Biotechnology

News & Analysis as of

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

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

Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more

AkzoNobel To Produce Biobased Polymers With Itaconix

On January 27, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), signed a framework joint development agreement with Itaconix, a specialty chemicals company and U.S. subsidiary of...more

EMA pilot project on tailored scientific advice to support new biosimilars

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

AkzoNobel Launches Global Chemicals Start-Up Challenge

On January 16, 2017, AkzoNobel announced the launch of Imagine Chemistry, which provides start-up firms, students, research groups, and career scientists an opportunity to collaborate with AkzoNobel experts to solve real-life...more

EMA Update concerning EU Clinical Trials portal and database

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

White House Releases Updated Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities...more

Your Daily Dose of Financial News

The recent US rejection of the TPP will have wide-reaching effects in Asia. Among them is the strong likelihood of 80s-style trade warring between Japan and the US....more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Inherent Anticipation for Biotechnology Inventions

Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2017

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 - 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2016, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

Who Owns IP Rights in the Age of Artificial Intelligence?

AI raises issues that go to the very foundations of intellectual property law, including the economic incentive to encourage certain activities, and the “moral rights” associating with according credit to authors....more

Biotech Patent Dispute Between Academics That Is Far From Academic

On December 6, 2016, the parties to the complex and soon-to-be departed world of patent interferences orally argued their positions on motions in what has been described as the “biotech trial of the century” and as “the...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more

21st Century Cures: Modernizing Public and Private Research

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

559 Results
|
View per page
Page: of 23
Popular Topics

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×