Life Sciences

News & Analysis as of

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part X, The Big Data Component

Research into the human microbiome has resulted in such unprecedented amounts of data that challenges related to both interpretation and management have emerged. Somewhat paradoxically, current statistical methods have made...more

2016’s Top Patent and Trade Secret Developments for Chemistry and Nanotechnology

While 2016 saw several significant IP developments regarding the USPTO claim construction standard and the standard of review of USPTO decisions, the following three developments may have the greatest impact on how in-house...more

Smith & Nephew, Arthrex Settled Suture Anchor Patent Dispute Before Trial

On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and...more

Technology and Life Sciences IPO Survey – 2016, Full Year

This report analyzes key aspects of initial public offerings (IPOs) for technology and life sciences companies that went public in 2016. Our IPO Survey was developed for clients, friends and others interested in considering...more

The Purpose Behind Patent Law and What It Means For You

Have you ever wondered why there is a patent system in the United States? Believe it or not, the framers of the U.S. Constitution gave Congress the power to create a patent system right in the Constitution itself—Article 1,...more

Changes to Sudanese Sanctions Program Could Benefit U.S. Life Sciences Companies (A Little)

On January 13, 2017, President Obama signed the Executive Order “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions” that revoked many U.S. economic...more

Blog: Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

HHS overhauls human subjects protection regulations

The Department of Health and Human Services recently issued a final rule updating the requirements for all clinical research conducted or supported by the US federal government, widely referred to as the "Common Rule." The...more

The GDPR – Possible Impact on the Life Sciences and Healthcare Sectors

Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016, (the “GDPR”) came into force in May 2016 and introduced a number of changes to European data protection law. Such changes will impact upon...more

IP in the mix: M&A Year in Review - 2016

Around the globe and across a wide variety of industry sectors, our IP practice collaborated with our corporate and other practice areas of our firm to provide integrated legal services for our clients and friends on...more

Relocation of the EU Medicines Agency: Italy

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

Life Sciences. Major Russian legislation changes for 2016

We would like to present the overview of the most important legislation changes in life sciences for 2016....more

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Signet Closes Fourth Life Science Fund at $137 Million

Signet Healthcare Partners has announced it has closed its fourth life science fund, Signet Healthcare Partners IV L.P., with $137.2 million of capital commitments....more

Brexit: Could mutuality be the key?

With the UK Government firmly indicating a "Hard Brexit", regulatory cooperation between the UK and EU is set to be key for a number of industries post-Brexit. Jeremy Hunt, the Secretary of State for Health, has recognised...more

2016 M&A Year in Review: Our Shared Success

Around the globe and across a wide variety of industry sectors, we worked on exciting, challenging, and innovative M&A transactions throughout 2016. We are grateful that these transactions propelled us to top 10 M&A rankings...more

Global Data Privacy Snapshot 2017: How does your organisation compare?

Personal information is an increasingly valuable business asset. Technology provides the opportunity to understand and engage with customers and stakeholders like never before. Deployed carefully, it can enhance...more

Risk in Compliance Week: Part I – Forecasting

This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more

New Approach for Biologic and Biosimilar Names

FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more

2017 Hot Topics in International Arbitration for Life Sciences Companies: Third-Party Funding

Intellectual property often is the most valuable asset of a growing life sciences company, and when IP becomes the subject of a dispute, companies may lack the means to protect their rights which, in turn, could adversely...more

Evidence of Geographic Change in Central America from Genome Studies of Eciton Ant Species

"It was a sight no one could ever forget. Over the range of hills, as far as eye could see, crept a darkening hem, ever longer and broader, until the shadow spread across the slope from east to west, then downwards,...more

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