News & Analysis as of

Biotechnology

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

by Bergeson & Campbell, P.C. on

Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper. The Frank R. Lautenberg Chemical Safety for the 21st Century Act...more

European Commission Launches Bioeconomy Knowledge Centre

by Bergeson & Campbell, P.C. on

On July 26, 2017, the European Commission announced the launch of the Bioeconomy Knowledge Centre, which was created by the Joint Research Centre (JRC) and the Directorate General for Research and Innovation (DG RTD) to...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

AkzoNobel Announces First Biobased Polymer Application Agreement With Itaconix

On July 26, 2017, AkzoNobel, a member of BRAG, announced that its Specialty Chemicals business issued in final the first in a series of application agreements for biobased polymers from its collaboration with Itaconix, a...more

IP is at the heart of life sciences innovation

by Hogan Lovells on

In recent years, technology and innovation has advanced at an unprecedented pace. Flying taxi drones, self-driving cars and 3D-printers immediately come to mind. However, exciting progress has been made in life sciences 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

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of...

by Bergeson & Campbell, P.C. on

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the...more

Biomedical Research Advocacy

by Fox Rothschild LLP on

Like many other animal-related businesses universities, researchers, pharmaceutical companies, their suppliers, associated businesses and non-profit trade associations, are facing increasing scrutiny by the public who...more

NAS Publishes Report On Preparing For Future Products Of Biotechnology

by Bergeson & Campbell, P.C. on

On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a...more

Clarifying or Conforming? The EPO Bows to the European Commission

by Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product...more

Bipartisan Renewable Chemicals Bill Introduced In The House

by Bergeson & Campbell, P.C. on

On June 29, 2017, Representatives Bill Pascrell (D-NJ), Ryan Costello (R-PA), Brian Fitzpatrick (R-PA), and Linda Sánchez (D-CA) introduced the Renewable Chemicals Act of 2017 to the House. If enacted, the legislation would...more

District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

by Foley & Lardner LLP on

The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more

New York City Makes a Push to Become a Life Sciences Hotspot

by Knobbe Martens on

New York City took a step toward its goal of becoming a life sciences hub with a $5 million grant from the mayor’s office to BioLabs@NYULangone, a biotech incubator in Manhattan formed from a collaboration between BioLabs and...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

BIOCAD Announces Impending Approval of its Rituximab Biosimilar in India

by Goodwin on

On July 4, 2017, BIOCAD, a Russia biotechnology company, announced that in August 2017, it expects to receive permanent market authorization in India for Acellbia, its rituximab biosimilar. BIOCAD reports that its first...more

NAS Releases Final Report on Preparing for Future Products of Biotechnology

On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of...more

Relocation of the European Medicines Agency – France shows EMA its smooth moves

by Hogan Lovells on

With Brexit under way, the European Medicines Agency is looking for a new home. France revealed itself as a serious contender when it considered offering not just one hosting place for the Agency, but five! Up until recently,...more

BIO Announces 2017 Rosalind Franklin Award Winner

by Bergeson & Campbell, P.C. on

On June 14, 2017, the Biotechnology Innovation Organization (BIO) announced that biotech industry veteran Vonnie Estes would receive the 4th annual Rosalind Franklin Award for Leadership in Industrial Biotechnology. Estes, an...more

NCGA Launches The “Consider Corn Challenge”

by Bergeson & Campbell, P.C. on

On June 7, 2017, the National Corn Growers Association (NCGA), along with innovation facilitator NineSigma, announced the launch of a global competition to identify new and innovative uses for corn as a renewable feedstock...more

Joint Venture to Open Biosimilar Lab in Brazil

by Goodwin on

PlantForm Corporation, a Canadian biotech firm, has announced that it will begin construction this summer on a new biopharmaceutical lab in Rio de Janeiro with its partner, Brazil-based Axis Biotec Brasil. According to...more

What does Brexit mean for life sciences companies in the EU and UK?

by Hogan Lovells on

Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more

BIO International Convention 2017 Preview

BIO and the Microbiome - The 2017 BIO International Convention begins this week in San Diego. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

Global Patent Prosecution Newsletter - June 2017

Revocation Proceedings Around the World - Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more

Humira Patents Invalidated in Inter Partes Reviews

by Morgan Lewis on

AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success. The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more

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