News & Analysis as of

Biotechnology

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

by Hogan Lovells on

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

USDA Announces $21 Million In Funding For Biobased Products

by Bergeson & Campbell, P.C. on

On September 22, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) awarded six grants totaling nearly $21.1 million to support the development of new jet fuel, biobased...more

FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outre

by Bergeson & Campbell, P.C. on

On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North...more

The Joshua Frase Foundation For Congenital Myopathy Research, Inc.

by Fox Rothschild LLP on

I recently attended the 2017 National Animal Interest Alliance (NAIA) Conference, titled “Animal Nation.” There, I heard the remarkable, heart-wrenching but uplifting story about the life of Joshua Frase and the challenges...more

A road map to life sciences M&A in the Netherlands

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

The commission assessment – a decision-making aid for EMA's relocation?

by Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

European Commission adopted legal acts to improve Good Manufacturing Practices for medicinal products

by Hogan Lovells on

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these...more

PTAB Finds Personalized Treatment Claims Unpatentable under Mayo

On August 14, 2017, the USPTO Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Ramsey, an unfavorable decision to applicants seeking to obtain claims directed to personalized medicine inventions. ...more

Blog: Pharmaceutical and Biotechnology Industry Representatives File Lawsuit Over Nevada’s Prescription Drug Transparency Bill

by Cooley LLP on

On September 1, 2017, Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization (collectively “Plaintiffs”) filed a complaint (the “Lawsuit”) in the United States District Court for the...more

Another Successful IACUC Conference Presented By The New Jersey Association For Biomedical Research

by Fox Rothschild LLP on

On September 22, 2017, the New Jersey Association for Biomedical Research (NJABR) offered its 24th Annual IACUC Conference, – “the region’s premier training conference for Institutional Animal Care and Use Committee members,...more

Global Patent Prosecution Newsletter - September 2017

Worldwide Doctrine of Equivalents and Prosecution History Estoppel - The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more

A road map to Life Sciences M&A in Russia

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

DOE Announces $8.8 Million In Funding For Algae Technology Innovation Projects

by Bergeson & Campbell, P.C. on

On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million. The projects aim to develop high-impact tools and...more

AkzoNobel, Itaconix Announce Development Of Biobased Chelates

by Bergeson & Campbell, P.C. on

On September 5, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that its Specialty Chemicals business signed an application agreement with Itaconix to develop innovative...more

NAS Publishes Interim Report On Synthetic Biology

by Bergeson & Campbell, P.C. on

On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic...more

Takeda Pharmaceuticals Explores GI Devices in New Partnership with Nanotechnology Company

by Knobbe Martens on

Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the...more

DuPont, ADM Win Innovation In Bioplastics Award

by Bergeson & Campbell, P.C. on

On August 25, 2017, the Bioplastics Division of the Plastics Industry Association (PLASTICS) awarded DuPont Industrial Biosciences and Archer Daniels Midland (ADM) the 2017 Innovation in Bioplastics Award. DuPont and ADM...more

European M&A Market Insights, Summer 2017

by Morrison & Foerster LLP on

Germany Strengthens Foreign Investment Control: New Rules to Thoroughly Screen Investments in Enlarged Number of Key Industries - Germany ends its longtime liberal approach to foreign investments by increasing its...more

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

by Hogan Lovells on

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

News from Abroad -- No Pharmaceutical Extension of Patent Term for Swiss Type Claims in Australia

The Australian Full Federal Court's recent decision in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 confirms that an extension of patent term for pharmaceutical substances does not extend to Swiss type...more

Mayo at Five: Eligibility of Diagnostic Method Claims

by Fish & Richardson on

Just over five years ago, the Supreme Court began reshaping the concept of patent-eligible subject matter in the life sciences with its decision in Mayo v Prometheus. Decisions following Mayo – from the Supreme Court to the...more

Agencies Request Public Comment On Collection Of Biobased Procurements Data

On August 28, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public...more

EMA released reflexion paper clarifying information related to the selection of starting materials

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

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