), resulting in more than one scientist being named as a...more

Eight Things to Know About the New Federal Substance Use Disorder Privacy Rule

by Foley & Lardner LLP on

A final rule published on January 18 implements the first major revisions to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) since 1987. It finalizes a proposal from...more

French Legal and Regulatory Update – December 2016

by Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. Please see full...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

by Robinson & Cole LLP on

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

Food and Beverage Manufacturers That Use Added Sugar Be On Alert

The public health community has been more vocal over the last several years regarding the amount of sugar being used in food and beverages. On January 4, 2017, the Praxis Project (“Plaintiff”), a public health advocacy...more

Matter of Dhanasar: A New Standard for National Interest Waivers in the United States

by Franczek Radelet P.C. on

On December 27, 2016, the AAO issued a decision that modifies the standards for granting a National Interest Waiver (NIW) in Matter of Dhanasar. This decision will impact thousands of applicants seeking U.S. permanent...more

EPA Releases Final Report on Impacts on Drinking Water from Hydraulic Fracturing

by Seyfarth Shaw LLP on

Seyfarth Synopsis: With significant objection from Industry, EPA has issued its Final Report on whether hydraulic fracturing activities can impact drinking water resources under certain circumstances. The U.S....more

Better Healthcare Newsletter from Patrick Malone - December 2016

Give a lasting holiday gift of health: Volunteer for a medical research study - That toy the kids whined about for weeks may be broken hours after emerging from the box. The gift card you gave will be frittered away,...more

Big Pharma, Big Soda spending big to battle ballot measures

Just some quick updates on some topics that the blog has followed in recent days: Big Soda, Big Pharma spending big to battle ballot measures...more

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