News & Analysis as of

Life Sciences Biotechnology

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

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

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

A road map to Life Sciences M&A in Poland

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

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

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

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

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

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

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

Relocation of the EU Medicines Agency – Spain

by Hogan Lovells on

"Spain is waiting for the EMA. Barcelona is ready". With this conviction, and with the conviction that everything is ready, the Spanish Minister for Health addressed the European Commissioner for Health & Food Safety, Mr...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Relocation of the EU Medicines Agency – Germany

by Hogan Lovells on

"EMA" and "gErMAny" – far more in common than mere letters - The European Medicines Agency (the "EMA"/"Agency") has reached celebrity-style status in the aftermath of the Brexit vote, and is being wooed by most European...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

Boom Predicted in Biodegradable Stent Market

by Knobbe Martens on

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Preparing Biotech Patent Applications - Ten Strategies for Success

by Knobbe Martens on

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

by Hogan Lovells on

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

by JD Supra Perspectives on

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

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

EPO Stays Proceedings Over Patentability Of Plants And Animals

by Foley & Lardner LLP on

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

21st Century Cures: Modernizing Public and Private Research

by McDermott Will & Emery on

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

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