News & Analysis as of

Life Sciences

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

The Challenges Surrounding Patenting 3-D Bioprinted Organ and Tissue Technology

by Hogan Lovells on

In this hoganlovells.com interview, New York-based partner Arlene Chow talks about the emergence of 3-D bioprinting and the ability of innovators in this space to patent organ and tissue printing technology. ...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

Healthcare & Life Sciences Private Equity Deal Tracker: Cressey Acquires StatLab Medical Products from Prairie Capital

by McGuireWoods LLP on

Cressey & Co. has acquired a majority ownership position in StatLab Medical Products from Prairie Capital, according to a news release. StatLab, based in McKinney, Texas, is a developer and manufacturer of diagnostic...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

Not Another Brick in the Wall

by Arnall Golden Gregory LLP on

On June 5, 2017, Saudi Arabia, Bahrain, and the United Arab Emirates cut diplomatic ties with, and imposed an economic embargo on, Qatar. U.S. life sciences companies should be mindful that support for or compliance with this...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

The Importance of Label Licenses to Life Sciences Companies After Lexmark

On May 30, 2017, in Impression Products, Inc. v. Lexmark International, Inc., the U.S. Supreme Court held that a domestic or foreign sale of a patented product exhausts all U.S. patent rights in that product. The case was...more

Industry Perspectives On The Biosimilar Patent Dance

by Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

A Long Journey Through “Silk Road” Appeal: Second Circuit Affirms Conviction and Life Sentence of Silk Road Mastermind

On May 31, 2017, the Second Circuit issued its long-awaited decision in the “Silk Road” case, United States v. Ulbricht, (15-1815-cr) (2nd Cir. May 31, 2017) (Newman, Lynch, Droney)....more

Effective Immediately: The FDA Updates Humanitarian Device Exemption Regulations

by Faegre Baker Daniels on

On June 7, the U.S. Food & Drug Administration (FDA) announced that it is updating the humanitarian device exemption (HDE) regulations. The changes are meant to bring the regulations into compliance with the 21st Century...more

Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval

On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen...more

Patent Grace Period Laws in the IP5 Patent Offices: Some Similarities But Largely Different

Life science and other high technology companies most frequently file patent applications in five IP offices (IP5), namely: the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), the Japanese...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

Healthcare & Life Sciences Private Equity Deal Tracker: Mediware Acquires Kinnser Software

by McGuireWoods LLP on

Mediware Information Systems has announced it will acquire Kinnser Software from Insight Venture Partners. The transaction is backed by TPG Capital. Mediware, based in Lenexa, Kan., is a supplier of software for human...more

Pacemakers at Risk for Remote Tampering

A new study by WhiteScope concludes that pacemakers from four manufacturers contain security weaknesses that expose them to remote tampering. Pacemakers run on radio frequency and health care providers can adjust them to...more

Payer/Provider Digital Health Investments Increase in Q1 2017

Last September, we noted that payers and providers were expected to become increasingly active digital health strategic investors given their challenges to improve margins and outcomes....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

News Round Up - May 2017

by Morrison & Foerster LLP on

Reviving the U.S. IPO Market - A recent study based on work undertaken by the University of Florida found that the median age of companies going public in the United States in 1999 was 5 years. Between 20042016, the...more

Rx IP Update - May 2017

by Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Potential Impact of the Supreme Court’s Decision to Review the PTAB’s Practice of Issuing Partial Final Written Decisions in...

In a case with potential wide-ranging ramifications for patent validity challenges, on May 22, 2017, the Supreme Court granted a writ of certiorari in an appeal from an inter partes review (“IPR”) decision, SAS Institute v....more

Japan Legal Update - Volume 25 | May 2017

by Jones Day on

Bill to Partially Amend the Civil Code was Passed by the House of Representatives - On April 14, 2017, the House of Representatives passed a bill to partially amend the Civil Code ("Bill"). The Bill is under deliberation in...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

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